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Principal Investigator: Joseph J. Fins
Organization: HARVARD MEDICAL SCHOOL
Fiscal Year: 2024
Award: $445,147
Funding agency: National Institute of Mental Health
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.
Terms: <Academic Medical Centers><Active Follow-up><Address><Administrative Personnel><Apoplexy><Articulation><Attitude><BRAIN initiative><Brain Research through Advancing Innovative Neurotechnologies initiative><Brain Trauma><Brain Vascular Accident><Caring><Cerebral Stroke><Cerebrovascular Apoplexy><Cerebrovascular Stroke><Clinical><Consciousness Disorders><Data><Data Collection><Deep Brain Stimulation><Delphi Technic><Delphi Technique><Devices><Disease><Disorder><Distress><Dyskinesia Syndromes><Ecologic Systems><Ecological Systems><Ecosystem><Ensure><Follow-Up Studies><Followup Studies><Future><Gilles de la Tourette syndrome><Gilles de la Tourette's Disease><Goals><Guinon's disease><Health Insurance><Impairment><Implant><Insurance><Insurance Coverage><Insurance Status><Intervention><Intervention Strategies><Intervention Trial><Interventional trial><Interview><Investigators><Investments><Learning><Life><Maintenance><Manufacturer><Maps><Mediation><Mental Depression><Mental disorders><Mental health disorders><Movement Disorder Syndromes><Movement Disorders><Negotiating><Negotiation><Neurosciences><Obsessive-Compulsive Disorder><Obsessive-Compulsive Neurosis><Participant><Personal Satisfaction><Persons><Physicians><Play><Policies><Privatization><Process><Provider><Psychiatric Disease><Psychiatric Disorder><Psychosocial Assessment and Care><Recurrence><Recurrent><Research><Research Personnel><Researchers><Resistance><Role><Stroke><Survey Instrument><Surveys><System><TBI recovery><Technology Transfer><Therapeutic><Tic Disorder, Combined Vocal and Multiple Motor><Tourette Syndrome><Tourette's><Tourette's Disease><Tourette's Disorder><Tourette's Syndrome><Traumatic Brain Injury><Traumatic Brain Injury recovery><University Medical Centers><Withdrawal><active followup><alleviate symptom><ameliorating symptom><biomedical implant><brain attack><brain implant><cerebral vascular accident><cerebrovascular accident><clinical care><cost><decrease symptom><depression><design><designing><expectation><experience><fewer symptoms><follow up><follow-up><followed up><followup><gain of function><health insurance plan><implant device><implantable device><improved><indwelling device><interventional strategy><loss of function><maladie des tics><meeting><meetings><mental illness><neural><neural implant><neurotechnology><psychiatric illness><psychological disorder><psychosocial><psychosocial assessment><psychosocial care><psychosocial studies><psychosocial support><recovery after TBI><recovery after traumatic brain injury><reduce symptoms><relieves symptoms><resistant><social role><stroked><strokes><success><symptom alleviation><symptom reduction><symptom relief><tic de Guinon><traumatic brain damage><virtual><well-being><wellbeing>