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ImportanceAtrial fibrillation (AF) is the most common arrhythmia. Although patients have reported that various exposures determine when and if an AF event will occur, a prospective evaluation of patient-selected triggers has not been conducted, and the utility of characterizing presumed AF-related triggers for individual patients remains unknown.ObjectiveTo test the hypothesis that n-of-1 trials of self-selected AF triggers would enhance AF-related quality of life.Design, setting, and participantsA randomized clinical trial lasting a minimum of 10 weeks tested a smartphone mobile application used by symptomatic patients with paroxysmal AF who owned a smartphone and were interested in testing a presumed AF trigger. Participants were screened between December 22, 2018, and March 29, 2020.Interventionsn-of-1 Participants received instructions to expose or avoid self-selected triggers in random 1-week blocks for 6 weeks, and the probability their trigger influenced AF risk was then communicated. Controls monitored their AF over the same time period.Main outcomes and measuresAF was assessed daily by self-report and using a smartphone-based electrocardiogram recording device. The primary outcome comparing n-of-1 and control groups was the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score at 10 weeks. All participants could subsequently opt for additional trigger testing.ResultsOf 446 participants who initiated (mean [SD] age, 58 [14] years; 289 men [58%]; 461 White [92%]), 320 (72%) completed all study activities. Self-selected triggers included caffeine (n = 53), alcohol (n = 43), reduced sleep (n = 31), exercise (n = 30), lying on left side (n = 17), dehydration (n = 10), large meals (n = 7), cold food or drink (n = 5), specific diets (n = 6), and other customized triggers (n = 4). No significant differences in AFEQT scores were observed between the n-of-1 vs AF monitoring-only groups. In the 4-week postintervention follow-up period, significantly fewer daily AF episodes were reported after trigger testing compared with controls over the same time period (adjusted relative risk, 0.60; 95% CI, 0.43- 0.83; P

Despite both enthusiasm and concern regarding data sharing from clinical trials, few studies have documented the outputs of data sharing. The FDA has a considerable collection of raw data from drugs for their marketing authorization. An examination of data sharing with the FDA provides a snapshot into studies that this may facilitate.

We report neuropsychological and neuropathological findings for a patient (A.B.), who developed memory impairment after a cardiac arrest at age 39. A.B. was a clinical psychologist who, although unable to return to work, was an active participant in our neuropsychological studies for 24 y. He exhibited a moderately severe and circumscribed impairment in the formation of long-term, declarative memory (anterograde amnesia), together with temporally graded retrograde amnesia covering ∼5 y prior to the cardiac arrest. More remote memory for both facts and autobiographical events was intact. His neuropathology was extensive and involved the medial temporal lobe, the diencephalon, cerebral cortex, basal ganglia, and cerebellum. In the hippocampal formation, there was substantial cell loss in the CA1 and CA3 fields, the hilus of the dentate gyrus (with sparing of granule cells), and the entorhinal cortex. There was also cell loss in the CA2 field, but some remnants remained. The amygdala demonstrated substantial neuronal loss, particularly in its deep nuclei. In the thalamus, there was damage and atrophy of the anterior nuclear complex, the mediodorsal nucleus, and the pulvinar. There was also loss of cells in the medial and lateral mammillary nuclei in the hypothalamus. We suggest that the neuropathology resulted from two separate factors: the initial cardiac arrest (and respiratory distress) and the recurrent seizures that followed, which led to additional damage characteristic of temporal lobe epilepsy.

The fluent production of a signed language requires exquisite coordination of sensory, motor, and cognitive processes. Similar to speech production, language produced with the hands by fluent signers appears effortless but reflects the precise coordination of both large-scale and local cortical networks. The organization and representational structure of sensorimotor features underlying sign language phonology in these networks remains unknown. Here, we present a unique case study of high-density electrocorticography (ECoG) recordings from the cortical surface of profoundly deaf signer during awake craniotomy. While neural activity was recorded from sensorimotor cortex, the participant produced a large variety of movements in linguistic and transitional movement contexts. We found that at both single electrode and neural population levels, high-gamma activity reflected tuning for particular hand, arm, and face movements, which were organized along dimensions that are relevant for phonology in sign language. Decoding of manual articulatory features revealed a clear functional organization and population dynamics for these highly practiced movements. Furthermore, neural activity clearly differentiated linguistic and transitional movements, demonstrating encoding of language-relevant articulatory features. These results provide a novel and unique view of the fine-scale dynamics of complex and meaningful sensorimotor actions.

