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Behavioral Intervention

TMS + Behavior Therapy for Tourette Syndrome

N/A
Waitlist Available
Led By Christine Conelea, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3-4 months
Awards & highlights

Study Summary

This trial will test whether a treatment combining CBIT and TMS can improve tic suppression ability and CBIT outcomes in young people with tic disorder.

Who is the study for?
This trial is for young people with moderate to severe tic disorders, including Tourette Syndrome. Participants must be right-handed, have an IQ of 70 or above, and speak English fluently. They should not have had a tic-free period longer than three months in the past year. Those with psychosis, cognitive disabilities, unstable medication regimens, substance abuse issues, certain medical conditions like epilepsy or brain injuries, or who are pregnant without contraception are excluded.Check my eligibility
What is being tested?
The study tests if combining Behavioral Therapy (CBIT) with Transcranial Magnetic Stimulation (TMS), specifically targeting the supplementary motor area (SMA), can improve control over tics in individuals with Tic Disorders. It will also explore different dosing strategies of TMS to see which is most effective.See study design
What are the potential side effects?
Transcranial Magnetic Stimulation may cause discomfort at the stimulation site, headache, lightheadedness or seizures very rarely. The behavioral therapy involved does not typically result in physical side effects but may involve emotional discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3-4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3-4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in SMA activation
Change in resting state fMRI connectivity of SMA-mediated brain circuits
Secondary outcome measures
Change in Tic Suppression Task
Feasibility: Measured as Participant Treatment Completion
Safety: Measured as Rate of Adverse Events Related to Study Treatment

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: CBIT + rTMSActive Control2 Interventions
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
Group II: CBIT + cTBSActive Control2 Interventions
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
Group III: CBIT + ShamPlacebo Group1 Intervention
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,377 Previous Clinical Trials
1,588,240 Total Patients Enrolled
2 Trials studying Tourette Syndrome
130 Patients Enrolled for Tourette Syndrome
Christine Conelea, PhDPrincipal InvestigatorUniversity of Minnesota
3 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Tourette Syndrome
30 Patients Enrolled for Tourette Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I qualify for inclusion in this research endeavor?

"The study necessitates that participants have tourette syndrome and an age between 12-21. Approximately 60 individuals will be admitted to the trial."

Answered by AI

How many participants are included in this investigation?

"Affirmative. The information posted to clinicaltrials.gov demonstrates that the study, which was first uploaded on November 1st 2020, is actively seeking enrollees. Approximately 60 subjects are expected from a single medical centre."

Answered by AI

Is recruitment currently still underway for this experiment?

"According to the clinicaltrials.gov listing, this medical trial is open and actively recruiting patients. The first post was made on November 1st 2020 and updated most recently in June 15th 2022."

Answered by AI

Are adults of legal age being included in the trial's recruitment?

"This trial is reaching out to minors aged 12-21 who would like to take part."

Answered by AI
~13 spots leftby Apr 2025