Recruiting

Observational Study

Sponsor:

University of Utah

Code:

NCT05281445

Conditions

Tourette Syndrome in Children

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Accepted

Interventions

Tic suppression task

Study Details

Brief summary:

Tourette syndrome (TS) is a disabling neurodevelopmental disorder characterized by motor and phonic tics. The studies proposed in this application will explore the endocrine mechanisms underlying two of the least well-understood biological characteristics of TS, namely its marked male predominance and stress susceptibility. In particular, our exploratory studies will characterize the steroid profile in TS-affected boys and girls to identify novel potential biomarkers and therapeutic targets for this disorder.

Conditions

Tourette Syndrome in Children

Study ID

NCT05281445

Start date

May 15, 2023

Status verified date

Oct, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Diagnostic criteria of TS for cases (and lack of any tic disorders for controls)
  • Age between 8 and 12 years old (this age range is to ensure that TS participants can perform the tic suppression task)
  • confirmation of sexual development by parent and/or self-reported Tanner stage of pubic hair development.

Exclusion Criteria:

  • major psychiatric disorders such as a psychotic disorder, autism spectrum disorder, conduct disorder, and substance use disorder;
  • other neurological disorders;
  • clinically significant endocrinological disorders;
  • use of therapies that can modify hormonal profile;
  • pharmacotherapies that may change stress sensitivity, such as antidepressants and anxiolytics.

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Tic suppression

Children with tics will undergo a tic suppression experimental paradigm.

Interventions

Tic suppression task

Tic Suppression Task (TST, administered to Tourette syndrome participants only): At the beginning of the task, the child participant will be seated alone in front of a computer monitor with a countdown timer visible on the screen. For the first 10 minutes (baseline condition) they will be asked to tic freely and not to try to suppress their tics. For the second 10 minutes children will be asked to suppress their tics and will receive points for successful suppression. Participants will then be asked to sit alone in the room and tic freely for an additional 10-minutes.

Primary outcome measure

  • Salivary allopregnanolone concentrations [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Marco Bortolato, MD PhD

8015873352marco.bortolato@utah.edu

Michael Himle, PhD

8015817529michael.himle@utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Michael Himle, PhD

8015817529michael.himle@utah.edu

More Information

Sponsor

University of Utah

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by University of Utah on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.