Use of MRI and CTBS for Catatonia in Autism

Phase 1

Recruiting

• Conditions: Autism Spectrum Disorder; Catatonia; Intellectual Disability
• Interventions: Device: Continuous Theta Burst in Transcranial Magnetic Stimulation

• Registration Number: NCT06016764
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-23
• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-08-23
• Study Completion: 2026-08-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Individuals with a diagnosis of autism	Continuous Theta Burst in Transcranial Magnetic Stimulation	Individuals with an autism diagnosis

Primary Outcome Measures

Name	Time	Method
Bush Francis catatonia rating scale	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.	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.
The change in motor evoked potentials elicited from transcranial magnetic stimulation	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.	Three batches of 10 MEPs will be recorded before cTBS and used as a baseline measure of motor evoked potentials.

Secondary Outcome Measures

Name	Time	Method
Cortical silent period duration from transcranial magnetic stimulation	Obtained during TMS procedure	A measure of the cortical silent period duration following continuous theta burst stimulation to the primary motor strip
Social responsiveness scale, 2nd edition	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.	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States