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Autism Spectrum DisorderNCT03982888

Deep Brain Stimulation in Children With Autism

A study testing Deep Brain Stimulation and DBS in people with Autism Spectrum Disorder and Self-Injurious Behavior, run by The Hospital for Sick Children at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and possible effectiveness of deep brain stimulation (DBS) of the nucleus accumbens in children with autism spectrum disorder and treatment-refractory, repetitive self-injurious behavior. Read more about this study

Who is it for?
Ages 7 to 18 years
What is being tested?
Deep Brain Stimulation and DBS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteCanada
Study dates
14 Aug 2019to 31 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

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 7 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Female or Male patients between age 7-18
  • Diagnosis of Autism Spectrum Disorder (as defined by the DSM-5).
  • Failure or non eligibility of medical therapy with ongoing repetitive self-injurious behaviours, at 6 months or more after instigation of therapy. Failure is defined as a lack of improvement in self-injurious behaviours, as documented by objective evidence, including caregiver logs or clinician assessment, if the clinician has documented a baseline status prior to instigation of the medical therapy.
  • Diagnosis of secondary stereotypies, based on clinical assessment of the treating physicians with evidence of self-injury, documented in the patient records.
  • Parents or legal guardians, including caregivers, informed and able to give written consent.
  • Able to comply with all testing, follow-ups 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 or PET scanning
  • Likely to relocate away from the study site or move during the study's one year duration
  • Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that will result in significant risk from a surgical procedure.
  • Pregnancy
  • Unable to communicate adequately in English in order to complete the baseline and follow-up questionnaires.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Hospital for Sick Children

    Toronto, Ontario, M5G1X8

Other trials in Canada

About this study

Official title: Deep Brain Stimulation for the Treatment of Refractory Repetitive Self-Injurious Behaviour in Children With Autism Spectrum Disorder: A Pilot Project

The purpose of this study is to evaluate the safety and possible effectiveness of deep brain stimulation (DBS) of the nucleus accumbens in children with autism spectrum disorder and treatment-refractory, repetitive self-injurious behavior. Six (6) patients will be recruited and enrolled in this pilot study and study duration for each patient will be one (1) year. All will undergo surgical implantation of the Medtronic DBS system and will receive stimulation of the nucleus accumbens (2 electrodes per patient).This will be an open, non-blinded, non-randomized, pilot, phase I trial.Expected study duration is 36 months.

Read the detailed description

This is a phase I, non-blinded, non-randomized, pilot trial for safety and efficacy of deep brain stimulation for medically-refractory, repetitive self-injurious behaviours in children with ASD (i.e. secondary stereotypies). The trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).

Patients who meet inclusion and exclusion criteria will be identified and recruited the Neurosurgical Clinic at The Hospital for Sick Children. The study will proceed according to the schedule laid out below, and both patients and treating team will be aware of all treatment parameters at all times. Six (6) subjects will be enrolled in this study and study duration for each patient will be one (1) year. Previous phase I trials of DBS in psychiatric and Alzheimer's Disease populations have utilized 6 subjects per surgical target. Such a number is sufficient to demonstrate initial safety, as well as feasibility and clinical effectiveness.

Being tested
Deep Brain Stimulation, DBS
Keywords
deep brain stimulation
Medical subject headings
Autism Spectrum Disorder, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep Brain StimulationProcedure or surgery

    Stimulation of the nucleus accumbens via 2 electrodes implanted in the brain per patient to reduce self-injurious behaviours.

  • DBSDevice

    Also called Medtronic DBS Therapy (Device # 37601)

    Use of the Medtronic DBS device. DBS device consists of 2 parts:

    1. DBS lead, a thin wire with 2 electrical contacts implanted into pre-determined brain regions, and
    2. Implantable pulse generator, a small device containing the batter and computer source placed under the skin of the chest to generate electrical pulses
Study groups in NCT03982888
Study groupRoleWhat they receive
DBS TreatmentExperimentalDeep brain stimulation of both limbic and dysfunctional reward processing circuits for treatment of repetitive self injurious behaviours in children with ASD
Receives: Procedure: Deep Brain Stimulation; Device: DBS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in repetitive behaviour

    The Repetitive Behavior Scale-Revised (RBS-R; Bodfish, Symons, Parker \& Lewis, 2000) will be used to measure changes in repetitive behaviour pre and post intervention. The following sub-scales will be used:

    • Steretyped behaviour subscale
    • Self-injurious behaviour subscale
    • Compulsive behaviour subscale
    • Ritualistic behaviour subscale
    • Sameness behaviour subscale
    • Restricted behaviour subscale

    All subscales are scored from 0-3 as follows:

    0 = behaviour does not occur

    1. behaviour occurs and is a mild problem
    2. behaviour occurs and is a moderate problem
    3. behaviour occurs and is a severe problem Where a higher number indicates increased repetitive behaviour.

    Subscores are totaled and then an overall score is calculated.

    Measure will be completed at baseline (pre-surgery), weekly from weeks 2-6 post-surgery, bi-weekly from weeks 7-10 post surgery, monthly from weeks 11-51 post-surgery, and 1 year post surgery.

    Measured: 1 year

  2. Changes in self-injurious behaviour

    The Inventory of Statements about Self-Injury (ISAS; Klonsky \& Olino, 2008) will be used to measure changes in self-injurious behaviour pre and post intervention. The scale is scored from 0-2 as follows:

    0= not relevant

    1. somewhat relevant
    2. very relavant Where a higher number indicates increased self-injurious behaviour. Questions are scored and totaled.

    Measure will be completed at baseline (pre-surgery), weekly from weeks 2-6 post-surgery, bi-weekly from weeks 7-10 post surgery, monthly from weeks 11-51 post-surgery, and 1 year post surgery.

    Measured: 1 year

  3. Changes in abberant behaviour

    The Aberrant Behavior Checklist (Aman, Singh, Stewart \& Field, 1985) will be used to measure changes in the extent that abberant behaviour is a problem pre and post intervention. The scale is scored from 0-3 as follows:

    0= not at all a problem

    1. the behaviour is a problem but slight in degree
    2. the problem is moderately serious
    3. the problem is severe in degree Where the higher number indicates the behaviour is problematic. Questions are scored and totaled.

    Measure will be completed at baseline (pre-surgery), weekly from weeks 2-6 post-surgery, bi-weekly from weeks 7-10 post surgery, monthly from weeks 11-51 post-surgery, and 1 year post surgery.

    Measured: 1 year

  4. Changes in obsessive-compulsive thoughts

    The Yale-Brown Obsessive Compulsive Scale (Y-BOCS; Goodman, Price, Rasmussen,1989) will be used to measure changes in the amount of interference of unwanted ideas, images, or impulses pre and post intervention. The scale is scored from 0-4, where 0 represents minimal interference and 4 represents substantial interference. Questions are scored and totaled.

    Measure will be completed at baseline (pre-surgery), weekly from weeks 2-6 post-surgery, bi-weekly from weeks 7-10 post surgery, monthly from weeks 11-51 post-surgery, and 1 year post surgery.

    Measured: 1 year

  5. Changes in quality of life

    The Paediatric Quality of Life Inventory (PedsQL v. 4.0) will be used to measure changes in self-reported quality of life pre and post intervention. The statements are scored from 0-4 as follows:

    0= it is never a problem

    1 = it is almost never a problem 2= it is sometimes a problem 3 = it is often a problem 4= it is almost always a problem Where a higher score indicates the statement is a problem. All items are scored and totaled.

    Measure will be completed at baseline (pre-surgery), weekly from weeks 2-6 post-surgery, bi-weekly from weeks 7-10 post surgery, monthly from weeks 11-51 post-surgery, and 1 year post surgery.

    Measured: 1 year

Secondary outcomes (5)

  1. Changes in physical brain abnormalities

    MR images will be analyzed pre and post intervention for the following to assess physical abnormalities of the brain, including type (focal cortical dysplasia, tumor, hippocampal sclerosis, hypothalamic hamartoma, gliosis, brain atrophy), side of abnormalities (left/right/ bilateral), and location (frontal, temporal, sylvian, parietal, occipital, multilobar).

    MRI data will be collected at baseline, 6 weeks post-surgery, and 1 year post-surgery.

    Measured: 1 year

  2. Changes in metabolic brain abnormalities

    FDG-PET scans will be analyzed to measure changes in neurometabolism pre and post intervention, specifically indications of hypermetabolism in the frontal lobes, hippocampus, and lentiform nucleus.

    FDG-PET data will be collected at baseline, 6 weeks post-surgery, and 1 year post-surgery.

    Measured: 1 year

  3. Changes in activity

    Changes in activity pre and post intervention will be measured using the Actiwatch Spectrum, Phillips Respironics, Bend, OR. Actigraphy is the continuous measurement of an individual's movement. Actigraph data will be collected at baseline, 6 weeks post-surgery, and 1 year post-surgery. Actigraph data will be analyzed using MATLAB (Mathworks, Natick, MA). Measures analyzed will be maximum and minimum value amplitudes, peak to peak, variance, entropy fast fourier transform, discrete cosine function, z-transform, bispectrum.

    Measured: 1 year

  4. Type of adverse events reported in caregiver logs

    Measured: 1 year

  5. Changes in number of complications pre and post intervention will be compared.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2019
  2. Study start14 Aug 2019
  3. Primary completion1 Jan 2024
  4. Study completion31 Jan 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03982888
Sponsor's protocol ID
REB1000060282
Status last verified
Feb 2024
First submitted
3 Jun 2019
Last updated
22 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gorodetsky C, Mithani K, Breitbart S, Yan H, Zhang K, Gouveia FV, Warsi N, Suresh H, Wong SM, Huber J, Kerr EN, Kulkarni AV, Taylor MJ, P Hagopian L, Fasano A, Ibrahim GM. Deep Brain Stimulation of the Nucleus Accumbens for Severe Self-Injurious Behavior in Children: A Phase I Pilot Trial. Biol Psychiatry. 2025 Jun 15;97(12):1116-1126. doi: 10.1016/j.biopsych.2024.12.001. Epub 2024 Dec 5.

    PubMed 39645140

  • Yan H, Siegel L, Breitbart S, Gorodetsky C, Fasano A, Rahim A, Loh A, Kulkarni AV, Ibrahim GM. An open-label prospective pilot trial of nucleus accumbens deep brain stimulation for children with autism spectrum disorder and severe, refractory self-injurious behavior: study protocol. Pilot Feasibility Stud. 2022 Feb 2;8(1):24. doi: 10.1186/s40814-022-00988-3.

    PubMed 35109924

Questions about this trial

What is this clinical trial studying?

A study testing Deep Brain Stimulation and DBS in people with Autism Spectrum Disorder and Self-Injurious Behavior, 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 22 Feb 2024. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in repetitive behaviour (time frame: 1 year). The study lists 5 primary outcomes in all. 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 NCT03982888, which also lists 2 linked publications.

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 22 Feb 2024.

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Deep Brain Stimulation in Children With Autism | AzTrials