Use of MRI and cTBS for Catatonia in Autism

December 26, 2025 updated by: Joshua Ryan Smith, MD, Vanderbilt University Medical Center

Use of Magnetic Resonance Imaging and Continuous Theta Burst Stimulation for Catatonia in Autism

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Individuals with a diagnosis of autism
Individuals with an autism diagnosis
Device: 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 Names:
  • TMS
  • Neuromodulation
  • cTBS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change in motor evoked potentials elicited from transcranial magnetic stimulation
Time Frame: 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.
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
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Social responsiveness scale, 2nd edition
Time Frame: 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.
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
Time Frame: Obtained during TMS procedure
A measure of the cortical silent period duration following continuous theta burst stimulation to the primary motor strip
Obtained during TMS procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vineland Adaptive Behavior Scale
Time Frame: 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.
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.
Intelligence quotient as measured by the Wechsler Abbreviated Scale of Intelligence, 2nd edition
Time Frame: 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.
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.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vanderbilt Kennedy Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 220645

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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