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NCT06678737 · ClinicalTrials.gov registry record · Phase 2

CBIT+TMS R33 Phase

A Phase 2 study of Tourette Syndrome and Tics, sponsored by University of Minnesota.

Recruiting
Registry status
Phase 2
Development phase
60
Enrollment target
1
Study location

NCT06678737 is a Phase 2 study of Tourette Syndrome and Tics that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 60 participants, below the 85-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (29% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06678737, a Phase 2 study of Tourette Syndrome and Tics, is actively recruiting participants, sponsored by University of Minnesota.

RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

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. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients. However, in these trials, only 52% of children and 38% of adults showed clinically meaningful tic improvement, meaning that 50-60% of patients do not benefit from CBIT. CBIT success relies on an ability to suppress tics that many youth lack. The central aim of CBIT is to enhance voluntary tic suppression. Better tic suppression ability drives CBIT improvement 10 and predicts lower tic burden over the course of illness. During the core CBIT procedure, competing response training, patients learn to inhibit tics by engaging in a competing motor action. However, research shows that many youth lack this fundamental tic suppression ability that CBIT aspires to enhance. This study will examine the clinical and neural effects of a treatment combining Comprehensive Behavioral Intervention for Tics (CBIT) and transcranial magnetic stimulation (TMS) to the supplementary motor area (SMA) in young people with tic disorder.

Conditions Studied

Interventions

  • OTHER CBIT +cTBS
  • OTHER CBIT +sham cTBS

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-02-27
Est. Completion 2030-07-15
Phase Phase 2

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT06678737

The ClinicalTrials.gov registry entry for NCT06678737 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 85-participant average among 33 other Tourette Syndrome trials with a reported enrollment target (29% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Tourette Syndrome appearing as the primary indexed condition, and to 2 interventions - of which CBIT +cTBS is the first listed.

NCT06678737 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT06678737 about?

NCT06678737 is a clinical study titled "CBIT+TMS R33 Phase". 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 fourf...

What is the current status of trial NCT06678737?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-02-27. Estimated completion is 2030-07-15.

What conditions does trial NCT06678737 study?

This clinical trial studies the following conditions: Tourette Syndrome, Tics.

What interventions are being tested in trial NCT06678737?

The interventions under investigation include: CBIT +cTBS (OTHER), CBIT +sham cTBS (OTHER).

Who is sponsoring clinical trial NCT06678737?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06678737 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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