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Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children

Autism Spectrum Disorder | Self-Injurious Behavior

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.

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    5 to 17

Critères de participation

Inclusion Criteria:

* Age 5-17 at the time of enrollment
* DSM-5 diagnosis of Autism Spectrum Disorder
* History of repetitive self-injurious behaviour, as reported by parents and documented on clinical assessment, either at the time of enrollment into the study or in prior medical records. The definition of self-injury is contextual, but requires ongoing, intermittent or continuous manifestation of self-mediated physical injury to the child.
* Foreseeable risk of serious future self-harm.
* Screening by study team for presence automatically reinforced self-injurious behaviour (ASIB) subtype 2 or subtype 3 based on caregiver history.
* Failure or non-eligibility of medical therapy with ongoing repetitive self-injurious behaviours, at 6 months or more after initiation of therapy.
* Parents or legal guardians, including caregivers, informed and able to provide written consent.
* Able to comply with all testing, follow-up visits, and study appointments and protocols for 12 months following the end of the duration of the study.

Exclusion Criteria:

* Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine.
* Any contraindication to MRI scanning.
* Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that may incur significant risk from a surgical procedure.
* Pregnancy.

Lieu de l'étude

The Hospital for Sick Children
The Hospital for Sick Children
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Backup Contact

George Ibrahim

Backup Contact

Fay Kisteroff

[email protected]
416-813-7654
Primary Contact

MyLoi Huynh

[email protected]
416-813-7654
Étude parrainée par
The Hospital for Sick Children
Participants recherchés
Plus d'informations
ID de l'étude: NCT06529380