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

February 6, 2024 updated by: Antonio Hardan, Stanford University
Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-5719
        • Robin Libove

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to one month post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline & immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Antonio Y. Hardan, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2021

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-57738

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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