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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

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:

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.

Sites / Locations

Robin Libove

Arms of the Study

Arm 1

Arm 2

Arm Type

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

NCT ID

NCT04532424

First Posted

August 21, 2020

Last Updated

March 2, 2023

Sponsor

Stanford University

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

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

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

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

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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