Mapping the Post-Trial Care Gaps in Deep Brain Stimulation for Psychiatric Conditions

Abstract: Implanted neural devices offer therapeutic promise for those with movement and, increasingly, psychiatric and neurological disorders. Those in clinical trials for deep brain stimulation (DBS) often turn to them as a final therapeutic option after years of navigating ineffective or limited treatment options. However, even those who show significant symptom relief and regain of function can be left unsupported after the trials end—having to navigate issues of device maintenance, financial coverage, and condition care on their own. While previous work has identified the urgency of addressing these post-trial care gaps, there remains great uncertainty regarding who (e.g., researchers, clinicians, funders, device companies, insurers) holds which responsibilities in providing participant support after the trials end.

In this paper presentation, I present preliminary findings from a project engaging a wide range of stakeholders to map out the post-trial care gaps and potential intervention points for investigational, psychiatric DBS trials. Ensuring continued participant care requires in-tandem consideration of the support needs of those caring for them. Towards this end, we interviewed former research participants, their care partners, and local clinicians to identify post-trial support gaps across these groups. We identify current barriers and avenues for improved social support, training, and material resources to improve participant outcomes and overall wellbeing.

With these intervention points identified, I outline our strategies for engaging the wider post-trial care web—including funders, researchers, insurers, and device-developers—in building pragmatic policy consensus and working towards patient-centered post-trial care norms.

Ana Lucía Battaglino, MA – Research Assistant, Center for Bioethics, Harvard Medical School; Amanda Merner, PhD – Postdoctoral Research Fellow, Center for Bioethics, Harvard Medical School; Ian Stevens, MA – Research Assistant, Center for Bioethics, Harvard Medical School; Megan Wright, JD, PhD – Professor of Law, Medicine, Sociology, and Bioethics, Penn State Law; Joseph Fins, MD – Professor of Medical Ethics & Professor of Medicine Chief, Internal Medicine, Weill Cornell Medicine; Gabriel Lázaro-Muñoz, PhD, JD – Assistant Professor of Psychiatry, Center for Bioethics, Harvard Medical School