Deep Brain Stimulation in Children With Autism

NCT03982888 | Completed

• 1 other identifier: REB1000060282
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autism Spectrum Disorder; Self-Injurious Behavior

Keywords

deep brain stimulation

Outcome Measures

Primary Outcomes (5)

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

Secondary Outcomes (5)

• Changes in physical brain abnormalities

  1 year

• Changes in metabolic brain abnormalities

  1 year

• Changes in activity

  1 year

• Type of adverse events reported in caregiver logs

  1 year

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

  1 year

Study Arms (1)

DBS Treatment

EXPERIMENTAL

Deep brain stimulation of both limbic and dysfunctional reward processing circuits for treatment of repetitive self injurious behaviours in children with ASD

Procedure: Deep Brain Stimulation; Device: DBS

Interventions

Deep Brain Stimulation PROCEDURE

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

DBS Treatment

DBS DEVICE

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

Also known as: Medtronic DBS Therapy (Device # 37601)

DBS Treatment

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (2)

• 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.

  PMID: 39645140 DERIVED

• 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.

  PMID: 35109924 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Self-Injurious Behavior

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• George Ibrahim, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 12, 2019
• Study Start: August 14, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 31, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)