Autism Spectrum DisorderPhase 1NCT06016764
Use of MRI and cTBS for Catatonia in Autism
A Phase 1 study testing Continuous Theta Burst in Transcranial Magnetic Stimulation in people with Autism Spectrum Disorder and Catatonia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Autism Spectrum Disorder, Catatonia, Intellectual Disability
- What is being tested?
- Continuous Theta Burst in Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorder, Catatonia, Intellectual Disability
- Being tested
- Continuous Theta Burst in Transcranial Magnetic Stimulation
- Medical subject headings
- Autism Spectrum Disorder, Catatonia, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Theta Burst in Transcranial Magnetic StimulationDevice
Also called cTBS, TMS, Neuromodulation
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
| Study group | Role | What they receive |
|---|---|---|
| Individuals with a diagnosis of autism | Experimental | Individuals with an autism diagnosis Receives: Device: Continuous Theta Burst in Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
A measure of the cortical silent period duration following continuous theta burst stimulation to the primary motor strip
Measured: Obtained during TMS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start23 Aug 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt Kennedy Center
- Responsible party
- Principal investigator, Joshua Ryan Smith, MD, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016764
- Sponsor's protocol ID
- 220645
- Status last verified
- Jan 2025
- First submitted
- 23 Aug 2023
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Magnetic Resonance Imaging and Continuous Theta Burst Stimulation for Catatonia in Autism
- ClinicalTrials.gov ID
- NCT06016764
- Acronym / sponsor ID
- 220645
- Conditions
- Autism Spectrum Disorder, Catatonia, Intellectual Disability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Vanderbilt Kennedy Center
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with a diagnosis of autism | Experimental | Device: Continuous Theta Burst in Transcranial Magnetic StimulationIndividuals with an autism diagnosis |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Theta Burst in Transcranial Magnetic StimulationAlso: cTBS, TMS, NeuromodulationThis 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 | Device | Individuals with a diagnosis of autism |
Primary outcome
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.
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.
2 secondary outcomes
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.
Cortical silent period duration from transcranial magnetic stimulation
Time frame: Obtained during TMS procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Continuous Theta Burst in Transcranial Magnetic Stimulation in people with Autism Spectrum Disorder and Catatonia, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.