Use of MRI and cTBS for Catatonia in Autism

NCT06016764 | Completed Phase 1 DMC FDA Device

• 1 other identifier: 220645
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Catatonia; Intellectual Disability

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (2)

• 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.

• Cortical silent period duration from transcranial magnetic stimulation

  Obtained during TMS procedure

Other Outcomes (3)

• Vineland Adaptive Behavior Scale

  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

  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.

  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.

Study Arms (1)

Individuals with a diagnosis of autism

EXPERIMENTAL

Individuals with an autism diagnosis

Device: Continuous Theta Burst in Transcranial Magnetic Stimulation

Interventions

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

Also known as: cTBS, TMS, Neuromodulation

Individuals with a diagnosis of autism

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Expresses dissenting behaviors as outlined below.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Vanderbilt Kennedy Center: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Catatonia; Intellectual Disability

Interventions

Transcranial Magnetic Stimulation; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 30, 2023
• Study Start: August 23, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

US (1)