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Behavioural Intervention

Behavioral Therapy for Tic Disorders

Phase 2
Recruiting
Led By Christine Conelea, PhD, LP
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 10-17 years at time of enrollment
Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance
Must not have
History of seizure disorder
Psychotropic medication changes in the past 6 weeks and/or plans to change medication during the study period through post-treatment assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 27 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying Tourette Syndrome and Persistent Motor/Vocal Tic Disorder in young people. These conditions can cause problems with functioning, emotions, and behavior. The main symptom is chronic tics. The

Who is the study for?
This trial is for young people with tic disorders, including Tourette Syndrome and Chronic Tic Disorder. Participants should be experiencing chronic tics that impact their daily life. The study aims to help them manage their symptoms through a treatment called CBIT.
What is being tested?
The trial tests Comprehensive Behavioral Intervention for Tics (CBIT), which teaches patients how to control tics using competing motor actions. It involves an 8-session course where the effectiveness of CBIT will be evaluated through various assessments and video recordings.
What are the potential side effects?
Since CBIT is a behavioral intervention rather than a medication, it does not have typical drug side effects. However, participants may experience fatigue or frustration during the learning process of new techniques to manage their tics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 10 and 17 years old.
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I have had motor or vocal tics for over a year without a break longer than 3 months.
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My tics are at least moderate in severity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of seizures.
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I haven't changed my mental health medication in the last 6 weeks and don't plan to change it during the study.
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I have attended at least 4 CBIT sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the Total Tic Score on the Yale Global Tic Severity Scale (YGTSS).
Secondary study objectives
Change resting-state fMRI connectivity of the brain
Components of CBIT sessions
Identify CBIT process elements that contribute to response
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CBIT groupExperimental Treatment1 Intervention
Participants with chronic TICs

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,434 Previous Clinical Trials
1,621,602 Total Patients Enrolled
4 Trials studying Tourette Syndrome
176 Patients Enrolled for Tourette Syndrome
Christine Conelea, PhD, LPPrincipal InvestigatorUniversity of Minnesota
Deanna Greene, PhDPrincipal InvestigatorUniversity of California, San Diego
~67 spots leftby Feb 2029
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