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Sensory Symptoms in Tourette Syndrome (SenST)

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ClinicalTrials.gov Identifier: NCT03851484
Recruitment Status : Enrolling by invitation
First Posted : February 22, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
David Isaacs, Vanderbilt University Medical Center

Tracking Information
First Submitted Date February 17, 2019
First Posted Date February 22, 2019
Last Update Posted Date April 23, 2019
Actual Study Start Date April 17, 2019
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 20, 2019)
  • Baseline Sensory Perception Quotient score, short form [ Time Frame: Initial assessment at enrollment (time zero) ]
    Validated instrument assessing anomalous sensory experiences. Scale consists of 35 items screening patients for hyper- or hypo-sensitivity to each of the sensory domains (touch, sight, sound, smell, and taste). Each scale item is a statement to which participants provide a ranking: 0 = strongly agree
    1. = agree
    2. = disagree
    3. = strongly disagree The minimum score on the short from is 0; the maximum score is 140. Higher scores indicate more abnormal sensory experiences.
  • Change in Sensory Perception Quotient score, short form at 1 year [ Time Frame: 1 year ]
    Validated instrument assessing anomalous sensory experiences. Scale consists of 35 items screening patients for hyper- or hypo-sensitivity to each of the sensory domains (touch, sight, sound, smell, and taste). Each scale item is a statement to which participants provide a ranking: 0 = strongly agree
    1. = agree
    2. = disagree
    3. = strongly disagree The minimum score on the short from is 0; the maximum score is 140. Higher scores indicate more abnormal sensory experiences.
  • Change in Sensory Perception Quotient score, short form at 2 years [ Time Frame: 2 years ]
    Validated instrument assessing anomalous sensory experiences. Scale consists of 35 items screening patients for hyper- or hypo-sensitivity to each of the sensory domains (touch, sight, sound, smell, and taste). Each scale item is a statement to which participants provide a ranking: 0 = strongly agree
    1. = agree
    2. = disagree
    3. = strongly disagree The minimum score on the short from is 0; the maximum score is 140. Higher scores indicate more abnormal sensory experiences.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03851484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 20, 2019)
  • Change in Sensory Gating Inventory score at 2 years [ Time Frame: 2 years ]
    Validated instrument assessing anomalous sensory experiences. The scale consists of 36 items screening patients for hyper- or hypo-sensitivity to several of the sensory domains (primarily sight and sound). Each scale item is a statement to which participants provide a ranking:
    1. = never true
    2. = infrequently true
    3. = sometimes but infrequently true
    4. = sometimes true
    5. = true
    6. = always true The minimum score on the scale is 36; the maximum score is 216. Higher scores indicate more abnormal sensory experiences.
  • Change in Sensory Gating Inventory score at 1 year [ Time Frame: 1 year ]
    Validated instrument assessing anomalous sensory experiences. The scale consists of 36 items screening patients for hyper- or hypo-sensitivity to several of the sensory domains (primarily sight and sound). Each scale item is a statement to which participants provide a ranking:
    1. = never true
    2. = infrequently true
    3. = sometimes but infrequently true
    4. = sometimes true
    5. = true
    6. = always true The minimum score on the scale is 36; the maximum score is 216. Higher scores indicate more abnormal sensory experiences.
  • Baseline Sensory Gating Inventory score [ Time Frame: Initial assessment at enrollment (time zero) ]
    Validated instrument assessing anomalous sensory experiences. The scale consists of 36 items screening patients for hyper- or hypo-sensitivity to several of the sensory domains (primarily sight and sound). Each scale item is a statement to which participants provide a ranking:
    1. = never true
    2. = infrequently true
    3. = sometimes but infrequently true
    4. = sometimes true
    5. = true
    6. = always true The minimum score on the scale is 36; the maximum score is 216. Higher scores indicate more abnormal sensory experiences.
  • Change in Premonitory Urge to Tic Scale score at 2 years [ Time Frame: 2 years ]
    Validated instrument assessing type and extent of premonitory sensations. The scale consists of 9 scored items and 1 non-scored item, all assessing degree of abnormal sensations and urges preceding a tic. The scored scale items are ranked 1-4, with 4 being the most abnormal. The minimum score on the scale is 9; the maximum score is 36. Higher scores indicate more frequent and severe premonitory urges.
  • Change in Premonitory Urge to Tic Scale score at 1 year [ Time Frame: Change from baseline score at 1 year ]
    Validated instrument assessing type and extent of premonitory sensations. The scale consists of 9 scored items and 1 non-scored item, all assessing degree of abnormal sensations and urges preceding a tic. The scored scale items are ranked 1-4, with 4 being the most abnormal. The minimum score on the scale is 9; the maximum score is 36. Higher scores indicate more frequent and severe premonitory urges.
  • Baseline Premonitory Urge to Tic Scale score [ Time Frame: Initial assessment at enrollment (time zero) ]
    Validated instrument assessing type and extent of premonitory sensations. The scale consists of 9 scored items and 1 non-scored item, all assessing degree of abnormal sensations and urges preceding a tic. The scored scale items are ranked 1-4, with 4 being the most abnormal. The minimum score on the scale is 9; the maximum score is 36. Higher scores indicate more frequent and severe premonitory urges.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sensory Symptoms in Tourette Syndrome
Official Title Sensory Symptoms in Tourette Syndrome
Brief Summary Patients with tics will be asked to complete a series of validated questionnaires (in electronic and/or paper format) regarding symptoms and conditions often associated with Tourette syndrome, including premonitory urges, sensory experiences, inattention, obsessive-compulsive tendencies, anxiety, and depression. Participants will also be asked to complete a quality of life assessment. This series of questionnaires will be administered annually.
Detailed Description Patients with tics will be recruited to participate in an observational study assessing extent and variation in non-motor features of Tourette syndrome over time. Each participant will complete a battery of validated questionnaires and scales online or in paper format (per patient preference), including the Premonitory Urge to Tic Scale (PUTS), the Sensory Gating Inventory (SGI), the Sensory Perception Quotient, the World Health Organization ADHD Self-Report Screening Scale, and others. These questionnaires will be administered annually to patients.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population adults with Tourette syndrome or other tic disorder
Condition Tourette Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: February 20, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • diagnosis of Tourette syndrome or other tic disorder

Exclusion Criteria:

  • age =< 18 years
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03851484
Other Study ID Numbers VUMCSenST
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party David Isaacs, Vanderbilt University Medical Center
Study Sponsor Vanderbilt University Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: David A Isaacs, MD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date April 2019