# Post-trial Access, Clinical Care, Psychosocial Support, and Scientific Progress in Experimental Deep Brain Stimulation Research

> **NIH NIH R01** · HARVARD MEDICAL SCHOOL · 2024 · $445,147

## Abstract

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 u...

## Key facts

- **NIH application ID:** 10910157
- **Project number:** 5R01MH133657-02
- **Recipient organization:** HARVARD MEDICAL SCHOOL
- **Principal Investigator:** Joseph J. Fins
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $445,147
- **Award type:** 5
- **Project period:** 2023-08-18 → 2024-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10910157

## Citation

> US National Institutes of Health, RePORTER application 10910157, Post-trial Access, Clinical Care, Psychosocial Support, and Scientific Progress in Experimental Deep Brain Stimulation Research (5R01MH133657-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10910157. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*