BridgeMD
New treatment option for Tics
Official title CBIT+TMS R33 Phase
ClinicalTrials.gov ID: NCT06678737
What this study is testing
- What it's testing
- Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth 1 and are associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, peer victimization, and a fourfold increased risk of suicide compared to the general population.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 21
You may be able to join if
- Age 12-21 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, consenting parent, and adult participant required to have English fluency and literacy to ensure comprehension of study measures and...
You likely can't join if
- Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure...
- Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia)
- Active suicidality.
- Previous diagnosis of psychosis or cognitive disability.
- Substance abuse or dependence within the past year.
- Concurrent psychotherapy focused on tics.
See the full eligibility criteria
- Age 12-21 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, consenting parent, and adult participant required to have English fluency and literacy 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 6 weeks and expect to remain stable for the approximately 3-week intervention protocol...
- Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, implanted medical...
- Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia)
- Active suicidality.
- Previous diagnosis of psychosis or cognitive disability.
- Substance abuse or dependence within the past year.
- Concurrent psychotherapy focused on tics.
- Neuroleptic/antipsychotic medications.
- Pregnant according to the medical history or a urine pregnancy test; and menstruating individuals capable of becoming pregnant and not using a highly effective form of contraception (FDA-approved hormonal contraceptive...
- Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)
The study team makes the final eligibility decision.
Where it's taking place
- 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, 12 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.