Although group-level evidence supports the use of behavioral interventions to enhance cognitive and emotional well-being, different interventions may be more acceptable or effective for different people. N-of-1 trials are single-patient crossover trials designed to estimate treatment effectiveness in a single patient. We designed a mobile health (mHealth) supported N-of-1 trial platform permitting US adult volunteers to conduct their own 30-day self-experiments testing a behavioral intervention of their choice (deep breathing/meditation, gratitude journaling, physical activity, or helpful acts) on daily measurements of stress, focus, and happiness. We assessed uptake of the study, perceived usability of the N-of-1 trial system, and influence of results (both reported and perceived) on enthusiasm for the chosen intervention (defined as perceived helpfulness of the chosen intervention and intent to continue performing the intervention in the future). Following a social media and public radio campaign, 447 adults enrolled in the study and 259 completed the post-study survey. Most were highly educated. Perceived system usability was high (mean scale score 4.35/5.0, SD 0.57). Enthusiasm for the chosen intervention was greater among those with higher pre-study expectations that the activity would be beneficial for them (p < 0.001), those who obtained more positive N-of-1 results (as directly reported to participants) (p < 0.001), and those who interpreted their N-of-1 study results more positively (p < 0.001). However, reported results did not significantly influence enthusiasm after controlling for participants' interpretations. The interaction between pre-study expectation of benefit and N-of-1 results interpretation was significant (p < 0.001), such that those with the lowest starting pre-study expectations reported greater intervention enthusiasm when provided with results they interpreted as positive. We conclude that N-of-1 behavioral trials can be appealing to a broad albeit highly educated and mostly female audience, that usability was acceptable, and that N-of-1 behavioral trials may have the greatest utility among those most skeptical of the intervention to begin with.

Introduction: For several years, studies have been conducted on the contribution of social robots as an intervention tool for children with autism spectrum disorder (ASD). One of the early intervention models recommended by the French National Authority for Health is the Early Start Denver Model, an individualised, intensive programme based on play activities chosen by the child. While studies published in recent years suggest that robots provide benefits for autistic children in learning social interactions within a clinical setting, there is no scientific consensus on the widespread contribution and maintenance of their effects over time. On the other hand, a robotic solution controlled directly by a practitioner (ie, on-site telepresence system) enables greater adaptability to children's responses and choices during interventions. We believe that such a solution would enable better assessment of progress in the fundamental skills of expressive communication and imitation as well as greater engagement during interventions., Methods and Analysis: This is a prospective, monocentric, descriptive and evaluative pilot study based on single-case experimental design (SCED) methodology. The study will recruit eight children diagnosed with ASD aged between 2 and 5 years. The intervention will take place 15 min after the usual weekly care. The SCED methodology is constructed in three stages: (A) 4 weekly sessions at baseline without the robot, (B) 9 weekly sessions with intervention modification using a social robot as cotherapist and (C) 4 weekly sessions without the robot for follow-up., Ethics and Dissemination: Ethical approval was obtained from the South East IV Ethics Committee (CPP Sud-Est IV) (number: 2023-A00895-40) in France. Explicit consent is required from all legal representatives (parents) of children participating in this study. We aim to disseminate the results of this study through national and international conferences, international peer-reviewed journals and social media., Trial Registration Number: NCT05991791., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: The purpose of this study was to examine the effects of Functional Reading Activities to Motivate and Empower (FRAME) on use of reading comprehension strategies in intellectually and/or developmentally disabled young adults., Method: A single-case, multiple-probe design across functional literacy stimuli (e.g., text messages, e-mails) was replicated across three intellectually or developmentally disabled 23- to 26-year-old young adults, all of whom had a primary diagnosis of autism. Within FRAME, reading comprehension strategies were taught and practiced within the context of functional texts or activities of daily living that involve written language (e.g., text messages, e-mails). Each session followed the teach-model-coach-review approach and was conducted via telepractice. Participants' use of reading comprehension strategies was measured in baseline, intervention, maintenance, and with generalization probes., Results: Visual analysis of the data indicated a functional relation between FRAME and the use of reading comprehension strategies for two of the three autistic young adults. All participants maintained increased use of reading comprehension strategies post-intervention., Conclusions: This study provides preliminary evidence that FRAME is associated with improved use of reading comprehension strategies that maintains over time. Thus, FRAME has the potential to support continued improvement of functional reading skills throughout the lifespan, which is critical as autistic individuals make the transition from adolescence to adult life. Further research is needed to evaluate the effects of the intervention on more distal outcomes of written language and to examine how to best tailor the intervention to individual differences to optimize outcomes., Supplemental Material: https://doi.org/10.23641/asha.26882422.

Background: This study focuses on the Budd app, a mobile health intervention designed for gay, bisexual, and other men who have sex with men who participate in chemsex. Chemsex, the use of psychoactive drugs in a sexual context, presents substantial health risks including increased HIV transmission and mental health issues. Addressing these risks requires innovative interventions tailored to the unique needs of this population., Objective: This study aims to evaluate the effectiveness of the Budd app in promoting drug harm reduction practices among its users, focusing on knowledge, behavioral intention, risk behavior awareness, and self-efficacy., Methods: The study used a mixed methods approach, combining a single-case experimental design and a pre-post study. A total of 10 participants from an outpatient clinic were recruited, and each attended the clinic 3 times. During the first visit, participants installed a restricted version of the Budd app, which allowed them to report daily mood and risk behavior after chemsex sessions. Phase A (baseline) lasted at least 2 weeks depending on chemsex participation. In the second visit, participants gained full access to the Budd app, initiating phase B (intervention). Phase B lasted at least 6 weeks, depending on chemsex participation, with identical data input as phase A. Participants completed pre- and postintervention surveys assessing behavioral determinants during the first and third visit., Results: The study observed an increased knowledge about chemsex substances postintervention, with a mean percentage improvement in knowledge scores of 20.59% (SD 13.3%) among participants. Behavioral intention and self-efficacy showed mixed results, with some participants improving while others experienced a decrease. There was also a variable impact on awareness of risk behavior, with half of the participants reporting a decrease postintervention. Despite these mixed results, the app was generally well-received, with participants engaging with the app's features an average of 50 times during the study., Conclusions: The Budd app showed effectiveness in enhancing knowledge about chemsex substances among gay, bisexual, and other men who have sex with men. However, its impact on safe dosing behavior, behavioral intention, self-efficacy, and risk behavior awareness was inconsistent. These findings suggest that while educational interventions can increase knowledge, translating this into behavioral change is more complex and may require more participants, a longer follow-up period, and additional strategies and support mechanisms., (©Corinne Herrijgers, Peter Verboon, Eric Florence, Heidi Vandebosch, Karolien Poels, Tom Platteau. Originally published in JMIR Formative Research (https://formative.jmir.org), 04.10.2024.)

