What question did this study set out to answer?

This study aims to evaluate the effectiveness of deep brain stimulation targeting the nucleus accumbens for treating severe self-injurious behavior in children with autism.

April 22, 2026BMJ Open0 citationsOpen Access

Electrical Stimulation of the Nucleus Accumbens for Severe, Refractory Self-Injurious Behaviour in Children (EASE-SIB): protocol for a randomised double-blinded crossover trial

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KMKarim MithaniSunnybrook Health Science Centre SSSavannah SauterKennedy Krieger Institute LHLouis P. HagopianKennedy Krieger Institute

Key Points

This study aims to evaluate the effectiveness of deep brain stimulation targeting the nucleus accumbens for treating severe self-injurious behavior in children with autism.
Conducting a randomized double-blinded crossover trial with 25 subjects diagnosed with autism spectrum disorder.
Participants will experience NAc-DBS stimulation, alternating between stimulation ON and OFF over 12-week blocks.
Primary outcome measured using the Repetitive Behaviour Scale–Revised to assess differences in SIB under different stimulation conditions.
Expected to determine significant differences in SIB levels when comparing stimulation ON versus OFF.
Secondary outcomes will provide insights into quality of life and caregiver burden.
Research aims to offer preliminary evidence for the effectiveness of NAc-DBS in a vulnerable population.

Abstract

Introduction Self-injurious behaviour (SIB) consists of persistent, repetitive movements that can result in serious injury without suicidal intent. These behaviours are prevalent among children with neurodevelopmental disorders, including profound autism. Although many individuals benefit from currently available therapies, some exhibit treatment-refractory SIB that necessitates ongoing use of personal protective equipment and restraint, presumably due to stronger neurobiological drivers. We recently completed a phase I, open-label clinical trial demonstrating the safety, feasibility and preliminary efficacy of bilateral deep brain stimulation targeting the nucleus accumbens (NAc-DBS) in children with profound autism and severe, refractory SIB. The objective of the proposed study is to characterise the effectiveness of NAc-DBS in treating severe, refractory SIB in this unique and vulnerable population. Methods and analysis A single-centre, randomised double-blinded, crossover trial is proposed. Informed by the results of our pilot study, 25 subjects with autism spectrum disorder and severe, refractory SIB will undergo bilateral NAc-DBS. Following a 4-week recovery period, participants will be randomised to either group A (stimulation ON then OFF) or group B (stimulation OFF then ON). Each block will last 12 weeks, separated by a 2-week washout period. Following completion of the second block, all participants will enter a 6-month open-label phase with stimulation ON. The primary outcome is the difference in the Repetitive Behaviour Scale–Revised total score, between DBS-ON and DBS-OFF conditions. Secondary outcomes include measures of quality of life, caregiver burden, daily logs of SIB events and direct observation of SIB under structured analogues. Ethics and dissemination The proposed trial has been approved by the institutional Research Ethics Board (1000081171). Trial results will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT06529380

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Cite This Study

Mithani et al. (Wed,) studied this question.

synapsesocial.com/papers/69e866ad6e0dea528ddeb111 https://doi.org/https://doi.org/10.1136/bmjopen-2025-110222

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