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Trial record 2 of 13 for:    Tourette Syndrome | Nashville, Tennessee, U.S.

Longitudinal Impact of Stressors in Adults With Tourette Syndrome (LISA-TS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04851678
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : November 1, 2021
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
David Isaacs, Vanderbilt University Medical Center

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).

Condition or disease Intervention/treatment
Tourette Syndrome Other: None - observational study

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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
Study Population
adults (>18 years of age) with Tourette syndrome or other chronic tic disorder
Criteria

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


Information from the National Library of Medicine

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


Contacts
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Contact: Michelle Eckland, BS 615-875-7394 michelle.r.eckland.1@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-5400
Contact: Michelle Eckland, BS    615-936-2025    michelle.r.eckland.1@vumc.org   
Principal Investigator: David Isaacs, MD, MPH         
Sponsors and Collaborators
Vanderbilt University Medical Center
University of California, Los Angeles
Investigators
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Principal Investigator: David A Isaacs, MD, MPH Vanderbilt University Medical Center
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Responsible Party: David Isaacs, Assistant Professor, Neuro-Movement Disorders Division, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04851678    
Other Study ID Numbers: U12134
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Isaacs, Vanderbilt University Medical Center:
Stress
Environmental stress
Psychosocial stress
Additional relevant MeSH terms:
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Tourette Syndrome
Syndrome
Disease
Pathologic Processes
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
Neurodevelopmental Disorders
Mental Disorders