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Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv9
  2. Primary endpoints: 2 to 1
    • Secondary endpoints: 7 to 8
    • Study description revised
    v8
  3. Enrollment target: 20 to 25v7
  4. Re-verified, no change to tracked fieldsv6
  5. Site contact updatedv5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date changed from estimate of Sep 1, 2024 to Sep 11, 2024
    • Secondary endpoints: 6 to 7
    • Site contact updated
    v4
  2. Secondary endpoints: details revised at 5 of 6 entriesv3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary endpoints revised (2)
    • Interventions: DBS switched ON (Device), DBS will remain OFF (Device) to DBS OFF (Device), DBS ON (Device)
    • Secondary endpoints: details revised at 6 of 6 entries
    • Study description expanded, about 48 words
    • Site details revised
    • Eligibility criteria expanded, about 4 words
    • Study title shortened, about 1 word
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Deep Brain Stimulation for the Treatment of Severe Refractory Self-Injurious Behaviour in Children with Autism Spectrum Disorder: A Randomized Trial To evaluate the effectiveness of deep brain stimulation (DBS) of the nucleus accumbens for the treatment of severe refractory, repetitive self-injurious behavior (SIB) in children with Autism Spectrum Disorder. Secondary objectives are to examine the effects of DBS on subtypes of SIB through functional analysis.
Trial Details
NCT Number NCT06529380
Lead Sponsor The Hospital for Sick Children
Conditions
(from sponsor)		 Self-Injurious Behavior, Autism Spectrum Disorder
Related terms Autism Spectrum Disorder, Self-Injurious Behavior
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov