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NCT03982888

Deep Brain Stimulation in Children With Autism

Completed NA Last updated 22 February 2024
What this trial tests

NA trial testing Deep Brain Stimulation in Autism Spectrum Disorder in 6 participants. Completed in 31 January 2024.

Timeline
14 August 2019
Primary endpoint
1 January 2024
31 January 2024

Quick facts

Lead sponsorThe Hospital for Sick Children
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date14 August 2019
Primary completion1 January 2024
Estimated completion31 January 2024
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

The Hospital for Sick Children

Who can join

Adults 7 to 18, any sex, with Autism Spectrum Disorder or Self-Injurious Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety and possible effectiveness of deep brain stimulation (DBS) of the nucleus accumbens in children with autism spectrum disorder and treatment-refractory, repetitive self-injurious behavior. Six (6) patients will be recruited and enrolled in this pilot study and study duration for each patient will be one (1) year. All will undergo surgical implantation of the Medtronic DBS system and will receive stimulation of the nucleus accumbens (2 electrodes per patient).This will be an open, non-blinded, non-randomized, pilot, phase I trial.Expected study duration is 36 months.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
    Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991
  2. 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.
    Yan H, Siegel L, Breitbart S, Gorodetsky C, et al · · 2022 · cited 11× · PMID 35109924 · DOI 10.1186/s40814-022-00988-3
  3. Deep Brain Stimulation of the Nucleus Accumbens for Severe Self-Injurious Behavior in Children: A Phase I Pilot Trial.
    Gorodetsky C, Mithani K, Breitbart S, Yan H, et al · · 2025 · cited 7× · PMID 39645140 · DOI 10.1016/j.biopsych.2024.12.001
  4. Deep Brain Stimulation in Pediatric Populations: A Scoping Review of the Clinical Trial Landscape.
    Jung Y, Mithani K, Suresh H, Warsi N, et al · · 2025 · cited 4× · PMID 39756376 · DOI 10.1159/000543289
  5. Regulation of autism-related self-injurious behavior by electrical stimulation of corticostriatal circuits in mice and humans.
    Zhang K, Germann J, Matin R, Mithani K, et al · · 2026 · PMID 41961929 · DOI 10.1126/sciadv.aeb5842
  6. An Open-Label Prospective Pilot Trial of Nucleus Accumbens Deep Brain Stimulation for Children with Autism Spectrum Disorder and Severe, Refractory Self-Injurious Behaviour: Study Protocol
    Yan H, Siegel L, Breitbart S, Gorodetsky C, et al · · 2021 · DOI 10.21203/rs.3.rs-440618/v1

Verify or expand the search:

Other trials of Deep Brain Stimulation

Trials testing the same drug.

Other recruiting trials for Autism Spectrum Disorder

Currently open trials in the same condition.

Other The Hospital for Sick Children trials

Trials by the same sponsor.

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Data sources for this page

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