A Phase 1 interventional study of Continuous Theta Burst in Transcranial Magnetic Stimulation in Autism Spectrum Disorder, Catatonia and Intellectual Disability, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Vanderbilt University Medical Center · Phase 1, Interventional, and Diagnostic
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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's enrollment of 26 is below the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with an autism diagnosis
Device: Continuous Theta Burst in Transcranial Magnetic Stimulation
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, intellectual disability, and social-emotional impairment in autism
Also known as: cTBS, TMS, Neuromodulation
The change in motor evoked potentials elicited from transcranial magnetic stimulation
Three batches of 10 MEPs will be recorded before cTBS and used as a baseline measure of motor evoked potentials.
Time frame: 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.
Bush Francis catatonia rating scale
A systematic and standardized physical examination to assess for catatonic symptomology. The minimum score is 0, a positive screen is a score is greater than or equal to 2, and the maximum score is 69. A higher score is associated with more significant catatonic symptomology.
Time frame: This examination will be performed twice over the study period. The first examination will occur at the initial visit (baseline). The second examination will occur prior to the TMS procedure. There will be no follow up examination after study completion.
Social responsiveness scale, 2nd edition
An assessment of social and emotional relatedness for individuals with autism. Two scores will be obtained, one from the participant and another from a parent or close informant. A minimum score is 0, a maximum score is 195, and a higher score is associated with greater social emotional impairment in autism.
Time frame: Administered at the second research visit along with psychological testing. The second research session will include additional baseline testing. This test will be done before the TMS procedure is performed. It will not be repeated.
Cortical silent period duration from transcranial magnetic stimulation
A measure of the cortical silent period duration following continuous theta burst stimulation to the primary motor strip
Time frame: Obtained during TMS procedure
Vineland Adaptive Behavior Scale
A measure of adaptive functioning for individuals with developmental disabilities and/or intellectual disability. The standard scoring range is 20 - 140, with lower scores indicating a lower level of adaptive functioning.
Time frame: 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.
Intelligence quotient as measured by the Wechsler Abbreviated Scale of Intelligence, 2nd edition
A measure of cognitive abilities via standardized testing. High scores indicated a high level of cognitive functioning and lower scores indicate a greater degree of cognitive impairment. The Wechsler Abbreviated Scale of Intelligence, 2nd edition would be used for verbal patients. The range of composite scores are 40 - 160
Time frame: 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.
Intelligence quotient as measured by Leiter International Performance Scale, third edition.
A measure of cognitive abilities via standardized testing. High scores indicated a high level of cognitive functioning and lower scores indicate a greater degree of cognitive impairment. The Leiter International Performance Scale, third edition would be used for non-speaking patients. The range of composite scores are 30 - 170.
Time frame: 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.
Plan to share: Yes — As the Principal Investigator of this study, I will comply with the NIH policy on the Dissemination of NIH-Funded Clinical Trial Information. The proposed study has been registered with ClinicalTrials.gov (NCT06016764). We will update our current informed consent/assent documents to reflect the information on ClinicalTrials.gov. Vanderbilt University Medical Center has internal policies in place to ensure clinical trial registration and reporting in compliance with poly requirements. We also intend to publish our results in peer-reviewed journals and present our data at conferences nationally and internationally.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Within one year after the completion of all components of the study, we will make de-identified data available via the NIH Data Archive for the purposes of research, improvement of clinical care, or education of the public, or qualified individuals within the scientific community.
Access criteria: To maximize the appropriate sharing of scientific data and project research participants' privacy and confidentiality, the reuse of this dataset should use the following Data Use Limitations (DULs) under Controlled Access that is made available by a data repository only after approval. The data set can only be used for studying health, medical, or biomedical conditions and does not include the study of population origins or ancestry. The requesting institutional review board or equivalent body must approve the requested use.
No publications or documents are linked to this record.
Ran from Aug 2023 to primary completion in Dec 2025, 27 months.
Of 35 phase 1 interventional studies under Autism Spectrum Disorder, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 27. This study's 27 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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