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New treatment option for Tourette Syndrome
Official title Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics
ClinicalTrials.gov ID: NCT06194305
What this study is testing
- What it's testing
- Tourette Syndrome and Persistent Motor/Vocal Tic Disorder affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17
You may be able to join if
- 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...
- At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only).
- Full scale IQ greater than 70.
- Child participant required to have English fluency to ensure comprehension of study measures and instructions.
You likely can't join if
- Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG.
- Active suicidality Previous diagnosis of psychosis, cognitive disability, or structural brain disease that in the investigator opinion would impede...
- History of seizure disorder
- Active substance abuse or dependence.
- Presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be...
- Concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting...
See the full eligibility criteria
- 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...
- At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only).
- Full scale IQ greater than 70.
- Child participant required to have English fluency to ensure comprehension of study measures and instructions.
- To increase external validity of findings, we will include participants taking psychotropic medications that have been stable for 4 weeks and expect to remain stable for the study period. Individuals receiving non-tic...
- Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG.
- Active suicidality Previous diagnosis of psychosis, cognitive disability, or structural brain disease that in the investigator opinion would impede participation.
- History of seizure disorder
- Active substance abuse or dependence.
- Presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for...
- Concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
- Psychotropic medication changes in the past 4 weeks and/or plans to change medication during the study period through post-treatment assessment.
- ≥ 4 previous sessions of CBIT.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.