Peer-reviewed article
Electrical Stimulation of the Nucleus Accumbens for Severe, Refractory Self-Injurious Behaviour in Children (EASE-SIB): protocol for a randomised double-blinded crossover trial.
Mithani K, Sauter S, Hagopian LP, Breitbart S, Sriharan S et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a protocol for a clinical trial testing deep brain stimulation of the nucleus accumbens to treat severe self-injurious behaviour in children with autism spectrum disorder who have not responded to other treatments. The study will involve 25 children who will undergo surgery and then be randomly assigned to receive stimulation on or off for 12-week periods. The trial aims to measure whether the stimulation reduces self-injurious behaviour and improves quality of life and reduces caregiver burden.
Key points
- Self-injurious behaviour is prevalent in children with neurodevelopmental disorders including autism, and some cases do not respond to available therapies
- A pilot phase I trial showed preliminary safety, feasibility and efficacy of bilateral deep brain stimulation targeting the nucleus accumbens in children with autism and severe, refractory self-injurious behaviour
- The proposed study is a randomised double-blinded crossover trial with 25 participants, comparing 12-week periods of stimulation ON versus OFF
- Primary outcome is the Repetitive Behaviour Scale-Revised total score; secondary outcomes include quality of life, caregiver burden, and direct observation of self-injurious behaviour
- After the crossover phase, all participants will enter a 6-month open-label phase with stimulation ON
Limitations
This is a protocol document describing a planned trial, not results, so it cannot tell us whether the intervention actually works or what outcomes will be achieved. The trial involves a single centre and a small sample, which may limit generalisability.
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.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Bilateral deep brain stimulation targeting the nucleus accumbens (NAc-DBS)
- Population
- 25 children with autism spectrum disorder and severe, refractory self-injurious behaviour
Key finding
A pilot phase I open-label trial demonstrated safety, feasibility and preliminary efficacy of NAc-DBS in children with profound autism and severe, refractory self-injurious behaviour