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BackgroundAnti-CGRP-(receptor-)monoclonal antibodies (anti-CGRP(R)-mAbs) represent a novel class of drugs for migraine treatment, but their long-term cerebrovascular and cardiovascular (CV) safety warrants further examination.MethodsIn this observational cohort study we assessed the CV safety for erenumab and fremanezumab in a real-world setting during a follow-up period of at least 1 year. Patients with hypertension or CV history were excluded. We conducted ECGs and collected clinical data at treatment initiation and thereafter every 3 months, including liver and kidney function, lipid-, electrolyte-and glucose levels.ResultsAmong patients receiving erenumab (n = 101) or fremanezumab (n = 92), 3.1% (6/193) developed abnormal ECGs or CV adverse events. Of these, three (1.6%) experienced moderate to severe CV adverse events (cerebellar stroke, spontaneous coronary artery dissection, and pericarditis) and discontinued treatment. The remaining three (1.6%) developed non-threatening ECG abnormalities without physical complaints. No significant changes were observed in liver and kidney function, lipid-, electrolyte-, or glucose levels.DiscussionWe observed CV events in 1.6% of patients with 1.5-year follow-up of anti-CGRP(R)-mAbs treatment. We advise awareness regarding CV events in patients with migraine undergoing CGRP-targeted treatment, not as a confirmation of increased risk but as a proactive measure to address potential multifactorial influences.

ABSTRACTBackground: As Posttraumatic stress disorder (PTSD) in adolescents significantly impacts their well-being, effective treatment is of great importance. Little is known, however, about the novel, multi-modal virtual reality supported, exposure-based psychotherapeutic interventions such as 3MDR in this population.Objective: To describe the 3MDR treatment of an adolescent with PTSD who did not respond to previous exposure-based PTSD interventions.Method: A 14-year-old girl diagnosed with PTSD received six sessions of 3MDR embedded in family therapy.Result: The patient tolerated the 3MDR intervention very well. Personalized music and self-selected pictures appeared to be a good fit, contributing to enhanced engagement in and adherence to the therapy. She no longer met criteria for PTSD post-intervention, and at 18 months follow-up.Conclusion: This case report suggests that 3MDR has potential as a trauma treatment for adolescents with treatment-resistant PTSD.

Background As provisions of mental healthcare services to military and veteran populations increases the risk to service providers developing secondary traumatic stress (STS), efforts are needed to examine the impact of delivering novel interventions which may include 3MDR. As a virtual-reality supported intervention, 3MDR exposes the patient, therapist and operator to graphic and sensory stimuli (i.e. narratives, imagery, smells, and music) in the course of the intervention. 3MDR is actively being researched at multiple sites internationally within military and veteran populations. It is, therefore, crucial to ensure the safety and wellbeing of 3MDR therapists and operators who are exposed to potentially distressing sensory stimuli. Objective The purpose of this study is to qualitatively examine the impact and experiences of STS amongst therapists and operators in delivering 3MDR. For this study, impact will be defined as therapists or operators experiencing perceived STS as a result of delivering 3MDR. Methods This exploratory qualitative study recruited 3MDR therapists and operators (N = 18) from Canada, the Netherlands, the United Kingdom, and the United States who had previously delivered 3MDR therapy. Telephone or video-conferencing interviews were used to gather data that was subsequently transcribed and thematically analyzed. Results Four themes emerged among the therapists (n = 13) and operators (n = 5): (1) personal cost and benefits of 3MDR, (2) professional paradox of a 3MDR therapist, (3) perceived effect of 3MDR on patients, and (4) recommendations for future 3MDR use. Conclusions STS was not noted to be a significant challenge for 3MDR therapists and operators. Future research may investigate optimal means of providing training and ongoing support for 3MDR therapists and operators. HIGHLIGHTS Secondary Traumatic Stress was not noted to be a significant challenge for 3MDR therapists and operators Future research may investigate optimal means of providing training and ongoing support for 3MDR therapists and operators

BackgroundIn recent years, the delivery of evidence-based therapies targeting posttraumatic stress disorder (PTSD) has been the focus of the Departments of Defense in countries such as Canada, the Netherlands, and the United States. More than 66% of military members continue to experience symptoms of PTSD that significantly impact their daily functioning and quality of life after completing evidence-based treatments. Innovative, engaging, and effective treatments for PTSD are needed. Multimodal motion-assisted memory desensitization and reconsolidation (3MDR) is an exposure-based, virtual reality–supported therapy used to treat military members and veterans with treatment-resistant PTSD. Given the demonstrated efficacy of 3MDR in recently published randomized control trials, there is both an interest in and a need to adapt the intervention to other populations affected by trauma and to improve accessibility to the treatment. ObjectiveWe aimed to further innovate, develop, and validate new and existing hardware and software components of 3MDR to enhance its mobility, accessibility, feasibility, and applicability to other populations affected by trauma, including public safety personnel (PSP), via international collaboration. MethodsThis study used a modified Delphi expert consultation method and mixed methods quasi-experimental validation with the purpose of software validation among PSP (first responders, health care providers) participants (N=35). A team of international experts from the Netherlands, the United States, and Canada met on the web on a weekly basis since September 2020 to discuss the adoption of 3MDR in real-world contexts, hardware and software development, and software validation. The evolution of 3MDR hardware and software was undertaken followed by a mixed methods software validation study with triangulation of results to inform the further development of 3MDR. ResultsThis study resulted in the identification, description, and evolution of hardware and software components and the development of new 3MDR software. Within the software validation, PSP participants widely acknowledged that the newly developed 3MDR software would be applicable and feasible for PSP affected by trauma within their professions. The key themes that emerged from the thematic analysis among the PSP included the desire for occupationally tailored environments, individually tailored immersion, and the applicability of 3MDR beyond military populations. ConclusionsWithin the modified Delphi consultation and software validation study, support for 3MDR as an intervention was communicated. PSP participants perceived that 3MDR was relevant for populations affected by trauma beyond military members and veterans. The resulting hardware and software evolution addressed the recommendations and themes that arose from PSP participants. 3MDR is a novel, structured, exposure-based, virtual reality–supported therapy that is currently used to treat military members and veterans with PTSD. Going forward, it is necessary to innovate and adapt 3MDR, as well as other trauma interventions, to increase effectiveness, accessibility, cost-effectiveness, and efficacy among other populations affected by trauma.

With the application of virtual reality (VR), tailored interventions can be created that mirror the traumatic experiences of veterans with post-traumatic stress disorder (PTSD). Visual elements can be mimicked, and auditory and other senses stimulated. In doing so, the degree of immersion can be adjusted to optimize the therapeutic process. Objectively measuring the sensory immersion is key to keep subjects within their personal window of tolerance. Based on this information the therapist can decide manipulate the sensory stimulation embedded in the treatment. The objectives of this article are to explore the different immersive design aspects of VRET that can be modified to influence the experienced presence in veterans with PTSD, and to discuss possible methods of measuring the emotional response facilitated by immersive design aspects and experienced presence. Four design aspects are discussed: system, sensory cues, narrative and challenge. We also report on a user experiment in three veterans that informed on quality and depth of immersion. Believability of the neutral virtual environment was important for maintaining the veterans’ presence within the VR experience. The immersive design aspects that were personalized and supportive in the narrative of the veteran such as music and self-selected images appeared to have a strong influence on recall and reliving of the traumatic events. Finally, in order to increase the therapeutic effect in veterans with PTSD, the highlighted design aspects should be recognized and tailored to maximize immersion in virtual reality exposure therapy.