Post-trial Access, Clinical Care, Psychosocial Support, and Scientific Progress in Experimental Deep Brain Stimulation Research - Project Summary Public and private research funders have heavily invested in the application of implantable neurotechnologies to improve the management of treatment-resistant conditions and loss of function (e.g., deep brain stimulation (DBS) systems for recovery after traumatic brain injury (TBI), stroke, disorders of consciousness, movement disorders, and psychiatric disorders such as obsessive-compulsive disorder (OCD) and depression). These devices are trialed with people who have had severe impairments and treatment-resistant disorders for many years. However, even when some participants show significant symptom relief or gain of function in these trials, there is no way to systematically ensure post-trial access to beneficial non-FDA approved investigational therapeutic devices. Loss of access or maintenance of promising neural interventions can cause recurrent severe, treatment-resistant conditions and distress related to loss of access and the financial difficulties associated with the costs necessary to support and maintain these devices generally without insurance coverage. Importantly, the end of the trial is just the beginning of a long readjustment process to life with these implanted neural devices for participants and care partners. They must renegotiate life roles and expectations and learn to navigate the world anew with the benefits, demands, and consequences of these emerging neurotechnologies. The goal of this research is to promote participant well-being and advance neuroscience by gaining a deeper understanding of participants and their care partners’ trajectory following DBS trials (e.g., experience with device access and maintenance, clinical care after the trial, psychosocial support needs to adjust to a life with the device), while maximizing opportunities for discovery following neural device trials. The aims of this study are (Aim 1) to examine the perspectives of post-trial participants and care partners from a diversity of DBS trials regarding their device, clinical, and psychosocial needs. To do this, we will conduct in-depth interviews with former participants in experimental DBS trials (e.g., TBI, OCD, depression, and Tourette syndrome (TS)), their care partners, and their local physicians. Interviews will examine their views, needs, and experiences regarding post-trial device access, clinical care for the DBS indication, adjustment to life post-trial, what kind of psychosocial support they believe could be helpful, and their attitudes about follow up studies. We will then (Aim 2) conduct in-depth interviews to examine the perspectives of researchers, device manufacturers, health insurance providers, and key administrative personnel (i.e., representatives of academic medical centers, FDA, and public and private research sponsors) regarding barriers and opportunities for post-trial device access, clinical care, psychosocial support, and the scientific implications of extended device access and longitudinal follow up. Finally, (Aim 3) we will use a modified policy Delphi technique to generate partnerships amongst the stakeholders to articulate the most pressing challenges and promising solutions to improve post-trial device access, clinical care, psychosocial support needs, and follow up data collection.
