Sensory Symptoms in Tourette Syndrome (SenST)

• ClinicalTrials.gov Identifier: NCT03851484
• Recruitment Status: Enrolling by invitation
• First Posted: February 22, 2019
• Last Update Posted: October 5, 2022
• Sponsor: Vanderbilt University Medical Center
• 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: October 5, 2022
• Actual Study Start Date: April 17, 2019
• Estimated Primary Completion Date: March 2028 (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

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 ADHD Self-Report Screening Scale, and others. These questionnaires will be administered annually to patients. For the analysis, participants will be stratified by age into late adolescents (18-25 years old) and adults (older than 25 years) since adolescent development ends at approximately age 25.
• 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: Individuals 18 years and older with Tourette syndrome or other chronic tic disorder
• Condition: Tourette Syndrome
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: October 4, 2022): 214
• Original Estimated Enrollment (submitted: February 20, 2019): 100
• Estimated Study Completion Date: December 2028
• Estimated Primary Completion Date: March 2028 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

• 18 years of age or older
• Ability to provide informed consent and answer self-report questionnaires independently in English
• Diagnosis of Tourette syndrome (TS), chronic motor tic disorder, or chronic vocal tic disorder

Exclusion criteria:

• History of psychotic disorder
• History of significant neurologic disorder (e.g., stroke) other than TS or another chronic tic disorder

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

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

• Current Responsible Party: David Isaacs, Vanderbilt University Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Vanderbilt University Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: David A Isaacs, MD, MPH; Vanderbilt University Medical Center

• PRS Account: Vanderbilt University Medical Center
• Verification Date: October 2022