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Use of MRI and cTBS for Catatonia in Autism

Primary Purpose

Autism Spectrum Disorder, Catatonia

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Continuous Theta Burst in Transcranial Magnetic Stimulation
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autism Spectrum Disorder

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.26,75-77 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.

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2023
Last Updated
August 23, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
Vanderbilt Kennedy Center
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1. Study Identification

Unique Protocol Identification Number
NCT06016764
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
August 23, 2025 (Anticipated)
Study Completion Date
August 23, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Vanderbilt Kennedy Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Catatonia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Continuous Theta Burst in Transcranial Magnetic Stimulation
Other Intervention Name(s)
cTBS, TMS, Neuromodulation
Intervention Description
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
Primary Outcome Measure Information:
Title
The change in motor evoked potentials elicited from transcranial magnetic stimulation
Description
Three batches of 10 MEPs will be recorded before cTBS and used as a baseline measure of motor evoked potentials.
Time Frame
After cTBS, batches of 10 MEPs will be measured every 20 minutes for a total of 120 minutes to track ∆MEP amplitude over time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.26,75-77 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua R Smith
Phone
6159363555
Email
Joshua.R.Smith@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Mahler, MS
Phone
6159363555
Email
sarah.marler@vumc.org
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua R Smith, MD
Phone
615-936-3555
Email
Joshua.R.Smith@vumc.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Use of MRI and cTBS for Catatonia in Autism

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