Using Transcranial Magnetic Stimulation to Treat Repetitive Behaviors in Autism
Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
This study is testing if a non-invasive brain treatment can help reduce repetitive behaviors in people with Autism Spectrum Disorder who haven't had success with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 67 (estimated) |
| Ages | 12 Years to 45 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT04532424 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 12 to 45 with a diagnosis of Autism Spectrum Disorder who have not responded to or tolerated two prior treatments.
Not a fit: Patients with contraindications for TMS, such as a history of seizures or significant sensory impairments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce repetitive behaviors in individuals with Autism Spectrum Disorder, enhancing their daily functioning and quality of life.
How similar studies have performed: While the use of TMS in treating various conditions is being explored, this specific application for restricted and repetitive behaviors in ASD is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Stanford, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.