Single-case experimental designs (SCEDs) have been used with increasing frequency to identify evidence-based interventions in education. The purpose of this study was to explore how several procedural characteristics, including within-phase variability (i.e., measurement error), number of baseline observations, and number of intervention observations influenced the magnitude of four SCED effect sizes, including (a) non-overlap of all pairs (NAP), (b) baseline corrected tau (BC-Tau), (c) mean-phase difference (MPD), and (d) generalized least squares (GLS) when applied to hypothetical academic intervention SCED data. Higher levels of measurement error decreased the average magnitude of effect sizes, particularly NAP and BC-Tau. However, the number of intervention observations had minimal impact on the average magnitude of NAP and BC-Tau. Increasing the number of intervention observations dramatically increased the magnitude of GLS and MPD. Increasing the number of baseline observations also tended to increase the average magnitude of MPD. The ratio of baseline to intervention observations had a statistically but not practically significant influence on the average magnitude of NAP, BC-Tau, and GLS. Careful consideration is required when determining the length of time academic SCEDs are conducted and what effect sizes are used to summarize treatment outcomes. This article also highlights the value of using meaningful simulation conditions to understand the performance of SCED effect sizes., (Copyright © 2024 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.)

Open science practices are designed to enhance the utility, integrity, and credibility of scientific research. This article highlights how preregistration in open science practice can be leveraged to enhance the rigor and transparency of single-case experimental designs within an applied behavior analysis framework. We provide an overview of the benefits of preregistration including increased transparency, reduced risk of researcher bias, and improved replicability, and we review the specific contexts under which these practices most benefit the proposed framework. We discuss potential concerns with and unique considerations for preregistering experiments that use single-case designs, with practical guidance for researchers who are seeking to preregister their studies. We present a checklist as a tool for researchers in applied behavior analysis to use for preregistration and provide recommendations for our field to strengthen the contingencies for open science practices that include preregistration., (© 2024 Society for the Experimental Analysis of Behavior (SEAB).)

Generalized linear mixed models (GLMMs) have great potential to deal with count data in single-case experimental designs (SCEDs). However, applied researchers have faced challenges in making various statistical decisions when using such advanced statistical techniques in their own research. This study focused on a critical issue by investigating the selection of an appropriate distribution to handle different types of count data in SCEDs due to overdispersion and/or zero-inflation. To achieve this, I proposed two model selection frameworks, one based on calculating information criteria (AIC and BIC) and another based on utilizing a multistage-model selection procedure. Four data scenarios were simulated including Poisson, negative binominal (NB), zero-inflated Poisson (ZIP), and zero-inflated negative binomial (ZINB). The same set of models (i.e., Poisson, NB, ZIP, and ZINB) were fitted for each scenario. In the simulation, I evaluated 10 model selection strategies within the two frameworks by assessing the model selection bias and its consequences on the accuracy of the treatment effect estimates and inferential statistics. Based on the simulation results and previous work, I provide recommendations regarding which model selection methods should be adopted in different scenarios. The implications, limitations, and future research directions are also discussed., (© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Purpose: The aim of this study was to pilot the efficacy of rapid syllable transition (ReST) treatment when provided once per week for a 50-min treatment session for 12 weeks with five children with childhood apraxia of speech. Of central importance was the children's retention and generalization of gains from treatment as indicators of speech motor learning., Method: A multiple-baseline across-participant design was employed to investigate (a) treatment effect on the 20 treated pseudowords, (b) generalization to 40 untreated real words and 10 untreated polysyllabic word sentences, and (c) maintenance of any treatment and generalization goals to up to 4 months posttreatment. To investigate any difference between in-session performance and retention, a comparison was made between data collected during treatment and probe sessions., Results: Treatment data collected during therapy showed all children improving across their 12 treatment sessions. Three of the five children showed a treatment effect on treated pseudowords in the probe sessions, but only one child showed generalization to untreated real words, and no children showed generalization to sentences., Conclusions: ReST treatment delivered at a dose frequency of once per week was efficacious for only one of the five children. In-session treatment data were not a reliable indicator of children's learning. One session per week of ReST therapy is therefore not recommended., Supplemental Material: https://doi.org/10.23641/asha.23751018.

