# Pediatric Deep Brain Stimulation: Neuroethics and Decision Making: Training Supplement

> **NIH NIH RF1** · BAYLOR COLLEGE OF MEDICINE · 2020 · $164,706

## Abstract

Project Summary
Deep brain stimulation (DBS) and adaptive DBS systems are currently used in children with dystonia, epilepsy,
and Tourette Syndrome, and its use is expanding to other neuropsychiatric conditions. Yet, there is no
empirical neuroethics research that focuses on pediatric DBS (pDBS) nor any decision support tools to guide
families and clinicians through this difficult decision-making process. DBS in minors (<18 years old) raises
challenging ethical issues including the impact of DBS on agency and personal identity in developing minors,
proper balance of clinical and psychosocial risks and benefits, responsible surrogate decision making, the role
of minors in decision making, and obtaining informed assent from minors. Empirical neuroethics research is
necessary to develop informed policies to manage these ethical issues. Decision support tools or “decision
aids” (DA) are also critical in this complex clinical context because they have been shown to increase patient
understanding of interventions, accuracy of risk perceptions, promote decisions that are more aligned
with patients’ values, and improve communication with clinicians.
The long-term goal of this research is to develop empirically-informed and ethically-justified management plans
and tools for addressing pressing neuroethics issues raised by the clinical use of invasive neuromodulation in
minors. We will examine neuroethics issues (Aim 1) and decisional and informational needs of families (Aim 2)
by conducting in-depth semi-structured interviews with pDBS stakeholders for a movement disorder (dystonia)
and a psychiatric disorder (obsessive-compulsive disorder; OCD). Dystonia is the most common application of
pDBS and there is an FDA humanitarian device exemption (HDE) for the use of DBS in minors with refractory
dystonia. OCD is currently the only psychiatric disorder for which the FDA has approved the use of DBS under
an HDE (for adults) and more than 100,000 children in the U.S. suffer from refractory OCD. We will interview 1)
minors who underwent DBS for dystonia, minors for whom DBS for refractory dystonia was offered but
declined, minors with refractory dystonia who may be DBS candidates; 2) caregivers of each of the
three groups of pediatric patients listed above; and 3) clinicians of pediatric patients with refractory
dystonia. We will also interview 1) minors with refractory OCD who could be DBS candidates if it was available,
2) their caregivers, and 3) clinicians with relevant specialties. Finally, we will develop a decision aid (DA) for
caregivers considering DBS for dystonia, the most common use of pDBS (Aim 3). This DA will address
neuroethics issues (Aim 1) and decisional needs (Aim 2) and will be developed using the Ottawa Decision
Support Framework and the International Patient Decision Aids Standards. This study fills a critical gap by
providing key information about the ethical issues and tradeoffs facing families, minors, and clinicians alike
when consider...

## Key facts

- **NIH application ID:** 10030780
- **Project number:** 3RF1MH121371-01S1
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** Jennifer Blumenthal-Barby
- **Activity code:** RF1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $164,706
- **Award type:** 3
- **Project period:** 2020-02-07 → 2021-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10030780

## Citation

> US National Institutes of Health, RePORTER application 10030780, Pediatric Deep Brain Stimulation: Neuroethics and Decision Making: Training Supplement (3RF1MH121371-01S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10030780. Licensed CC0.

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