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New treatment option for Self-Injurious Behavior
Official title Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children
ClinicalTrials.gov ID: NCT06529380
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 17
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Pregnancy.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.