Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

Not Applicable

Suspended

• Conditions: Asperger Syndrome; Autism Spectrum Disorder; Autism
• Interventions: Device: Transcranial magnetic stimulation

• Registration Number: NCT04532424
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Study Start: 2021-01-04
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 67

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Targeting insistence on sameness	Transcranial magnetic stimulation	-
Targeting stereotyped motor behaviors	Transcranial magnetic stimulation	-

Primary Outcome Measures

Name	Time	Method
Repetitive Behavior Scale-Revised (RBS-R)	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

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

Trial Locations

Locations (1)

Robin Libove; 🇺🇸 Stanford, California, United States