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Search / Trial NCT04532424

Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

Launched by STANFORD UNIVERSITY · Aug 26, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called transcranial magnetic stimulation (TMS) that uses a method called theta-burst stimulation to help reduce restricted and repetitive behaviors in individuals with Autism Spectrum Disorder (ASD), including those with Asperger's syndrome. The trial is currently looking for participants aged between 12 and 45 who have been diagnosed with ASD and have not responded well to at least two previous treatments. To take part, individuals will need someone, like a family member or caregiver, who can help answer some questions about their behavior.

If eligible, participants can expect to receive TMS treatment in a safe and supportive environment. However, there are certain health conditions that would prevent someone from joining, including a history of seizures, pregnancy, or severe insomnia. It's important to note that this trial is focused on individuals who have struggled with other treatment options and are looking for new ways to manage their symptoms. Overall, the goal is to better understand how this innovative approach might help improve daily life for those with ASD.

Gender

ALL

Eligibility criteria

  • 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.

About Stanford University

Stanford University is a prestigious academic institution renowned for its cutting-edge research and innovation in healthcare and medicine. As a clinical trial sponsor, Stanford leverages its extensive resources, including a collaborative network of world-class researchers and state-of-the-art facilities, to advance medical knowledge and improve patient care. The university is committed to conducting rigorous, ethical research that adheres to the highest standards of scientific integrity, fostering an environment where groundbreaking discoveries can translate into effective clinical applications. Through its clinical trials, Stanford aims to address critical health challenges and contribute to the development of novel therapies and treatment strategies.

Locations

Stanford, California, United States

Stanford, California, United States

Patients applied

0 patients applied

Trial Officials

Antonio Y. Hardan, MD

Principal Investigator

Stanford University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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