Self-Injurious BehaviorNCT06529380
Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children
A study testing DBS ON and DBS OFF in people with Self-Injurious Behavior and Autism Spectrum Disorder, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Self-Injurious Behavior, Autism Spectrum Disorder
- What is being tested?
- DBS ON and DBS OFF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 11 Sep 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
MyLoi Huynh, 416-813-7654 ext. 309117, myloi.huynh@sickkids.ca
Fay Kisteroff, 416-813-7654 ext. 309014, fay.kisteroff@sickkids.ca
About this study
Official title: A Randomized Trial of Deep Brain Stimulation of the Nucleus Accumbens for Severe Self-Injurious Behaviours in Children
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.
Read the detailed description
The proposed study is a single-center, double-blinded, block-randomized crossover trial.
Twenty-five (25) participants will be recruited and enrolled in this trial to undergo bilateral nucleus accumbens DBS. After recovery, participants will be randomized to a 3 month block of active stimulation or the DBS will remain off. After a two week washout period, the participants will cross over to the other group. At the end of the second block, all patients will have their DBS devices activated during an open label period. All participants will have baseline assessments that will be repeated at the end of each block.
Expected study duration is 24 months.
- Conditions
- Self-Injurious Behavior, Autism Spectrum Disorder
- Being tested
- DBS ON, DBS OFF
- Keywords
- deep brain stimulation, DBS, ASD, SIB, nucleus accumbens
- Medical subject headings
- Self-Injurious Behavior, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS ONDevice
Electrical stimulation of the nucleus accumbens.
DBS OFFDevice
DBS will remain OFF (on at 0V).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (DBS ON, then OFF) | Active comparator | Group 1: DBS will be switched ON in Block 1 (three months) after the initial four-week post-operative period. The DBS device will then be turned OFF for two weeks ("washout period"). The device will remain OFF in Block 2 (three months). Receives: Device: DBS ON; Device: DBS OFF |
| Group 2 (DBS OFF, then ON) | Placebo comparator | Group 2: DBS will remain OFF in Block 1 (three months) after the initial four-week post-operative period. The device will remain off for two weeks thereafter ("washout period"). DBS will be switched ON in Block 2 (three months). Receives: Device: DBS ON; Device: DBS OFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repetitive Behaviors Scale-Revised (RBS-R)
A 44-item questionnaire that asks parents/caregivers how often a particular behaviour is seen occurring in the participant on a scale of 0-3, as well as a summary measure of how often the repetitive behaviours occur overall on a scale of 1-100.
Higher scores indicate greater severity.
Measured: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Secondary outcomes (8)
Self-injurious behaviour log
Parent/caregiver-reported frequency of repetitive self-injurious events over a given time period (i.e. number of events per day)
Measured: Baseline (3 months), weekly during trial
Repetitive Behaviour Questionnaire-2 (RBQ-2)
A 20-item parent/caregiver questionnaire that measures the frequency of a child's repetitive, restricted, and sensory behaviours.
Questionnaire scores can be added to give a Total Repetitive Behaviours Score, within a minimum score of 20 and a maximum score of 60 (with responses '3' and '4' combined).
Higher scores indicate greater severity.
Measured: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Self-Injurious Behavior Questionnaire (SIB-Q)
A 25-item scale with Likert-style response options that measures self-injurious behavior among those with developmental disabilities.
Scores range from 0 to 100, with higher scores indicating greater severity.
Measured: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Pediatric Quality of Life Inventory (PedsQL) Questionnaire
A parent questionnaire designed to evaluate health-related quality of life in children.
Scores range from 0 to 92, with higher scores indicating poorer quality of life.
Measured: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Autism Diagnostic Observation Schedule (ADOS) Assessment questionnaire
A standardized, activity-based assessment designed to evaluate communication skills, social interaction, and imaginative use of materials in individuals who are suspected to have autism spectrum disorder.
Classifications:
- Non-spectrum: communication <1, social interaction <3, communication + social <6
- Autism spectrum: communication >2, AND social interaction >4, AND communication + social 7-9
- Autism: communication >3, AND social interaction >6, AND communication + social >10
Higher scores indicate a greater presence of behaviours associated with autism spectrum disorder.
Measured: Baseline, 16 weeks, 30 weeks
Modified Overt Aggression Scale (MOAS) questionnaire
A brief survey of overt aggression. Scores range from 0 to 40, with higher scores indicating greater severity.
Measured: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
The Burden Scale for Family Caregivers - Short Version (BSFC-S) questionnaire
A brief survey of parental burden of care. Scores range from 0 to 30, with higher scores indicating a greater burden.
Measured: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Functional analysis (FA) assessment
An observation-based behavioural assessment that requires observing and quantifying how self-injurious behaviour (SIB) changes across conditions of a standardized and replicable assessment.
