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

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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 considering pDBS, as well as an important resource for making informed, patient-centered decisions.