Clinical trial NCT06016764: Use of MRI and CTBS for Catatonia in Autism
Official title: Use of Magnetic Resonance Imaging and Continuous Theta Burst Stimulation for Catatonia in Autism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Autism Spectrum Disorder
Catatonia
Intellectual Disability
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Vanderbilt Kennedy Center
First posted: 2023-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change in motor evoked potentials elicited from transcranial magnetic stimulation
timeFrame: 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.
measure: Bush Francis catatonia rating scale
timeFrame: 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.
Secondary outcomes:
measure: Social responsiveness scale, 2nd edition
timeFrame: 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: Cortical silent period duration from transcranial magnetic stimulation
timeFrame: Obtained during TMS procedure
Other outcomes:
measure: Vineland Adaptive Behavior Scale
timeFrame: 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.
measure: Intelligence quotient as measured by the Wechsler Abbreviated Scale of Intelligence, 2nd edition
timeFrame: 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.
measure: Intelligence quotient as measured by Leiter International Performance Scale, third edition.
timeFrame: 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.
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: