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| Name | Class |
|---|---|
| Vanderbilt Kennedy Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with a diagnosis of autism | Experimental | Individuals with an autism diagnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Theta Burst in Transcranial Magnetic Stimulation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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.
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.
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.
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002389 | Catatonia |
| D008607 | Intellectual Disability |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
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| 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 | Obtained during TMS procedure |
| 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 | 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. | 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. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |