NCT06016764CompletedPhase 1
Use of MRI and cTBS for Catatonia in Autism
Use of Magnetic Resonance Imaging and Continuous Theta Burst Stimulation for Catatonia in Autism
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 23 Aug 2023
- Start date
- 23 Aug 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Autism
- NCT number
- NCT06016764
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 26
- From 23 Aug 2023 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of concomitant major medical/neurologic illness
- Prescribed medication contraindicated in TMS
Other illness
- History of substance abuse/dependence,
- History of seizure within one calendar year
- History of traumatic brain injury
- 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
- 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.
Age
- 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.
Other
- Pregnant or currently breastfeeding
- Are psychiatrically or medically unstable as determined by the investigator clinical evaluation
- Expresses dissenting behaviors as outlined below.
Who the study is looking for
- 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.
Age in the registry: 15 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.