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Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD (TMS for ASD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04532424
Recruitment Status : Suspended (Recruitment is currently suspended due to a change in PI and staff training is required.)
First Posted : August 31, 2020
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
Antonio Hardan, Stanford University

Study Description
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Brief Summary:
Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Autism Asperger Syndrome Device: Transcranial magnetic stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to one of 2 groups based on the presentation of restricted and repetitive behavior.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Targeting insistence on sameness Device: Transcranial magnetic stimulation
Non-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine.
Experimental: Targeting stereotyped motor behaviors Device: Transcranial magnetic stimulation
Non-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine.


Outcome Measures
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Primary Outcome Measures :
  1. Repetitive Behavior Scale-Revised (RBS-R) [ Time Frame: Up to one month post-treatment ]
    44-item parent-report questionnaire to measure restricted and repetitive behavior in ASD. We predict that each TMS target will selectively reduce the subscale being targeted.


Secondary Outcome Measures :
  1. Set-shifting performance (Dimensional Change Card Sort Test score) [ Time Frame: Baseline & immediately after treatment ]
    The Dimensional Change Card Sort Test one of the cognitive measures from the NIH toolbox. These measures are administered on an iPad. The test takes 4 minutes to complete.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Autism Spectrum Disorder (ASD), Asperger's or Autism.
  2. Meet criteria for ASD on clinical assessments (ADOS-2 or CARS/BOSA if conducted remotely & ADI-R)
  3. Aged between 12-45 years old
  4. Have a reliable informant who can complete relevant questionnaires
  5. Must have previously not responded or not tolerated 2 treatments.

Exclusion Criteria:

  1. Any contraindications for TMS e.g. history of seizures
  2. Pregnancy
  3. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
  4. Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
  5. Showing symptoms of withdrawal from alcohol or benzodiazepines
  6. DSM-5 diagnosis of bipolar disorder or a psychotic disorder e.g. schizophrenia.
  7. Significant sensory impairments such as blindness or deafness.
  8. Any other indication the PI feels would comprise data
  9. Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation)
  10. IQ<50 or not testable using IQ measures and no historical IQ score available
  11. Currently taking Clozapine or another medication that the PI determines increases the risk of TMS or may disrupt the efficacy.
  12. A motor threshold that is too high to allow safe/tolerable treatment.
Contacts and Locations
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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): NCT04532424


Locations
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United States, California
Robin Libove
Stanford, California, United States, 94305-5719
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Antonio Y. Hardan, MD Stanford University
More Information
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Publications:

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Responsible Party: Antonio Hardan, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT04532424    
Other Study ID Numbers: 57738
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
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: Yes
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Asperger Syndrome
 Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders