Status:
COMPLETED
Use of MRI and cTBS for Catatonia in Autism
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Vanderbilt Kennedy Center
Conditions:
Autism Spectrum Disorder
Catatonia
Eligibility:
All Genders
15-40 years
Phase:
PHASE1
Brief Summary
Despite the significant morbidity and mortality associated with catatonia in autism, no diagnostic research has attempted to identify biomarkers for catatonia. This application will use a participant'...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Individuals aged 15-40 years of age will be enrolled. This age range was selected given the high degree of social development occurring in this life stage, the developmental nature of ASD, and ongoing cTBS-induced changes in MEP amplitude observed in AIC individuals as they age.
- Subjects and/or guardians must also be fluent in English, diagnosed with ASD based on DSM-5 criteria1 and Autism Diagnostic Observation Schedule-II (ADOS-II) assessment,78 and competent to assent to the study based on investigator clinical evaluation. Consenting guardians will be included if indicated.
- Subjects, or guardians if subjects cannot consent, must be competent to consent to the study. Subjects must be able to assent to the study as determined by clinical evaluation from the primary investigator.
- Exclusion Criteria:
- History of substance abuse/dependence,
- History of concomitant major medical/neurologic illness
- History of seizure within one calendar year
- History of traumatic brain injury
- Pregnant or currently breastfeeding
- Are psychiatrically or medically unstable as determined by the investigator clinical evaluation
- Prescribed medication contraindicated in TMS
- Have a history of TMS treatment.
- Are diagnosed with a syndrome which results in ASD symptoms as preliminary research suggests individuals with these diagnoses have differing biomarker responses to TMS.26
- 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.
- MRI scanning also introduces exclusionary criteria for conditions contraindicated to MRI, thus individuals with any bodily metal, history of claustrophobia, or pacemakers will be excluded.
- Expresses dissenting behaviors as outlined below.
Exclusion
Key Trial Info
Start Date :
August 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06016764
Start Date
August 23 2023
End Date
December 1 2025
Last Update
December 31 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212