Approximately, 40% of TBI patients discharged from the hospital will develop long-term disability with 70% experiencing chronic cognitive impairments that disrupt vocational, social, and emotional functioning. To foster the reentry of people with severe to moderate traumatic brain injury (smTBI) back into society, as envisioned by the Americans with Disabilities Act, we need to understand the opportunities and challenges posed by cognitive restoration. The proposed study will leverage a unique historical opportunity to obtain detailed subject and family member accounts in a first-in-human invasive neurological device trial to achieve cognitive restoration in smTBI in the ?Central Thalamic Stimulation (CT-DBS) for Traumatic Brain Injury? study (UH3 NS095554, NCT02881151). The CT-DBS study aims to test the safety and efficacy of thalamic neuromodulation as a means to achieve cognitive restoration for individuals who have regained functional independence but whose vocational and social reentry remains limited by smTBI. Based on preliminary first-in-human findings obtained from conducting in-depth, semi-structured interviews of the first UH3 participant to undergo CT-DBS and their family members, we have developed a framework to consider what ethical and legal obligations ensue following cognitive restoration. We will obtain pre and post implantation narratives from participants using semi-structured interviews. Prospectively, we elicit and analyze the perspectives of subjects and family members about their attitudes towards cognitive restoration and views about participation. We will ask how risks and benefits are weighed, what their expectations and fears are, and ascertain how decisions are reached by subject and family members in the setting of reemergent agency. After implantation has occurred, we will elicit and analyze the perspectives of persons with smTBI and their family members about the impact of cognitive impairment and restoration if it has been achieved. We will ask about any changes in personal identity, self-determination, dependency, personal responsibility, and interpersonal relationships following CT-DBS. We also ask whether cognitive restoration has prompted a reassessment of life goals and plans and inquire about challenges or barriers to social reintegration they have encountered as they rethink their lives. From this qualitative data, and drawing upon disability law, we will engage in translational legal scholarship to develop legal theory that supports social reentry for smTBI subjects for whom cognitive restoration has been achieved. The goal is to maximize patient-centered benefits of any therapeutic advance by fostering societal embodiment of this adaptive technology for a population that has been historically prone to discrimination and exclusion. Narratives from these pioneering participants will promote instrumental interdisciplinary scholarship between neuroscience, neuroethics, and the law and yield critical insights that can prepare society for the responsibility of accommodating (and embracing) scientific advances developed by the Brain Initiative.
To foster the reentry of people with severe to moderate traumatic brain injury (smTBI) back into society, as envisioned by the Americans with Disabilities Act, we need to understand the opportunities and challenges posed by cognitive restoration. The proposed study will explore the perspectives of individuals and their family members participating in the ?Central Thalamic Stimulation (CT-DBS) for Traumatic Brain Injury? study (UH3 NS095554, NCT02881151) which aims to test the safety and efficacy of CT-DBS as a means of cognitive restoration for individuals who have regained functional independence but whose vocational and social reentry remains limited by smTBI. Narratives from these pioneering participants will provide critical insights that can inform neuroethics and disability law.
