Abstract

The objective of this presentation is to review recent neuromodulation research focused on child and adolescent psychiatry to facilitate a discussion of research design challenges, safety concerns, ethics, regulatory compliance, and future directions. A clinical child and adolescent psychiatry researcher focused on adapting transcranial magnetic stimulation (TMS) for youth will review recent studies as a framework for discussing ethical, regulatory, safety, and research design challenges. The research design and results from recent randomized controlled trials in autism spectrum disorder (ASD) and depression will be highlighted. One recent randomized controlled trial of TMS for MDD (n = 103) demonstrated a change in depressive symptom severity and encouraging tolerability and safety findings. However, the change in depressive symptoms across 6 weeks was not significantly different than sham stimulation. Another recent, double-blind, sham controlled, pilot study of TMS treatment for executive function deficits in ASD (n = 40) also demonstrated the feasibility, tolerability, and safety of TMS. However, TMS treatment did not differ from sham stimulation with respect to improvement in executive function performance. Recent commentaries have highlighted the safety and ethical considerations of adapting brain stimulation treatments for youth. Conversely, recent efforts with trigeminal nerve stimulation demonstrated efficacy for ADHD. Recent findings examining brain stimulation interventions in youth highlight the well-known challenges related to pharmacology studies in children and adolescents. However, brain stimulation interventions add another layer of complexity for research designs and ethical considerations. Future studies must carefully consider dosing parameters, brain state, targeting, and efforts to mitigate the placebo effect. Long-term outcome measures with respect to efficacy and safety are lacking in the current evidence base. Future efforts will require innovative approaches and unique collaborations.

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