Background: Worldwide, children with cerebral palsy (CP) living in underserved communities face barriers to accessing motor therapy services. This study assessed the implementation and effectiveness of an 8-week, upper limb (UL) home-based intervention with a movement-tracking videogame (Bootle Blast) in Costa Rican children with CP., Methods: Children established a weekly playtime goal and two UL activities of daily living (ADLs) that they would like to improve on. A multiple-baseline, single-case experimental design, was used with the Performance Quality Rating Scale (PQRS) as the repeated measure to track changes in performance of the selected ADLs between the baseline (usual care) and intervention (Bootle Blast) phases. The Canadian Occupational Performance Measure (COPM), the Box and Blocks Test (BBT) and the Children's Hand-Use Experience Questionnaire (CHEQ) were collected before and after the intervention. Technical barriers were documented during weekly video calls with a monitoring therapist. Treatment effect size, slope changes and percentage of non-overlapping data were identified for the PQRS. Descriptive statistics summarized results for the BBT, CHEQ, videogame logs (e.g., playtime) and technical barriers., Results: Fifteen children participated and 13 completed the intervention. Both participants who dropped out did so after completing baseline assessments, but before experiencing Bootle Blast. Children's mean active playtime (i.e., mini-games targeting the UL) across the 8-weeks was 377 min, while mean total time spent engaging with Bootle Blast (active + passive play time [e.g., time navigating menus, reviewing rewards]) was 728 min. In total, eight technical issues (from five children) were reported, and all but three were resolved within 48 h. Partial effectiveness was associated with the intervention. Specifically, 85% of participants improved on the PQRS and 69% achieved clinically important improvements ≥ 2 points in performance on the COPM. Children improved by 1.8 blocks on average on the BBT, while on the CHEQ, five children had a clinically important increase of 10% of the total number of UL activities performed with both hands., Conclusion: Bootle Blast is a feasible and effective option to facilitate access and engage children with cerebral palsy in UL home rehabilitation. Trial registration Trial registration number: NCT05403567., (© 2024. The Author(s).)

Objective: After a concussion, 1 in 3 patients report persistent symptoms and experience long-term consequences interfering with daily functioning, known as persistent concussion symptoms (PCS). Evidence suggests PCS is (partly) maintained by anxious thoughts about brain functioning, recovery, and experienced symptoms, leading to avoidance behaviors, which may prevent patients from meeting life demands. We aimed to investigate the efficacy of a newly developed intensive exposure intervention for individuals with PCS after concussion aimed to tackle avoidance behavior., Setting: Participants took part in the intervention at the Maastricht University faculty., Participants: Four participants who experienced PCS after concussion partook in the exploratory study. Participants' age ranged between 20 and 32 (mean = 26.5, SD = 5.9) years, with an average length of time after the concussion of 9.8 months., Design: A concurrent multiple-baseline single-case design was conducted. The baseline period (A phase) length was randomly determined across participants (3, 4, 5, or 6 weeks). The exposure intervention (B phase) was conducted by psychologists over a 4-week period and consisted of 3 stages: exploration (2 sessions), active exposure (12 sessions conducted over 1 week), and 2 booster sessions., Main Measures: Participants answered daily questions on a visual analog scale related to symptom experience, satisfaction with daily functioning, and degree of avoidance of feared activities. Additional outcomes included symptom severity, catastrophizing, fear of mental activity, anxiety, depression, and societal participation., Results: Tau-U yielded significant effects ( P < .05) for all participants on all measures when comparing baseline and intervention phases. The pooled standardized mean difference was high for all measures (symptom experience = 0.93, satisfaction of daily functioning = 1.86, and activity avoidance = -2.05)., Conclusions: The results show efficacy of the newly developed intensive exposure treatment for PCS after concussion, which is based on the fear avoidance model. Replication in a larger heterogeneous sample is warranted and needed., Competing Interests: The authors declare no conflict of interest. This study was not preregistered. Datasets generated and analyzed during the study are not available., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Our objective is to implement a single-case experimental design (SCED) infrastructure in combination with experience-sampling methods (ESM) into the standard diagnostic procedure of a German outpatient research and training clinic. Building on the idea of routine outcome monitoring, the SCED infrastructure introduces intensive longitudinal data collection, individual effectiveness measures, and the opportunity for systematic manipulation to push personalization efforts further. It aims to empower psychotherapists and patients to evaluate their own treatment (idiographic perspective) and to enable researchers to analyze open questions of personalized psychotherapy (nomothetic perspective). Organized around the principles of agile research, we plan to develop, implement, and evaluate the SCED infrastructure in six successive studies with continuous stakeholder involvement: In the project development phase, the business model for the SCED infrastructure is developed that describes its vision in consideration of the context (Study 1). Also, the infrastructure's prototype is specified, encompassing the SCED procedure, ESM protocol, and ESM survey (Study 2 and 3). During the optimization phase, feasibility and acceptability are tested and the infrastructure is adapted accordingly (Study 4). The evaluation phase includes a pilot implementation study to assess implementation outcomes (Study 5), followed by actual implementation using a within-institution A-B design (Study 6). The sustainability phase involves continuous monitoring and improvement. We discuss to what extent the generated data could be used to address current questions of personalized psychotherapy research. Anticipated barriers and limitations during the implementation processes are outlined., (© 2024. The Author(s).)

