Using Transcranial Magnetic Stimulation to Treat Repetitive Behaviors in Autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of theta-burst transcranial magnetic stimulation (TMS) in reducing restricted and repetitive behaviors in individuals diagnosed with Autism Spectrum Disorder (ASD), including Asperger's Syndrome. Participants aged 12 to 45 who have not responded to or tolerated two previous treatments will undergo TMS sessions. The study aims to assess changes in behavior through clinical assessments and questionnaires completed by reliable informants. The approach focuses on a non-invasive method to potentially improve the quality of life for those affected by ASD.

Why it matters

Who can join: the full rules

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).

Where it's running

• Stanford University
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Antonio Y. Hardan, MD — Stanford University
• Study coordinator: Briana Hernandez
• Email: autismdd@stanford.edu
• Phone: (650) 736-1235

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.