Deep brain stimulation clinical trials: a framework to accelerate recruitment, retention, and technology translation

Clinical trials involving deep brain stimulation (DBS) are challenging to implement due to invasiveness and complexity of the therapy, substantial barriers to participant recruitment and retention, and difficulties translating emerging technologies into routine clinical practice. The 2023 Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Workshop on Patient Recruitment in DBS Clinical Trials convened experts in clinical care, research, engineering, neuroethics, and device regulation to discuss barriers and facilitators related to recruitment, retention, and clinical translation of DBS technologies. The critical barriers to recruitment and retention included limited awareness and misinformation surrounding DBS, participant burden, and complex or inflexible trial protocols. Workshop participants identified several strategies to overcome these barriers, including improving public education, employing patient-centered study designs, engaging participants as equal stakeholders in the research, fostering partnerships with community organizations and referring clinicians, and reducing logistical, financial, and technological burdens associated with participation. Participants also identified barriers to broader clinical translation, including opaque pathways to regulatory approval and insurance coverage, access to specialized care, and adoption of new technologies. To overcome these challenges, participants emphasized the need for objective milestones, outcomes, and biomarkers, pragmatic study design, shared frameworks to support reimbursement efforts, and continued investment in multidisciplinary education and workforce development. Collectively, the workshop attendees concluded accelerating DBS innovation will require interdisciplinary collaborations among patients and patient advocates, community organizations, engineers, industry partners, researchers, clinicians, and regulatory stakeholders.