NCT04532424 Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
| NCT ID | NCT04532424 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 67 participants |
| Start Date | 2021-01-04 |
| Primary Completion | 2029-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 67 participants in total. It began in 2021-01-04 with a primary completion date of 2029-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.
Eligibility Criteria
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).
Contact & Investigator
Antonio Y. Hardan, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT04532424 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 45 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04532424 currently recruiting?
Yes, NCT04532424 is actively recruiting participants. Contact the research team at autismdd@stanford.edu for enrollment information.
Where is the NCT04532424 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT04532424 clinical trial?
NCT04532424 is sponsored by Stanford University. The principal investigator is Antonio Y. Hardan, MD at Stanford University. The trial plans to enroll 67 participants.