A placebo-controlled clinical study to assess the impact of variable complex weak magnetic fields (VCMF’s) generated by the BeCurie™ (Evolv28) device on the subjects with perceived stress and anxiety

Background Exposure to variable weak magnetic fields, reported to have shown beneficial effects on several neurological illnesses. However, existing therapies are costly, complex, and lack subject ease for frequent follow ups. In the current study, the novel BeCurie™ (Evolv28) wearable neck device that emits variable complex weak magnetic fields (VCMF’s) is evaluated for its positive impact on subjects with perceived stress and anxiety. Methods Eighteen participants were enrolled in this study. The primary outcomes of the study were to assess the improvements in perceived stress and anxiety symptoms in the BeCurie™ treated group. Stress and anxiety scores were assessed using DASS-21, HAM-A, and PSS. Quality of life was assessed using the MQoL-R questionnaire. Serum Cortisol and complete blood profile were assessed to understand the safety profile of BeCurie™ treatment. Results Participants in the BeCurie™ group showed a significant reduction in stress and anxiety scores compared to the placebo group on Day 30. Furthermore, open label study assessments on Days 60 and 90 revealed improvements in self-reported stress and anxiety scores, significant time dependent improvements in all major domains of quality of life, including physical, psychological, existential, and support-based aspects of life. No adverse events were reported during the study. Comprehensive blood profile assessment showed no significant changes in either the placebo or BeCurie™ groups. Conclusions The findings indicate that VCMF’s emitted by the BeCurie™ device can be a supporting non-invasive alternative therapy for managing stress and anxiety. Nonetheless, the limitations of the study, including the small sample size and the lack of a follow-up assessment beyond 90 days, suggest that further investigations are needed to establish the long-term efficacy of BeCurie™ in managing stress and anxiety symptoms. ### Competing Interest Statement All authors have completed the ICMJE uniform disclosure form at [www.icmje.org/coi_disclosure.pdf][1] and declare: Mr Shyam Sunder Pasumarthi and Dr Lalitha Palle are the founders of Aether Mindtech Solutions Pvt Ltd and sponsored the study. Dr Chaitanya Chakravarthi Gali is employed by My Pura Vida Wellness Pvt Ltd. Aether Mindtech Solutions Pvt Ltd and My Pura Vida Wellness Pvt Ltd had no role in the planning, conducting and analysis of data of this randomized controlled trial. Dr Mohan Krishna Jonnalagadda declares that he has no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; no other relationship or activities that could appear to have influenced the submitted work. ### Clinical Trial CTRI/2022/03/041445 ### Clinical Protocols ### Funding Statement The study was funded by the sponsor Aether Mindtech Solutions Private Limited. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Institutional Ethics Committee of Yashoda Academy of Medical Education and Research (IEC-YAMER) with registration number ECR/49/Inst/AP/2013/RR-19. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: https://www.icmje.org/coi_disclosure.pdf