Background: Well-designed evaluations of psychological interventions on psychiatric intensive care units (PICUs) are a rarity., Aims: To evaluate the effectiveness of cognitive behaviour therapy for intrusive taboo thoughts with a patient diagnosed with bipolar affective disorder admitted to a PICU due to significant ongoing risk of harm to self., Method: This was a four-phase ABC plus community follow-up (D) mixed methods n =1 single case experimental design. Four idiographic measures were collected daily across four phases; the baseline (A) was during PICU admission, the first treatment phase (B) was behavioural on the PICU, the second treatment phase (C) was cognitive on an acute ward and the follow-up phase (D) was conducted in the community. Four nomothetic measures were taken on admission, on discharge from the PICU, discharge from the acute ward and then at 4-week follow-up. The participant was also interviewed at follow-up using the Change Interview., Results: Compared with baseline, the behavioural and the cognitive interventions appeared effective in terms of improving calmness, optimism and rumination, but the effects on sociability were poor. There was evidence across idiographic and nomothetic outcomes of a relapse during the follow-up phase in the community. Eleven idiographic changes were reported in the interview and these tended to be unexpected, related to the therapy and personally important., Discussion: Single case methods can be responsive to tracking the progress of patients moving through in-patient pathways and differing modules of evidence-based interventions. There is a real need to implement robust outcome methodologies on PICUs to better evaluate the psychological aspects of care in this context.

Background: In single-subject research, there is an autocorrelation between observations, that violates the assumption of observational independence. The regression discontinuity considers the correlation between observations over time and in different treatment stages (baseline, intervention, etc.). The aim of the current study was to compare the visual methods and regression discontinuity method in evaluating the effectiveness of the Lidcombe program on decreasing the severity of stuttering in primary school children of Isfahan City, Iran. Methods: This study with single-subject design was conducted on four children (7-9 years old) who stuttered. Lidcombe program treatment was performed for 22 weeks and its effectiveness on children's speech characteristics was evaluated. Stuttering severity was measured with a rating scale. In order to analyze the data, visual analysis, effect size, and regression discontinuity were used. Findings: Data analysis based on visual analyses as well as regression discontinuity indicated that most participants recorded a significant change as a decrease in severity of syllables stuttered, following the intervention. Regression coefficients in phase change from treatment to follow-up were significant, meaning that the Lidcombe program was effective over time and in phase change from the treatment stage to the follow-up. Conclusion: The results of this study show the positive effect of Lidcombe program on decreasing the severity of stuttering in children and provide the preliminary evidence for the use of this treatment method for the children with stuttering.

Psychoneuroimmunology (PNI) is a field of research that deals with the interactions between psyche, nervous, endocrine, and immune systems. Investigating these complex PNI relationships under as ecologically valid as possible conditions ("life as it is lived") necessitates a paradigm change in research. This shift places factors such as "time" and "subjective meaning" of personal experiences at the center of the research methodology. For this purpose, the biosemiotic-systemic research design "Integrative Single-Case Study" was developed. Initial results from healthy individuals as well as patients with systemic lupus erythematosus (SLE), breast cancer, and rheumatoid arthritis (RA) support the validity of the research approach. Specifically, in connection with the occurrence of emotionally meaningful everyday incidents, we repeatedly observed stress system reactions, which were (1) delayed over several days, (2) cyclically patterned, (3) anticipatory, and (4) opposing, depending on a) whether participants experienced emotionally positive or negative everyday incidents, b) whether they were healthy or ill, and c) which stress system parameter was investigated. In this chapter, the Integrative Single-Case Study design is introduced as a holistic research option, presented in detail in its methodology, and critically discussed in terms of its limitations., (© 2025. The Author(s), under exclusive license to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective. A crucial goal in brain-machine interfacing is the long-term stability of neural decoding performance, ideally without regular retraining. Long-term stability has only been previously demonstrated in non-human primate experiments and only in primary sensorimotor cortices. Here we extend previous methods to determine long-term stability in humans by identifying and aligning low-dimensional structures in neural data. Approach. Over a period of 1106 and 871 d respectively, two participants completed an imagined center-out reaching task. The longitudinal accuracy between all day pairs was assessed by latent subspace alignment using principal components analysis and canonical correlations analysis of multi-unit intracortical recordings in different brain regions (Brodmann Area 5, Anterior Intraparietal Area and the junction of the postcentral and intraparietal sulcus). Main results. We show the long-term stable representation of neural activity in subspaces of intracortical recordings from higher-order association areas in humans. Significance. These results can be practically applied to significantly expand the longevity and generalizability of brain-computer interfaces.Clinical TrialsNCT01849822, NCT01958086, NCT01964261., (Creative Commons Attribution license.)

