ClinicalTrials.gg
RecruitingNCT06679790Updated Jul 17, 2026

Trajectories of Change in Tourette Syndrome

An interventional study of Comprehensive Behavioral Intervention for Tics in Tourette Syndrome and Tic Disorders, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
12 Years to 17 Years
Sex
All
01

Study summary

This K23 Career Development Award is designed to provide the training needed for the PI to achieve her long-term career goal of conducting independent, programmatic intervention research in developmental populations. The training will emphasize gaining expertise in higher-intensity, multi-method, within-subject data collection and analysis. This award builds on the PI's emerging experience in tic disorders and pediatric behavioral interventions, and her ability to quickly learn and apply advanced statistical methods. The award will extend the PI's training through the following short-term training goals: 1) multi-method data collection and integration (electronic momentary assessment [EMA], wearable devices, neurocognitive tasks), 2) leading and designing pediatric clinical trials, 3) managing and analyzing large, multilevel datasets, and 4) career development and contribution to the field. The PI has developed a training plan to accomplish these goals in concert with her mentors, a team of leading experts in the fields of psychiatry and psychology, who will closely monitor training through regular meetings. The highly structured training plan also includes a set of formal coursework and workshops for each training goal to complement the hands-on experience the PI will gain from leading the research project.

The objective of this proposal is to comprehensively map symptom change across time and during a behavioral intervention for youth with Persistent Tic Disorders (PTDs). PTDs affect approximately 1% of the population, can cause significant disability, have high rates of comorbidity, and are associated with a four-fold increase in suicide risk. Research has established that tic symptoms and their change over time are highly idiographic. However, first-line, evidence-based, existing interventions are "one-size-fits-all," and are only effective for 60% of patients. The current study aims to use advanced statistical methods and a novel theoretical framework to map the stability of tic patterns, along with systemic factors that relate to tic change over time. Study hypotheses, based on the literature and preliminary data, are that a) tic change patterns will be stable before intervention for all participants, b) disruption of stable patterns during the intervention phase will be associated with treatment response, and c) this disruption will depend on the specific driver of tic symptoms pre-intervention. N = 30 youth ages 12-17 with chronic tics will be recruited for the study. There will be three study phases: 1) pre-intervention (4 weeks), 2) intervention (8 weeks), and 3) post-intervention (4 weeks). Before and between each phase, participants will complete 4 traditional assessments to assess symptoms and treatment response. Throughout the 16 weeks of the study, we will collect EMA data focused on factors relevant to tics (4x per day), physiological data from wearable devices (passive, continuous), and neurocognitive task performance and tic video observation (1x per week). Results will inform efforts to develop individualized interventions for individuals with PTDs to improve treatment outcomes.

02

Conditions studied

  • Tourette Syndrome
  • Tic Disorders
03

In context

Tourette Syndrome

240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.

This study's planned enrollment of 30 is below the median of 36 across 183 interventional studies indexed under Tourette Syndrome.

Browse Tourette Syndrome studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Presence of 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.
  2. At least moderate tic severity, defined as a Yale Global Tic Severity Scale44 total score ≥14 (≥9 for those with motor or vocal tics only).
  3. Participants must be fluent in English to ensure comprehension of study measures and instructions.

Exclusion criteria

Exclusion Criteria:

  1. Previous diagnosis of psychosis or cognitive disability,
  2. IQ \< 80,
  3. Substance abuse or dependence within the past year.
  4. Current suicidal intent.
  5. Changes in medication in the previous 4 weeks.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Comprehensive Behavioral Intervention for Tics (CBIT)

    behavior therapy for tics

    Behavioral: Comprehensive Behavioral Intervention for Tics

Interventions

  • BehavioralComprehensive Behavioral Intervention for Tics

    All participants will receive 8 sessions of CBIT following a published treatment manual.

06

What researchers measure

Primary outcomes

  1. Clinical scales of tic change

    ecological momentary assessment outcomes of tic change

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for May 2029, 49 months after the start.

Of 65 non-industry interventional studies with no phase under Tourette Syndrome, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's planned 49 months is above that.

Counting every sponsor, half of 65 studies reached it within 33 months; a quarter within 22 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2024
First posted
Nov 8, 2024
StartActual
Mar 31, 2025
Primary completionEst.
May 15, 2029
CompletionEst.
May 15, 2029
Last update
Jul 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06679790
Responsible party
Sponsor
First posted
Nov 8, 2024
Start date
Mar 31, 2025
Primary completion
May 15, 2029 (estimated)
Completion
May 15, 2029 (estimated)
Last update
Jul 17, 2026

Study contacts

IaOom Khang
Contact
612-624-7830
Brianna Wellen
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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