Asperger Syndrome, Autism, Autism Spectrum Disorder
Conditions
Brief summary
Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.
Interventions
DEVICETranscranial magnetic stimulation
Non-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be assigned to one of 2 groups based on the presentation of restricted and repetitive behavior.
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Repetitive Behavior Scale-Revised (RBS-R) | 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
| Measure | Time frame | Description |
|---|---|---|
| Set-shifting performance (Dimensional Change Card Sort Test score) | 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. |
Countries
United States
Contacts
Primary ContactBriana Hernandez
Outcome results
None listed