The purpose of the current study was to examine whether seven children, aged 6-10 years, with intellectual disabilities who require augmentative and alternative communication, could acquire phonological awareness and reading skills by using a reading material that is based on research on the evidence-based reading program Accessible literacy learning. The effect of the measures has been examined using a multiple single-case design with baseline, posttest, follow-up, and maintenance. All the teachers were trained to deliver the reading intervention in the students' familiar place at school. The results indicated that students with intellectual disabilities who require augmentative and alternative communication could acquire phonological awareness and decoding by working systematically with reading material based on evidence-based strategies., Competing Interests: Declaration of Competing Interest The authors declare no conflict of interest concerning the research, authorship, and publication of this article. The first and second authors have printed the material but have not made any profit from using the reading material in the study. Use of the Widgit symbols and images from Tobii Dynavox was clarified, and contractual, and they did not receive any royalties from this., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Recent publications within Contextual Behavioral Science provided a rationale for the expansion of intervention efficacy research using methods that capture idiographic factors and processes. We conducted a systematic review of the use and quality of single-case experimental designs (SCED) within the Acceptance and Commitment Therapy (ACT) literature in adult clinical populations. The systematic review was conducted according to PRISMA guidelines and the databases CINAHL, MEDLINE, PsycINFO, PsycArticles and OpenGrey were searched for peer-reviewed articles. Further studies were sought through review of reference lists of all full text studies. Studies were assessed against What Works Clearinghouse (WWC) single-case design standards. Twenty-six studies met eligibility criteria and were conducted within research teams all implementing multiple-baseline designs. Twenty-four studies did not meet WWC standards with most failing to ensure a degree of concurrence across participants. The extent of randomisation methods was also captured. The review highlights the sparsity of SCEDs within ACT literature in clinical populations and current methodological practices. Limitations of the review and implications for future research are discussed., (Copyright © 2024 Association for Behavioral and Cognitive Therapies. Published by Elsevier Ltd. All rights reserved.)

Background: Hematopoietic cell transplantation (HCT) is a highly invasive and life-threatening treatment for hematological neoplasms and some types of cancer that can challenge the patient's meaning structures. Restoring meaning (i.e., building more flexible and significant explanations of the disease and treatment burden) can be aided by strengthening psychological flexibility by means of an Acceptance and Commitment Therapy (ACT) intervention. Thus, this trial aims to examine the effect of the ACT intervention on the meaning-making process and the underlying mechanisms of change in patients following HCT compared to a minimally enhanced usual care (mEUC) control group. The trial will be enhanced with a single-case experimental design (SCED), where ACT interventions will be compared between individuals with various pre-intervention intervals., Methods: In total, 192 patients who qualify for the first autologous or allogeneic HCT will be recruited for a two-armed parallel randomized controlled trial comparing an online self-help 14-day ACT training to education sessions (recommendations following HCT). In both conditions, participants will receive once a day a short survey and intervention proposal (about 5-10 min a day) in the outpatient period. Double-blinded assessment will be conducted at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. In addition, 6-9 participants will be invited to SCED and randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at the 2nd and 3rd post-intervention measure. The primary outcome is meaning-related distress. Secondary outcomes include psychological flexibility, meaning-making coping, meanings made, and well-being as well as global and situational meaning., Discussion: This trial represents the first study that integrates the ACT and meaning-making frameworks to reduce meaning-related distress, stimulate the meaning-making process, and enhance the well-being of HCT recipients. Testing of an intervention to address existential concerns unique to patients undergoing HCT will be reinforced by a statistically rigorous idiographic approach to see what works for whom and when. Since access to interventions in the HCT population is limited, the web-based ACT self-help program could potentially fill this gap., Trial Registration: ClinicalTrials.gov ID: NCT06266182. Registered on February 20, 2024., (© 2024. The Author(s).)

Introduction: Individuals with spinal cord injury (SCI) can experience accelerated cognitive aging. Myokines (factors released from muscle cells during contractions), such as brain-derived neurotrophic factor (BDNF), are thought to have beneficial effects on cognition. Neuromuscular electrical stimulation (NMES) was shown to elicit a large release of myokines. However, the effects of NMES on cognitive function have not been studied., Objective: To present the study protocol for a clinical trial evaluating the effects of NMES aimed at improving cognition and BDNF., Methods: A replicated randomized three-phases single-case experimental design (SCED) with sequential multiple baseline time series and a single-armed prospective trial will be conducted with 15 adults with chronic SCI (> 12 months after injury) above L1 neurological level undergoing 30-min quadriceps NMES, 3 days per week for 12 weeks., Main Study Endpoints: Primary endpoint is cognitive performance (assessed by a smartphone test) conducted three times per week during the baseline phase with random duration of 3 to 8 weeks, the intervention phase of 12 weeks, and the follow-up phase of 3 weeks after a no measurement rest period of 12 weeks. Secondary endpoints are changes in BDNF levels and cognitive performance measured before the baseline period, before and after intervention and after a 12 weeks follow-up., Conclusion: This will be the first study investigating the effects of 12 weeks NMES on both cognition and BDNF levels in individuals with SCI. The SCED results provide information on individual treatment effect courses which may direct future research., Trial Registration: ClinicalTrials.gov (NCT05822297, 12/01/2023)., (© 2024. The Author(s).)

