Evidence map›Paper›PMID 35109924›Full record

ArticlePilot and feasibility studies2022

An open-label prospective pilot trial of nucleus accumbens deep brain stimulation for children with autism spectrum disorder and severe, refractory self-injurious behavior: study protocol.

Han Yan, Lauren Siegel, Sara Breitbart, Carolina Gorodetsky, Alfonso Fasano, Aliya Rahim, Alvin Loh, Abhaya V Kulkarni, George M Ibrahim

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03982888 (Deep Brain Stimulation for the Treatment of Refractory Repetitive Self-Injurious Behaviour in Children With Autism Spectrum Disorder), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.4field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03982888 nacompletednot on this map

Deep Brain Stimulation for the Treatment of Refractory Repetitive Self-Injurious Behaviour in Children With Autism Spectrum Disorder: A Pilot Project

TypeinterventionalSponsorThe Hospital for Sick ChildrenRan2019 to 2024Enrolled6ConditionsAutism Spectrum Disorder, Self-Injurious BehaviorArmsDeep Brain Stimulation, DBS
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Gabapentin in the Treatment of Self-Injurious Behaviours - A Case Report.Journal of the Canadian Academy of Child and Adolescent Psychiatry = Journal de l'Academie canadienne de psychiatrie de l'enfant et de l'adolescent · 2025
    Article
  5. Review
  6. Deep brain stimulation for autism spectrum disorder.World journal of psychiatry · 2023
    Review
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Han YanDivision of Neurosurgery, The Hospital for Sick Children, 555 University Avenue, Room 1503, Toronto, ON, M5G 1X8, Canada.
Lauren SiegelNeurosciences and Mental Health Program, The Hospital for Sick Children, 555 University Avenue, Room 1503, Toronto, ON, M5G 1X8, Canada.
Sara BreitbartDivision of Neurosurgery, The Hospital for Sick Children, 555 University Avenue, Room 1503, Toronto, ON, M5G 1X8, Canada.
Carolina GorodetskyDivision of Neurology, The Hospital for Sick Children, Toronto, Canada.
Alfonso FasanoDivision of Neurology, The Hospital for Sick Children, Toronto, Canada.
Aliya RahimNeurosciences and Mental Health Program, The Hospital for Sick Children, 555 University Avenue, Room 1503, Toronto, ON, M5G 1X8, Canada.
Alvin LohSurrey Place, Toronto, Ontario, Canada.
Abhaya V KulkarniDivision of Neurosurgery, The Hospital for Sick Children, 555 University Avenue, Room 1503, Toronto, ON, M5G 1X8, Canada.
George M IbrahimDivision of Neurosurgery, The Hospital for Sick Children, 555 University Avenue, Room 1503, Toronto, ON, M5G 1X8, Canada. george.m.ibrahim@gmail.com.ORCID http://orcid.org/0000-0001-9068-8184
University of Toronto · CAHospital for Sick Children · CA

Funding

hospital for sick children 2018 Sandra Brown Health Outcomes Catalyst Grant
6 · The paper itself

Abstract

backgroundChildren and youth with autism spectrum disorder (ASD) may manifest self-injurious behaviors (SIB) that may become severe and refractory with limited pharmacologic or behavioral treatment options. Here, we present the protocol of a prospective, mixed-methods study to assess the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAcc) for children and youth with ASD and severe, refractory SIB.

methodsThis is a prospective, single-center, single-cohort, open-label, non-randomized pilot trial of 6 patients. Participants will be recruited through specialized behavioral clinics with persistent severe and refractory SIB following standard and intensive interventions. Following NAcc-DBS, participants will be enrolled in the study for 12 months. The primary objectives of the study are safety and feasibility, assessed by rate of recruitment and identification of factors impacting adherence to follow-up and study protocol. Potential treatment efficacy will be assessed by changes in the Children's Yale-Brown Obsessive-Compulsive Scale in ASD (CYBOCS-ASD), the Behavior Problems Index (BPI), the Inventory of Statements about Self-Injury (ISAS) and the Repetitive Behavior Scale-Revised (RBS-R) questionnaires. Additional clinical outcomes will be assessed, including measures of participant and caregiver quality of life, actigraph measurements, and positron emission tomography (PET) changes following DBS. DISCUSSION: This study will be the first to evaluate the effect of DBS of the NAcc on a pediatric population in a controlled, prospective trial. Secondary outcomes will improve the understanding of behavioral, neuro-imaging, and electrophysiologic changes in children with ASD and SIB treated with DBS. This trial will provide an estimated effect size of NAcc-DBS for severe refractory SIB in children with ASD in preparation for future comparative trials.

trial registrationRegistration on ClinicalTrials.gov was completed on 12 June 2019 with the Identifier: NCT03982888 .

Indexed as

Autism spectrum disorderChildrenDeep brain stimulationNucleus accumbensSelf-injurious behavior

Identifiers

PMID35109924
PMCPMC8808966
OpenAlexW4210615971

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.