Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

Study Overview
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Brief Summary
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Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.

Official Title
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Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

Conditions
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Autism Spectrum Disorder, Autism, Asperger Syndrome

Intervention / Treatment
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* Device: Transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Autism Spectrum Disorder (ASD), Asperger's or Autism. Meet criteria for ASD on clinical assessments (ADOS-2 or CARS/BOSA if conducted remotely & ADI-R) Aged between 12-45 years old Have a reliable informant who can complete relevant questionnaires Must have previously not responded or not tolerated 2 treatments. Exclusion Criteria: Any contraindications for TMS e.g. history of seizures Pregnancy 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. Active substance use (<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines Showing symptoms of withdrawal from alcohol or benzodiazepines DSM-5 diagnosis of bipolar disorder or a psychotic disorder e.g. schizophrenia. Significant sensory impairments such as blindness or deafness. Any other indication the PI feels would comprise data Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation) IQ<50 or not testable using IQ measures and no historical IQ score available Currently taking Clozapine or another medication that the PI determines increases the risk of TMS or may disrupt the efficacy. A motor threshold that is too high to allow safe/tolerable treatment.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to one of 2 groups based on the presentation of restricted and repetitive behavior.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeting insistence on sameness<br> | Device: Transcranial magnetic stimulation<br>* Non-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine.<br>|
| Experimental: Targeting stereotyped motor behaviors<br> | Device: Transcranial magnetic stimulation<br>* Non-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repetitive Behavior Scale-Revised (RBS-R) | 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. | Up to one month post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Set-shifting performance (Dimensional Change Card Sort Test score) | 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. | Baseline & immediately after treatment |