About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of psychotic disorder
History of significant neurologic disorder (e.g., stroke) other than TS or another chronic tic disorder
Trial population
Individuals 18 years and older with Tourette syndrome or other chronic tic disorder
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Baseline Sensory Perception Quotient score, short form
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
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
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 outcomes
Change in Sensory Gating Inventory score at 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
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
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
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.
Other outcomes
Yale Global Tic Severity Scale Total Tic Score at baseline
Validated, gold-standard clinician-administered tic assessment scale, comprised of 11 items. Scale range: 0 (best) - 100 (worst)
Change in Yale Global Tic Severity Scale Total Tic Score at 1 year
Validated, gold-standard clinician-administered tic assessment scale, comprised of 11 items. Scale range: 0 (best) - 100 (worst)
Change in Yale Global Tic Severity Scale Total Tic Score at 2 years
Validated, gold-standard clinician-administered tic assessment scale, comprised of 11 items. Scale range: 0 (best) - 100 (worst)
Dimensional Obsessive Compulsive Scale (DOCS) at baseline
Validated self-report questionnaire assessing severity of obsessive and compulsive symptoms, comprised of 20 items. Scale range 0 (least affected) - 80 (most affected)
Sponsors and contacts
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