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Clinical Trials/NCT03851484
NCT03851484
Recruiting
N/A

Sensory Symptoms in Tourette Syndrome

Vanderbilt University Medical Center2 sites in 1 country214 target enrollmentApril 17, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tourette Syndrome
Sponsor
Vanderbilt University Medical Center
Enrollment
214
Locations
2
Primary Endpoint
Baseline Sensory Perception Quotient score, short form
Status
Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 17, 2019
End Date
December 31, 2028
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Isaacs

Associate Professor of Neurology

Vanderbilt University Medical Center

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

Outcomes

Primary Outcomes

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 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.

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.

Secondary Outcomes

  • Baseline Premonitory Urge to Tic Scale score(Initial assessment at enrollment (time zero))
  • Change in Premonitory Urge to Tic Scale score at 2 years(2 years)
  • Change in Sensory Gating Inventory score at 1 year(1 year)
  • Baseline Sensory Gating Inventory score(Initial assessment at enrollment (time zero))
  • Change in Sensory Gating Inventory score at 2 years(2 years)
  • Change in Premonitory Urge to Tic Scale score at 1 year(1 year)

Study Sites (2)

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