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DBS in Children With Autism

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ClinicalTrials.gov Identifier: NCT03982888
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
George Ibrahim, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Self-Injurious Behavior Procedure: Deep Brain Stimulation Device: DBS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for the Treatment of Refractory Repetitive Self-Injurious Behaviour in Children With Autism Spectrum Disorder: A Pilot Project
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DBS Treatment
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
Stimulation of the nucleus accumbens via 2 electrodes implanted in the brain per patient to reduce self-injurious behaviours.

Device: DBS

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
Other Name: Medtronic DBS Therapy (Device # 37601)




Primary Outcome Measures :
  1. Changes in repetitive behaviour [ Time Frame: 1 year ]

    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.


  2. Changes in self-injurious behaviour [ Time Frame: 1 year ]

    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.


  3. Changes in abberant behaviour [ Time Frame: 1 year ]

    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.


  4. Changes in obsessive-compulsive thoughts [ Time Frame: 1 year ]

    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.


  5. Changes in quality of life [ Time Frame: 1 year ]

    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.



Secondary Outcome Measures :
  1. Changes in physical brain abnormalities [ Time Frame: 1 year ]

    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.


  2. Changes in metabolic brain abnormalities [ Time Frame: 1 year ]

    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.


  3. Changes in activity [ Time Frame: 1 year ]
    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.

  4. Type of adverse events reported in caregiver logs [ Time Frame: 1 year ]
  5. Changes in number of complications pre and post intervention will be compared. [ Time Frame: 1 year ]


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female or Male patients between age 10-18
  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982888


Locations
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Canada, Ontario
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Nisha Mechery    416-416-813-7654 ext 201942    Nisha.Mechery@sickkids.ca   
Principal Investigator: George Ibrahim         
Sponsors and Collaborators
The Hospital for Sick Children

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Responsible Party: George Ibrahim, Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03982888     History of Changes
Other Study ID Numbers: REB1000060282
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by George Ibrahim, The Hospital for Sick Children:
deep brain stimulation

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Self-Injurious Behavior
Neurodevelopmental Disorders
Mental Disorders
Behavioral Symptoms