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Procedure

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

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

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 15 and 40 years old.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bush Francis catatonia rating scale

The change in motor evoked potentials elicited from transcranial magnetic stimulation

Secondary outcome measures

Cortical silent period duration from transcranial magnetic stimulation

Social responsiveness scale, 2nd edition

Other outcome measures

Intelligence quotient as measured by Leiter International Performance Scale, third edition.

Intelligence quotient as measured by the Wechsler Abbreviated Scale of Intelligence, 2nd edition

Vineland Adaptive Behavior Scale

Trial Design

1Treatment groups

Experimental Treatment

Group I: Individuals with a diagnosis of autismExperimental Treatment1 Intervention

Individuals with an autism diagnosis

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt Kennedy CenterOTHER

2 Previous Clinical Trials

120 Total Patients Enrolled

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,153 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to enroll in this research trial?

"Eligibility for this trial is restricted to those with autism spectrum disorder and aged 15-40. The maximum enrolment of participants is 40 individuals."

Answered by AI

What danger does this treatment pose to individuals who receive it?

"This experimental intervention has only undergone preliminary safety testing, so the assessment of its security was rated a 1."

Answered by AI

Are there any vacancies available in this research project?

"Clinicaltrials.gov lists this trial as ongoing, with the original post date being 23rd August 2023 and the latest edits occurring on same day."

Answered by AI

Are persons aged 45 and under admissible for this investigation?

"To be included in this clinical trial, participants must be between the ages of 15 and 40. There are 264 studies available to people younger than 18 while 49 trials exist for those aged 65 or above."

Answered by AI

How many people have enrolled in this medical experiment thus far?

"Affirmative. Via clinicaltrials.gov, data shows that this research is still actively recruiting participants who meet the criteria. The original posting of the study was on 8/23/2023 and it's been updated since then; 40 patients are needed at one site for completion of the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of MRI and cTBS for Catatonia in Autism

Joshua Ryan Smith, MD 2023. "Use of MRI and cTBS for Catatonia in Autism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06016764.