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Recruiting

NCT Number: NCT04532424

Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

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

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Key information

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305-5719, United States

Location status: Recruiting

Location contact

Ryan Villacrucis

CONTACT

[email protected]

(650) 736-1235

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

.

  • Diagnosis of Autism Spectrum Disorder (ASD)
  • Meet criteria for Autism Spectrum Disorder (ASD) on clinical assessments (ADOS-2 or CARS if conducted remotely & ADI-R)
  • Aged between 12-45 years old
  • Have a reliable informant who can complete relevant questionnaires
  • 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

.

  • 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.
  • 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.
  • Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation).
  • Not willing to cooperate with the TMS procedures.
  • 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.
  • Conditions that increase the risk for COVID-19 (in accordance with university guidelines).

Treatment and study plan

Transcranial Magnetic Stimulation

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Briana Hernandez

CONTACT

[email protected]

(650) 736-1235

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: TMS for ASD

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Aug 31, 2020
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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