Measured: Baseline, 16 weeks, 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start11 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self-Injurious BehaviorStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Ibrahim, The Hospital for Sick Children
- Investigators
- George M Ibrahim, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529380
- Sponsor's protocol ID
- REB # 1000081171
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data from the clinical trial will be made available upon reasonable request, subject to institutional approval and, where applicable, the execution of a Data Sharing Agreement. Requests for data access should be directed to the corresponding author.
Publications
Mithani K, Sauter S, Hagopian LP, Breitbart S, Sriharan S, Kisteroff F, Huynh M, Malik S, Thorpe KE, Huber J, Gorodetsky C, Ibrahim GM. Electrical Stimulation of the Nucleus Accumbens for Severe, Refractory Self-Injurious Behaviour in Children (EASE-SIB): protocol for a randomised double-blinded crossover trial. BMJ Open. 2026 Apr 20;16(4):e110222. doi: 10.1136/bmjopen-2025-110222.
PubMed 42009381
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Deep Brain Stimulation of the Nucleus Accumbens for Severe Self-Injurious Behaviours in Children
- ClinicalTrials.gov ID
- NCT06529380
- Acronym / sponsor ID
- REB # 1000081171
- Conditions
- Self-Injurious Behavior, Autism Spectrum Disorder
- Keywords
- deep brain stimulation, DBS, ASD, SIB, nucleus accumbens
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed study is a single-center, double-blinded, block-randomized crossover trial.
Twenty-five (25) participants will be recruited and enrolled in this trial to undergo bilateral nucleus accumbens DBS. After recovery, participants will be randomized to a 3 month block of active stimulation or the DBS will remain off. After a two week washout period, the participants will cross over to the other group. At the end of the second block, all patients will have their DBS devices activated during an open label period. All participants will have baseline assessments that will be repeated at the end of each block.
Expected study duration is 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (DBS ON, then OFF) | Active comparator | Device: DBS ON, Device: DBS OFFGroup 1: DBS will be switched ON in Block 1 (three months) after the initial four-week post-operative period. The DBS device will then be turned OFF for two weeks ("washout period"). The device will remain OFF in Block 2 (three months). |
| Group 2 (DBS OFF, then ON) | Placebo comparator | Device: DBS ON, Device: DBS OFFGroup 2: DBS will remain OFF in Block 1 (three months) after the initial four-week post-operative period. The device will remain off for two weeks thereafter ("washout period"). DBS will be switched ON in Block 2 (three months). |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBS ONElectrical stimulation of the nucleus accumbens. | Device | Group 1 (DBS ON, then OFF), Group 2 (DBS OFF, then ON) |
| DBS OFFDBS will remain OFF (on at 0V). | Device | Group 1 (DBS ON, then OFF), Group 2 (DBS OFF, then ON) |
Primary outcome
Repetitive Behaviors Scale-Revised (RBS-R)
Time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
A 44-item questionnaire that asks parents/caregivers how often a particular behaviour is seen occurring in the participant on a scale of 0-3, as well as a summary measure of how often the repetitive behaviours occur overall on a scale of 1-100. Higher scores indicate greater severity.
8 secondary outcomes
Self-injurious behaviour log
Time frame: Baseline (3 months), weekly during trial
Repetitive Behaviour Questionnaire-2 (RBQ-2)
Time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Self-Injurious Behavior Questionnaire (SIB-Q)
Time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Pediatric Quality of Life Inventory (PedsQL) Questionnaire
Time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Autism Diagnostic Observation Schedule (ADOS) Assessment questionnaire
Time frame: Baseline, 16 weeks, 30 weeks
Modified Overt Aggression Scale (MOAS) questionnaire
Time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
The Burden Scale for Family Caregivers - Short Version (BSFC-S) questionnaire
Time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks
Functional analysis (FA) assessment
Time frame: Baseline, 16 weeks, 30 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 42009381Mithani K, Sauter S, Hagopian LP, Breitbart S, Sriharan S, Kisteroff F, Huynh M, Malik S, Thorpe KE, Huber J, Gorodetsky C, Ibrahim GM. Electrical Stimulation of the Nucleus Accumbens for Severe, Refractory Self-Injurious Behaviour in Children (EASE-SIB): protocol for a randomised double-blinded crossover trial. BMJ Open. 2026 Apr 20;16(4):e110222. doi: 10.1136/bmjopen-2025-110222.
- Individual participant dataSharing planned: Undecided. De-identified data from the clinical trial will be made available upon reasonable request, subject to institutional approval and, where applicable, the execution of a Data Sharing Agreement. Requests for data access should be directed to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George M Ibrahim, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS ON and DBS OFF in people with Self-Injurious Behavior and Autism Spectrum Disorder, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George M Ibrahim, MD (416-813-7500, george.ibrahim@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repetitive Behaviors Scale-Revised (RBS-R) (time frame: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06529380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.