Exploring the Role of Neuroactive Steroids in Tourette Syndrome

NCT05281445 | Unknown

• 1 other identifier: 00150143
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Salivary allopregnanolone concentrations

  Change of concentrations of salivary allopregnanolone, as measured by chromatography/ mass spectrometry. All concentrations will be expressed in pg/ml.

  Through study completion, an average of 2 years

Secondary Outcomes (1)

• Tic frequency

  Through study completion, an average of 2 years

Other Outcomes (1)

• Measurement of salivary concentrations of other neuroactive steroids

  Through study completion, an average of 2 years

Study Arms (1)

Tic suppression

EXPERIMENTAL

Children with tics will undergo a tic suppression experimental paradigm.

Behavioral: Tic suppression task

Interventions

Tic suppression task BEHAVIORAL

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.

Tic suppression

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• University of Miami: collaborator
• Albert Einstein College of Medicine: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Study Officials

• Marco Bortolato, MD PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Bortolato, MD PhD

CONTACT

8015873352; marco.bortolato@utah.edu

Michael Himle, PhD

CONTACT

8015817529; michael.himle@utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Tic suppression task

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 16, 2022
• Study Start: April 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)