Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2023-08-23
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Individuals with a diagnosis of autism
Individuals with an autism diagnosis
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
15 Years
40 Years
ALL
No
Sponsors
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Vanderbilt Kennedy Center
OTHER
Vanderbilt University Medical Center
OTHER
Responsible Party
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Joshua Ryan Smith, MD
Assistant Professor of Psychiatry and Behavioral Sciences
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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220645
Identifier Type: -
Identifier Source: org_study_id