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Background: According to scientific literature, some 99% of patients affected by Alzheimer's disease (AD) suffer from behavioral and psychological symptoms of dementia (BPSD), also known as neuropsychiatric symptoms (NPSs). In particular, agitation is one of the most difficult disorders to treat. States of agitation represent a very serious problem as they make these subjects dangerous for themselves and others and worsen as the disease advances. To date, there are no specific solutions for treating agitation. The only authorized drug is risperidone (as well as brexpiprazole, approved by the FDA on 11 May 2023), which can be used for no longer than 6–12 weeks because it increases the risk of death—owing to cardiocerebrovascular accidents—by 1.6–1.7 times. Methods: In order to address the latter noteworthy unmet medical need, NanoBEO was produced. The aim of the present work is to generate the health technology assessment (HTA) of this nanotechnological device. The latter consists of a controlled release system, based on solid lipid nanoparticles loaded with bergamot essential oil (BEO). Results: The results of the present research assessed the current evidence in the field of non-pharmacological treatments for this condition, including relevant primary preclinical and clinical data studies supporting the use of this device and the production of the operative plan for its launch on the market. The findings offer recommendations for decision-making on its implementation in dementia. Conclusions: NanoBEO represents a public-worth innovation in this neglected area, marking a significant advancement in the history of dementia, moving from academic research to product development. [ABSTRACT FROM AUTHOR]

Background: An estimated 57.4 million people live with dementia worldwide, with the social burden of the disease steadily growing. Despite the approval of lecanemab and ongoing trials, there is still a lack of effective and safe treatments for behavioral and psychological symptoms of dementia (BPSD), which affect 99% of patients. Agitation is one of the most disabling BPSD, with a crosssectional prevalence of =50% in nursing homes, and refers to help-seeking behavior in response to various sources of discomfort, among which pain is a crucial component. Methods: This pilot phase of the BRAINAID (NCT04321889) trial aimed to assess the effectiveness of the patented nanotechnological device NanoBEO in older (=65 years) people with severe dementia. This randomized placebo-controlled trial, with quadruple masking that involved all operators and participants, followed the SPIRIT and CONSORT statements. A total of 29 patients completed the trial. The patients were randomly allocated in a 1:1 ratio to the NanoBEO or placebo group, and the corresponding product was applied on both arms once daily for 4 weeks, with a 4-week follow-up period. The primary endpoint was efficacy against agitation. The secondary endpoints were efficacy against agitation at follow-up and efficacy against pain. Any adverse events were reported, and biochemical analyses were performed. Results: The NanoBEO intervention reduced the frequency (28%) and level of disruptiveness of agitated behaviors. The effect on frequency was statistically significant after 2 weeks of treatment. The efficacy of NanoBEO on agitated behaviors lasted for the entire 4-week treatment period. No additional psychotropic drugs were prescribed throughout the study duration. The results after 1 week of treatment demonstrated that NanoBEO had statistically significant analgesic efficacy (45.46% improvement in pain intensity). The treatment was well tolerated. Discussion: This trial investigated the efficacy of NanoBEO therapy in managing agitation and pain in dementia. No need for rescue medications was recorded, strengthening the efficacy of NanoBEO in prolonged therapy for advanced-stage dementia and the usefulness of the intervention in the deprescription of potentially harmful drugs. This study provided a robust rationale for the application of NanoBEO in a subsequent large-scale pivotal trial to allow clinical translation of the product. [ABSTRACT FROM AUTHOR]

Individuals with acquired brain injuries (ABIs) may experience various complications related to poor coughing or impaired cough reflex (including risk of aspiration pneumonia or respiratory infections). For this reason, cough assessment is an important component in the clinical evaluation since patients with ABI are not able to cough voluntarily due to severe motor deficits. When voluntarily coughing is not possible, it is essential for clinical practices to find a quick and minimally invasive way to induce a cough reflex. In the present study, we evaluated the cough reflex in ABI patients using a new method based on a capsaicin spray stimulation test. In total, 150 healthy controls demographically matched with 50 ABI patients were included in this study. Clinical observations demonstrated robust cough response in both healthy controls and ABI patients, as well as the safety and tolerability of capsaicin spray stimulation. ABI patients with dysphagia were characterized by slower and delayed cough responses. Further studies are needed to validate this feasible, less-invasive, and simple-to-comprehend technique in inducing cough reflex. According to this preliminary evidence, we believe that this test might be translated into a simple and effective treatment to improve reflexive cough modulation in ABI patients. [ABSTRACT FROM AUTHOR]

Conventional physical therapy interventions are strongly recommended to improve ambulation potential and upright mobility in persons with incomplete spinal cord injury (iSCI). Ankle rehabilitation plays a significant role, as it aims to stem drop foot consequences. This pilot study aimed to assess the neurophysiological underpinnings of robot-aided ankle rehabilitation (using a platform robot) compared to conventional physiotherapy and its efficacy in improving gait performance and balance in persons with iSCI. Ten individuals with subacute/chronic iSCI (six males and four females, 39 ± 13 years, time since injury 8 ± 4 months, ASIA impairment scale grade C–D) were provided with one-month intensive training for robot-aided ankle rehabilitation (24 sessions, 1 h daily, six times a week). Clinical (10-Meter Walk Test (10MWT), 6–Minute Walk Test (6MWT), and Timed Up and Go test (TUG)), and electrophysiological aftereffects (surface-EMG from tibialis anterior and medial gastrocnemius muscles to estimate muscle activation patterns; and corticomuscular coherence—CMC—to assess functional synchronization between sensorimotor cortex and muscles, i.e. the functional integrity of corticospinal output) were assessed at baseline (PRE) and after the trial completion (POST). The experimental group (EG) data were compared with those coming from a retrospective control group (CG; n = 10) matched for clinical-demographic characteristics, who previously underwent conventional ankle rehabilitation. the EG achieved a greater improvement in balance and gait as compared to the CG (TUG EG from 70 ± 18 to 45 ± 15 s, p = 0.002; CG from 68 ± 21 to 48 ± 18 s, p = 0.01; group-comparison p = 0.001; 10MWT EG from 0.43 ± 0.11 to 0.51 ± 0.09 m/s, p = 0.006; CG from 0.4 ± 0.13 to 0.45 ± 0.12, p = 0.01; group-comparison p = 0.006; 6 MWT EG from 231 ± 13 to 274 ± 15 m, p < 0.001; CG from 236 ± 13 to 262 ± 15 m, p = 0.003; group-comparison p = 0.01). Furthermore, the EG showed a retraining of muscle activation (an increase within proper movements, with a reduction of co-contractions) and CMC (beta frequency increase within proper movements, i.e. in a framework of preserved motor coordination). The improvements in CMC, gait, balance, and muscle activation were not correlated with each other. Robot-aided ankle rehabilitation improved gait performance by selectively ameliorating CMC, muscle activation patterns, and, lastly, gait balance and speed. Despite CMC, gait, balance, and muscle activation were not correlated, this pilot study suggests that robot-aided ankle rehabilitation may favor a better communication between above-SCI and below-SCI structures. This communication improvement may depend on a more synchronized corticospinal output (as per CMC increase) and a better responsiveness of below-SCI motorneurons to corticospinal output (as per specific and ankle movement focused muscle activation increases at the surface EMG), thus favoring greater recruitment of spinal motor units and, ultimately, improving muscle activation pattern and strength. Adopting robot-aided ankle rehabilitation protocols for persons with iSCI in the subacute/chronic phase may allow achieving a clinically significant improvement in gait performance. [ABSTRACT FROM AUTHOR]