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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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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\u2013Revised 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06529380\">NCT06529380<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-110222","type":"journal-article","created":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T14:45:57Z","timestamp":1776696357000},"page":"e110222","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Electrical Stimulation of the Nucleus Accumbens for Severe, Refractory Self-Injurious Behaviour in Children (EASE-SIB): protocol for a randomised double-blinded crossover trial"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct06529380","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8094-3070","authenticated-orcid":false,"given":"Karim","family":"Mithani","sequence":"first","affiliation":[{"name":"Division of Neurosurgery, The Hospital for Sick Children, Toronto, Ontario, Canada"},{"name":"Institute of Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Savannah","family":"Sauter","sequence":"additional","affiliation":[{"name":"Department of Behavioural Psychology, Kennedy Krieger Institute, Baltimore, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louis P","family":"Hagopian","sequence":"additional","affiliation":[{"name":"Department of Behavioural Psychology, Kennedy Krieger Institute, Baltimore, Maryland, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara","family":"Breitbart","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery, The Hospital for Sick Children, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seetha","family":"Sriharan","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery, The Hospital for Sick Children, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fay","family":"Kisteroff","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery, The Hospital for Sick Children, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"MyLoi","family":"Huynh","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery, The Hospital for Sick Children, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanaeyah","family":"Malik","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, The Hospital for Sick Children, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin E","family":"Thorpe","sequence":"additional","affiliation":[{"name":"Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joelene","family":"Huber","sequence":"additional","affiliation":[{"name":"Division of Pediatric Medicine and Developmental Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carolina","family":"Gorodetsky","sequence":"additional","affiliation":[{"name":"Division of Neurology, The Hospital for Sick Children, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"George M","family":"Ibrahim","sequence":"additional","affiliation":[{"name":"Division of Neurosurgery, The Hospital for Sick Children, Toronto, Ontario, Canada"},{"name":"Institute of Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2026,4,20]]},"reference":[{"key":"2026042007451944000_16.4.e110222.1","doi-asserted-by":"crossref","unstructured":"Shawler LA , Becraft JL , Hagopian LP . 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