Longitudinal Impact of Stressors in Adults With Tourette Syndrome (LISA-TS)
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|ClinicalTrials.gov Identifier: NCT04851678|
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : November 8, 2022
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|Condition or disease||Intervention/treatment|
|Tourette Syndrome||Other: None - observational study|
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||Longitudinal Impact of Stressors in Adults With Tourette Syndrome|
|Actual Study Start Date :||September 30, 2021|
|Estimated Primary Completion Date :||March 1, 2024|
|Estimated Study Completion Date :||June 30, 2024|
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
None - observational study
- Total Tic Score from Yale Global Tic Severity Scale (YGTSS) [ Time Frame: 2 years post-baseline assessment ]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 [ Time Frame: 2 years post-baseline assessment ]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 [ Time Frame: 2 years post-baseline assessment ]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.
- NeuroQOL-Anxiety Score [ Time Frame: 2 years post-baseline assessment ]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 [ Time Frame: 2 years post-baseline assessment ]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 [ Time Frame: 2 years post-baseline assessment ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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
- significant medical, neurologic, or psychiatric diagnoses (e.g. uncontrolled epilepsy, chronic heart failure, schizophrenia) besides TS and its commonly co-occurring psychiatric diagnoses
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851678
|Contact: Michelle Eckland, BSfirstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232-5400|
|Contact: Michelle Eckland, BS 615-936-2025 email@example.com|
|Principal Investigator: David Isaacs, MD, MPH|
|Principal Investigator:||David A Isaacs, MD, MPH||Vanderbilt University Medical Center|
|Responsible Party:||David Isaacs, Assistant Professor, Neuro-Movement Disorders Division, Vanderbilt University Medical Center|
|Other Study ID Numbers:||
|First Posted:||April 20, 2021 Key Record Dates|
|Last Update Posted:||November 8, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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