Use of MRI and cTBS for Catatonia in Autism

Vanderbilt University Medical Center

Status and phase

Completed

Phase 1

Conditions

Autism Spectrum Disorder

Catatonia

Intellectual Disability

Treatments

Device: Continuous Theta Burst in Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06016764

220645

Details and patient eligibility

About

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's own individual brain magnetic resonance image to target the primary motor strip with transcranial magnetic stimulation; to determine if hyper-excitability of the brain directly correlates with symptoms of catatonia and social-emotional impairment in autism. Completion of this project would result in the first study to associate hyper-excitability of the brain with catatonia and core features of autism; findings which are likely to have a significant impact on the health and well-being of autistic individuals.

Enrollment

26 patients

Sex

All

Ages

15 to 40 years old

Volunteers

No Healthy Volunteers

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.