The purpose of this research was to conduct a practice-based replication of Academic and Behavior Combined Support (ABC Support), a previously developed and experimentally evaluated supplemental intervention that merges a combined focus on reading fluency and academic engagement. In the present study, a school-based interventionist and data collector had access to implementation resources online and participated in virtual training and coaching. Four Grade 2 students received the ABC Support intervention for 6 weeks in their school. Students' oral fluency on training and non-training reading passages, as well as occurrence of engagement and disruptive behaviors during universal reading instruction, were measured repeatedly across baseline, intervention, and follow-up phases in a multiple-baseline design. In concert with prior empirical findings on ABC Support, analyses revealed improvement from baseline to intervention for both reading and behavior outcomes, as well as from baseline to follow-up assessments. Empirical contributions of the study are offered within the context of replication research and an implementation science perspective. We also emphasize the importance of telecommunication for practice-based research evaluation of interventions., (Copyright © 2024 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.)

Background: The Chronic tic disorder is a single tic or several sudden tics that continue several times a day for more than a year and it can be simple or complex. ​​Children with tic disorder stigmatized and consider the judgment of others very much, which could impair their quality of life. The purpose of this study was to explore the effectiveness of cognitive-behavioral therapy (CBT) in improving the symptoms of children with chronic tic disorder. Method: This research was a single case type A-B-A with multiple baseline design and follow-up. The study population was 10–13-year-old boys with tic disorder who referred to Astan-e-Mehr Psychiatric Clinic in Mashhad in 2018-2019. Sampling was done through purposive sampling method in which three cases (one with simple and two with complex tic disrder) were selected using a clinical interview by a clinical psychologist. The subjects responded to the Global Tic Severity Scale in baseline situations, intervention sessions, and one month after the intervention. The CBT was performed in 14 sessions. Data analysis was performed using trend chart method and the effect size. Results: The results of each subject showed a significant difference between the intervention position and baseline for three subjects with paroxysmal nocturnal dyspnea (PND) 100% for subject number one, 78% for subject number two and 86% for subject number three. Also, in the follow-up situations, the performance of all subjects was maintained., Conclusion: the CBT could be effective in improving the symptoms of children with chronic tic disorder.

Objective: The objective was to investigate the effectiveness of a person-centred active rehabilitation programme on symptoms associated with suspected Chronic Traumatic Encephalopathy (CTE). This was accomplished by (1) assessing the effect that a person-centred active rehabilitation programme had on participant symptoms, and (2) exploring how temporal contextual factors affected the participants' experience with, and perceived effectiveness of, the active rehabilitation programme., Methods: A twelve-month mixed-methods single case experimental research design was used with six cases (participants). Individual cases were involved in a 51-week study period including an initial interview and three-week baseline phase. Cases were then randomly allocated to one of two n-of-1 study designs (i.e., A-B, B-A, B-A, A-B or B-A, A-B, A-B, B-A) where A and B represent a non-intervention and intervention phase, respectively. Interviews were conducted regularly throughout the study whilst outcome measures were assessed at each follow-up. Analysis of the data included visual, statistical, and qualitative analysis., Results: Visual and statistical analysis of cognitive and executive function, and mindful attention, demonstrated trivial-to-large effects with the summary reflecting positive or unclear results. A mixed picture was observed for mood and behaviour with effects considered trivial-to-large, and the summary demonstrating positive, unclear and negative effects. Qualitative analysis indicated a perceived improvement in outcome measures such as memory, attention, anxiety, and emotional control despite mixed quantitative findings whilst a clear impact of contextual factors, such as COVID-19, the political atmosphere, exercise tolerance, programme progression, and motivation were evident during the intervention., Conclusions: This study has provided primary-level evidence to suggest active rehabilitation as a potential intervention for the management of suspected CTE symptoms. This study has also demonstrated the benefit of a person-centred approach to both clinical research and practice, particularly by considering contextual factors for a better understanding of an intervention effect., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Hearn et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Residents in nursing homes are prone to cognitive decline affecting memory, visuospatial cognition, and executive functions. Cognitive decline can lead to dementia, necessitating prioritized intervention., Methods: The current study aimed to investigate whether an intervention using a digital game was effective for preserving and improving the cognitive function of residents in nursing homes. An intervention study was conducted using a single-case AB design with multiple baselines. The participants in the study were five older adults aged 65 and over who do not play digital games regularly. The study ran for 15 weeks, including a baseline (phase A) and an intervention phase (phase B). Phase A had five baselines (5 to 9 weeks) with random participant assignment. In phase B, participants engaged in a digital game (Space Invaders) individually. Cognitive function was assessed as the outcome, measured using the Brain Assessment (performed on a tablet through the Internet) at 16 measurement points. Four of five participants (two female and two male) were included in the analysis, using visual inspection and Bayesian statistics with multi-level modeling., Results: Visual inspection of the graphs revealed cognitive function score improvements after the intervention for most layers in terms of memory of numbers, memory of words, mental rotation test (visuospatial ability), and total scores in the Brain Assessment. These effects were also significant in the analysis by multi-level modeling., Conclusions: The results suggest that the use of digital games may be effective for preserving and improving cognitive function among residents of nursing home., Trial Registration: This study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000048677; public title: Effect of a Digital Game Intervention for Cognitive Functions in Older People; registration date: August 30, 2022)., (© 2024. The Author(s).)

