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Brain pacemaker trial aims to stop Self-Harm in kids with autism

NCT ID NCT06529380

Disease control Sponsor: The Hospital for Sick Children Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether deep brain stimulation (DBS) of the nucleus accumbens can reduce severe, repetitive self-injurious behaviors in 25 children aged 5-17 with autism. Half will get active stimulation, half will have the device off, and parents will report behavior changes. The goal is to see if DBS can control these dangerous behaviors when other treatments have not worked.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
deep brain stimulation (DBS) of the nucleus accumbens
What this could lead to
If it works, this could offer a new way to control severe self-injurious behaviors in children with autism when other treatments have failed.
What could go wrong
This is a small, early-stage trial with only 25 children. DBS involves brain surgery, which carries risks like infection or bleeding. It may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder Self-Injurious Behavior

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder Self-injurious behavior

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, M5G1X8, Canada

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