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Electrical Stimulation of the Nucleus Accumbens for Severe, Refractory Self-Injurious Behaviour in Children
Karim Mithani1,2, Savannah Sauter3, Louis P Hagopian3
1Division of Neurosurgery, The Hospital for Sick Children, Toronto, Ontario, Canada.
Insights
This study investigates deep brain stimulation (DBS) for severe self-injurious behavior (SIB) in children with autism. NAc-DBS shows promise in reducing SIB, improving quality of life for affected children.
Area of Science:
- Neuroscience
- Developmental Psychology
- Clinical Trials
Background:
- Self-injurious behavior (SIB) is a significant challenge in neurodevelopmental disorders, particularly profound autism.
- Treatment-refractory SIB often requires intensive interventions like personal protective equipment and restraint.
- Previous research indicates potential benefits of nucleus accumbens deep brain stimulation (NAc-DBS) for severe SIB.
Purpose of the Study:
- To evaluate the effectiveness of bilateral NAc-DBS in treating severe, refractory SIB in children with profound autism.
- To characterize the impact of NAc-DBS on SIB severity and related outcomes in a vulnerable pediatric population.
Main Methods:
- A single-center, randomized, double-blinded, crossover trial involving 25 subjects with autism spectrum disorder and severe, refractory SIB undergoing bilateral NAc-DBS.
- Participants will be randomized to receive stimulation ON then OFF, or OFF then ON, in 12-week blocks with a 2-week washout period.
- Primary outcome: difference in Repetitive Behaviour Scale-Revised total score between DBS-ON and DBS-OFF conditions. Secondary outcomes include quality of life, caregiver burden, and SIB event logs.
Main Results:
- Preliminary findings from a Phase I trial demonstrated safety, feasibility, and preliminary efficacy of NAc-DBS.
- The proposed study aims to rigorously assess the effectiveness of NAc-DBS in reducing SIB through a randomized controlled trial design.
Conclusions:
- NAc-DBS is a potential therapeutic option for severe, treatment-refractory SIB in children with profound autism.
- Further research is warranted to confirm the efficacy and long-term benefits of NAc-DBS for this population.
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.
