Sensory Symptoms in Tourette Syndrome

• Conditions: Tourette Syndrome

• Registration Number: NCT03851484
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-17
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-22
• Study Start: 2019-04-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17
• Primary Completion: 2028-03-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline Sensory Perception Quotient score, short form	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 2 years	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.
Change in Sensory Perception Quotient score, short form at 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Baseline Premonitory Urge to Tic Scale score	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.
Change in Premonitory Urge to Tic Scale score at 2 years	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 Sensory Gating Inventory score at 1 year	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	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 Sensory Gating Inventory score at 2 years	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 Premonitory Urge to Tic Scale score at 1 year	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States