Recruiting

Observational Study

Sponsor:

Vanderbilt University Medical Center

Code:

NCT04851678

Conditions

Tourette Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

None - observational study

Study Details

Brief summary:

The Investigators propose a two-year, longitudinal pilot study of TS adults (>18) to determine impact of lifetime environmental stress exposure on tic severity, psychiatric comorbidity severity, and health-related quality of life (HRQOL).

Conditions

Tourette Syndrome

Study ID

NCT04851678

Start date

Sep 30, 2021

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • adults (>18) meeting Diagnostic and Statistics Manual, 5th edition (DSM-V) criteria for Tourette syndrome, chronic motor tic disorder, or chronic vocal tic disorder
  • ability to provide informed consent
  • English proficiency

Exclusion Criteria:

\- significant medical, neurologic, or psychiatric diagnoses (e.g. uncontrolled epilepsy, chronic heart failure, schizophrenia) besides TS and its commonly co-occurring psychiatric diagnoses

Study Design

Enrollment

140 participants

Anticipated

Interventions and Outcome Measures

Arms

Individuals with Tourette syndrome (TS)

Individuals previously diagnosed with Tourette syndrome (TS). Participants must be 18 years of age or older.

Interventions

None - observational study

None - observational study

Primary outcome measure

  • Total Tic Score from Yale Global Tic Severity Scale (YGTSS) [ Time Frame: 2 years post-baseline assessment ]
  • NeuroQOL-Depression Score [ Time Frame: 2 years post-baseline assessment ]
  • Gilles de la Tourette Quality of Life Scale (GTS-QOL) Score [ Time Frame: 2 years post-baseline assessment ]

Central Contacts and Locations

Central contacts

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232-5400

Contacts

Principal Investigator:

David Isaacs, MD, MPH

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • Stress
  • Environmental stress
  • Psychosocial stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-05.