MRI + cTBS for Catatonia in Autism

Phase 1

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals aged 15-40 years of age will be enrolled

Be younger than 65 years old

Must not have

Children below the age of fifteen will also be excluded because of decreased likelihood of remaining still in the MRI scanner, as well as for scientific reasons surrounding unknown variability for key variables during pubertal onset

History of seizure within one calendar year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up performed during psychological assessment, 2nd research appointment. the second research session will include additional baseline testing. this test will only be performed once and will not be repeated after the study is complete.

Awards & highlights

No Placebo-Only Group

Summary

This trial will use brain imaging to see if over-activity in the brain is linked to catatonia and autism, to help improve the lives of those with autism.

Who is the study for?

This trial is for individuals aged 15-40 with Autism Spectrum Disorder (ASD), diagnosed by DSM-5 criteria and ADOS-II assessment. Participants must understand English, be able to give consent or have a guardian who can, and be medically stable. Exclusions include substance abuse history, major medical issues, seizures within the last year, pregnancy/breastfeeding, metal in body/pacemakers/claustraphobia that affect MRI safety.

What is being tested?

The study aims to find biomarkers for catatonia in autism using individual brain MRIs to guide transcranial magnetic stimulation (cTBS) targeting the motor strip. It will explore if brain hyper-excitability correlates with catatonia symptoms and social-emotional impairment in autistic individuals.

What are the potential side effects?

Potential side effects of cTBS may include discomfort at the stimulation site, headache, lightheadedness or seizures; however specific risks related to this trial are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 15 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am 15 years or older.

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I have had a seizure in the past year.

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My medication is not safe with TMS treatment.

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I have undergone TMS therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ following the application of ctbs, batches of 10 meps will be measured every 20 minutes for a total of 120 minutes. ∆mep amplitude will be calculated at each 20 minute interval.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~following the application of ctbs, batches of 10 meps will be measured every 20 minutes for a total of 120 minutes. ∆mep amplitude will be calculated at each 20 minute interval.

This trial's timeline: 3 weeks for screening, Varies for treatment, and following the application of ctbs, batches of 10 meps will be measured every 20 minutes for a total of 120 minutes. ∆mep amplitude will be calculated at each 20 minute interval. for reporting.