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Combined CBIT and rTMS to Improve Tourette's Syndrome

NCT04795908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-04-30

Study results available
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Summary

The investigator will apply 16 sessions of repetitive transcranial magnetic stimulation (rTMS) over 4 consecutive days for adult patients suffering from Tourette's Syndrome. Following rTMS, patients will undergo 8 sessions of Comprehensive Behavioral Intervention for Tics (CBIT) over 10 weeks via telemedicine. Clinical improvement in tic severity will be the primary outcome measure. Secondary outcome measures including underlying physiological effects will be measured via functional magnetic resonance imaginge (fMRI), high-density electroencephalograhy (HD-EEG), and TMS.

Conditions

  • Tourette Syndrome

Interventions

DEVICE

Transcranial Magnetic Stimulation

rTMS will be delivered using a MagStim Super Rapid2 TMS therapy system.

BEHAVIORAL

Comprehensive behavioral intervention

Patients will receive CBIT with a therapist trained in CBIT. Each session will last about an hour and will be delivered remotely via telemedicine. Sessions will be tailed to the patient's individual needs.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Aparna Wagle Shukla, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-17
Primary Completion
2023-01-18
Completion
2023-01-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04795908 on ClinicalTrials.gov