Longitudinal Impact of Stressors in Adults With Tourette Syndrome

NCT04851678 | Recruiting

• 1 other identifier: U12134
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

Stress; Environmental stress; Psychosocial stress

Outcome Measures

Primary Outcomes (3)

• Total Tic Score from Yale Global Tic Severity Scale (YGTSS)

  Semi-structured, clinician-administered interview to assess tic severity. Total tic scores are a composite of motor tic scores (0-25) and phonic tic scores (0-25) based on 5 dimensions of tic severity: number, frequency, intensity, complexity, and interference. Total tic scores range from 0-50. Higher scores indicate great tic severity. The YGTSS is the gold-standard clinical rating scale for tic severity.

  2 years post-baseline assessment

• NeuroQOL-Depression Score

  NeuroQOL-Depression is a validated, 8-item self-report scale assessing symptoms of depression. Raw total scores range from 8-40; raw scores are converted to T-scores based on normative samples. Higher scores indicate more depressive symptoms. NeuroQOL-Depression is part of the Neuro-QOL (Quality of Life in Neurological Disorders) measurement system. The scale is designed to be completed with one minute.

  2 years post-baseline assessment

• Gilles de la Tourette Quality of Life Scale (GTS-QOL) Score

  The GTS-QOL is a 27-item self-report scale. Respondents rate each item on a Likert scale ranging from 0 ("no problem") to 4 ("extreme problem"). The scale is composed of four sub-scales: Psychological (11 items), Physical/Activities of Daily Living (Physical/ADL) (7 items), Obsessive-Compulsive (OC) (5 items), and Cognitive (4 items) (39). Item scores within each subscale are summed and then normalized to 100 to generate the subscale score. The four subscale scores are then summed and normalized to 100 to yield the total score. Higher scores indicate worse health-related quality of life.

  2 years post-baseline assessment

Secondary Outcomes (10)

• NeuroQOL-Anxiety Score

  2 years post-baseline assessment

• Adult ADHD Self-Report Screening Scale for DSM-V (ASRS-V) Score

  2 years post-baseline assessment

• Dimensional Obsessive-Compulsive Scale (DOCS) Score

  2 years post-baseline assessment

• Mini International Neuropsychiatric Interview (MINI)

  2 years post-baseline assessment

• Lifetime Adult STRAIN

  2 years post-baseline assessment

Study Arms (1)

Individuals with Tourette syndrome (TS)

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

Other: None - observational study

Interventions

None - observational study OTHER

None - observational study

Individuals with Tourette syndrome (TS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults (\>18 years of age) with Tourette syndrome or other chronic tic disorder

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: collaborator
• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-5400, United States

RECRUITING

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• David A Isaacs, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Eckland, BS

CONTACT

615-875-7394; michelle.r.eckland.1@vumc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Neuro-Movement Disorders Division

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: September 30, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)