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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
None - observational study
Other interventionNone - observational study
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Vanderbilt University Medical Center
Lead sponsor
University of California, Los Angeles
Collaborator