Longitudinal Impact of Stressors in Adults With Tourette Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • None - observational study

    Other intervention

    None - observational study

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: Individuals with Tourette syndrome (TS)1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years post-baseline assessment
2

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.

Time frame
2 years post-baseline assessment
3

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.

Time frame
2 years post-baseline assessment

Secondary outcomes

1

NeuroQOL-Anxiety Score

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

Time frame
2 years post-baseline assessment
2

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

ASRS-V is a 6-question scale screening for symptoms of inattention and hyperactivity. Each item is rated 0 ("never") to 4 ("very often"). Total score is the sum of individual item scores. Higher score indicates more ADHD symptoms. In clinical populations, ASRS-V total score cutoff ≥ 14 is 81% sensitive and 70% specific for detecting ADHD.

Time frame
2 years post-baseline assessment
3

Dimensional Obsessive-Compulsive Scale (DOCS) Score

DOCS is a 20-item, validated self-report scale assessing for severity of obsessive-compulsive symptoms. Total score ranges from 0-80, with higher scores indicating more OCD symptoms. In clinical populations, DOCS total score cutoff ≥ 21 is 70% sensitive and 70% specific in distinguishing OCD from other anxiety disorders.

Time frame
2 years post-baseline assessment
4

Mini International Neuropsychiatric Interview (MINI)

The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a brief structured diagnostic interview for common DSM-V psychiatric disorders. Scale administration is typically 15-20 minutes. Scale output is presence/absence of psychiatric diagnoses currently and/or in the past.

Time frame
2 years post-baseline assessment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

University of California, Los Angeles

Collaborator