Recruiting

Transcranial Magnetic Stimulation

Sponsor:

Stanford University

Code:

NCT04532424

Conditions

Autism Spectrum Disorder

Autism

Asperger Syndrome

Eligibility Criteria

Sex: All

Age: 12 - 45

Healthy Volunteers: Not accepted

Interventions

Transcranial magnetic stimulation

Study Details

Brief summary:

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

Conditions

Autism Spectrum Disorder

Autism

Asperger Syndrome

Study ID

NCT04532424

Start date

Jan 4, 2021

Status verified date

Aug, 2025

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Dec 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 45

Healthy Volunteers: Not accepted

Inclusion criteria.

1. Diagnosis of Autism Spectrum Disorder (ASD)
2. Meet criteria for Autism Spectrum Disorder (ASD) on clinical assessments (ADOS-2 or CARS if conducted remotely \& ADI-R)
3. Aged between 12-45 years old
4. Have a reliable informant who can complete relevant questionnaires
5. Have DARB scores which indicate high levels (50% or above) of RRB on one of the following domains: Insistence on Sameness, Obsessive Compulsive Behaviors, and Unusual Interests

Exclusion criteria.

1. Any contraindications for TMS e.g. history of seizures other than clear substance-induced/fever-induced seizures with neurologist note or normal clean EEG and no seizure in at least 12 months prior to enrollment.
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. Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation).
9. Not willing to cooperate with the TMS procedures.
10. Currently taking Clozapine or another medication that the PI determines increases the risk of TMS or may disrupt the efficacy.
11. A motor threshold that is too high to allow safe/tolerable treatment.
12. Conditions that increase the risk for COVID-19 (in accordance with university guidelines).

Study Design

Enrollment

67 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Targeting insistence on sameness

experimental: Targeting stereotyped motor behaviors

Interventions

Transcranial magnetic stimulation

Non-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine.

Primary outcome measure

  • Repetitive Behavior Scale-Revised (RBS-R) [ Time Frame: Up to one month post-treatment ]

Central Contacts and Locations

Central contacts

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305-5719

Contacts

More Information

Sponsor

Stanford University

Last update posted

Aug 19, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2025-08-19.