The discovery of new diagnostic tools for the early detection of diseases with poor prognosis such as pancreatic adenocarcinoma (PAC) is of high importance. The results from a control-case study (20 PAC patients, 19 healthy controls) for the search of new biomarkers of pancreatic cancer based in differences in the serum volatolome are presented in this work. Volatolomics were performed following a non-targeted HS-SPME-GC/MS approach, and a total of 433 volatile organic compounds (VOCs) was detected in the human serum samples. Of these, 125 VOC indexes showed a significant variation when controls and patients were compared (p-value < 0.05). Bonferroni corrected p-values < 0.05 were found for 40 features. PCA analysis showed the control-PAC discrimination capability of VOCs in serum, and PLS-DA was performed to select the best candidate biomarkers for the diagnosis of PAC. For the 40 selected VOCs, calculated areas under the curve (AUC) ranged from 0.98 to 0.85, and 11 of them were successfully validated using an independent set of samples (5 PAC patients, 5 healthy controls). Four of the proposed PAC biomarkers were identified as toluene, 2-ethyl-1-hexanol, pentylbenzene, and butoxymethylbenzene. Combinations of the identified PAC biomarkers were tested and showed AUC > 0.90, with the more promising candidate being butoxymethylbenzene (AUC = 0.98)., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: All authors are inventors of a patent application (P202330772) covering the results presented in this study, including the determination of the identified biomarkers for the diagnosis of pancreatic cancer., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Count outcomes are frequently encountered in single-case experimental designs (SCEDs). Generalized linear mixed models (GLMMs) have shown promise in handling overdispersed count data. However, the presence of excessive zeros in the baseline phase of SCEDs introduces a more complex issue known as zero-inflation, often overlooked by researchers. This study aimed to deal with zero-inflated and overdispersed count data within a multiple-baseline design (MBD) in single-case studies. It examined the performance of various GLMMs (Poisson, negative binomial [NB], zero-inflated Poisson [ZIP], and zero-inflated negative binomial [ZINB] models) in estimating treatment effects and generating inferential statistics. Additionally, a real example was used to demonstrate the analysis of zero-inflated and overdispersed count data. The simulation results indicated that the ZINB model provided accurate estimates for treatment effects, while the other three models yielded biased estimates. The inferential statistics obtained from the ZINB model were reliable when the baseline rate was low. However, when the data were overdispersed but not zero-inflated, both the ZINB and ZIP models exhibited poor performance in accurately estimating treatment effects. These findings contribute to our understanding of using GLMMs to handle zero-inflated and overdispersed count data in SCEDs. The implications, limitations, and future research directions are also discussed., (© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Randomization tests represent a class of significance tests to assess the statistical significance of treatment effects in randomized single-case experiments. Most applications of single-case randomization tests concern simple treatment effects: immediate, abrupt, and permanent changes in the level of the outcome variable. However, researchers are confronted with delayed, gradual, and temporary treatment effects; in general, with "response functions" that are markedly different from single-step functions. We here introduce a general framework that allows specifying a test statistic for a randomization test based on predicted response functions that is sensitive to a wide variety of data patterns beyond immediate and sustained changes in level: different latencies (degrees of delay) of effect, abrupt versus gradual effects, and different durations of the effect (permanent or temporary). There may be reasonable expectations regarding the kind of effect (abrupt or gradual), entailing a different focal data feature (e.g., level or slope). However, the exact amount of latency and the exact duration of a temporary effect may not be known a priori, justifying an exploratory approach studying the effect of specifying different latencies or delayed effects and different durations for temporary effects. We provide illustrations of the proposal with real data, and we present a user-friendly freely available web application implementing it., (© 2023. The Author(s).)

Single-case experimental design (SCED) data can be analyzed following different approaches. One of the first historically proposed options is randomizations tests, benefiting from the inclusion of randomization in the design: a desirable methodological feature. Randomization tests have become more feasible with the availability of computational resources, and such tests have been proposed for all major types of SCEDs: multiple-baseline, reversal/withdrawal, alternating treatments, and changing criterion designs. The focus of the current text is on the last of these, given that they have not been the subject of any previous simulation study. Specifically, we estimate type I error rates and statistical power for two different randomization procedures applicable to changing criterion designs: the phase change moment randomization and the blocked alternating criterion randomization. We include different series lengths, number of phases, levels of autocorrelation, and random variability. The results suggest that type I error rates are generally controlled and that sufficient power can be achieved with as few as 28-30 measurements for independent data, although more measurements are needed in case of positive autocorrelation. The presence of a reversal to a previous criterion level is beneficial. R code is provided for carrying out randomization tests following the two randomization procedures., (© 2023. The Author(s).)

Background: Mutations in the NMDA receptor are known to disrupt glutamatergic signaling crucial for early neurodevelopment, often leading to severe global developmental delay/intellectual disability, epileptic encephalopathy, and cerebral palsy phenotypes. Both seizures and movement disorders can be highly treatment-refractory., Results: We describe a targeted ABA n-of-1 treatment trial with intrathecal MgSO 4 , rationally designed based on the electrophysiologic properties of this gain of function mutation in the GRIN1 NMDA subunit., Conclusion: Although the invasive nature of the trial necessitated a short-term, non-randomized, unblinded intervention, quantitative longitudinal neurophysiologic monitoring indicated benefit, providing class II evidence in support of intrathecal MgSO 4 for select forms of GRIN disorders., (© 2023. Institut National de la Santé et de la Recherche Médicale (INSERM).)