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

Primary Purpose

Autism Spectrum Disorder, Autism, Asperger Syndrome

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Robin Libove

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Targeting insistence on sameness

Targeting stereotyped motor behaviors

Arm Description

Outcomes

Primary Outcome Measures

Repetitive Behavior Scale-Revised (RBS-R)
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

Set-shifting performance (Dimensional Change Card Sort Test score)
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.

Full Information

First Posted
August 21, 2020
Last Updated
March 2, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04532424
Brief Title
Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
Acronym
TMS for ASD
Official Title
Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Suspended
Why Stopped
Recruitment is currently suspended due to a change in PI and staff training is required.
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism, Asperger Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to one of 2 groups based on the presentation of restricted and repetitive behavior.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Targeting insistence on sameness
Arm Type
Experimental
Arm Title
Targeting stereotyped motor behaviors
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
Non-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine.
Primary Outcome Measure Information:
Title
Repetitive Behavior Scale-Revised (RBS-R)
Description
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.
Time Frame
Up to one month post-treatment
Secondary Outcome Measure Information:
Title
Set-shifting performance (Dimensional Change Card Sort Test score)
Description
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.
Time Frame
Baseline & immediately after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Autism Spectrum Disorder (ASD), Asperger's or Autism. Meet criteria for ASD on clinical assessments (ADOS-2 or CARS/BOSA if conducted remotely & ADI-R) Aged between 12-45 years old Have a reliable informant who can complete relevant questionnaires Must have previously not responded or not tolerated 2 treatments. Exclusion Criteria: Any contraindications for TMS e.g. history of seizures Pregnancy 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. Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines Showing symptoms of withdrawal from alcohol or benzodiazepines DSM-5 diagnosis of bipolar disorder or a psychotic disorder e.g. schizophrenia. Significant sensory impairments such as blindness or deafness. Any other indication the PI feels would comprise data Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation) IQ<50 or not testable using IQ measures and no historical IQ score available Currently taking Clozapine or another medication that the PI determines increases the risk of TMS or may disrupt the efficacy. A motor threshold that is too high to allow safe/tolerable treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Y. Hardan, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robin Libove
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5719
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30038561
Citation
Barahona-Correa JB, Velosa A, Chainho A, Lopes R, Oliveira-Maia AJ. Repetitive Transcranial Magnetic Stimulation for Treatment of Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Front Integr Neurosci. 2018 Jul 9;12:27. doi: 10.3389/fnint.2018.00027. eCollection 2018.
Results Reference
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PubMed Identifier
24127165
Citation
Oberman LM, Rotenberg A, Pascual-Leone A. Use of transcranial magnetic stimulation in autism spectrum disorders. J Autism Dev Disord. 2015 Feb;45(2):524-36. doi: 10.1007/s10803-013-1960-2.
Results Reference
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Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

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