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Sensory Symptoms in Tourette Syndrome (SenST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03851484
Recruitment Status : Enrolling by invitation
First Posted : February 22, 2019
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
David Isaacs, Vanderbilt University Medical Center

Study Description
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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.

Condition or disease
Tourette Syndrome

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 Design
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Study Type : Observational
Estimated Enrollment : 214 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sensory Symptoms in Tourette Syndrome
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : March 2028
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals 18 years and older with Tourette syndrome or other chronic tic disorder
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851484


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-5400
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: David A Isaacs, MD, MPH Vanderbilt University Medical Center
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: David Isaacs, Assistant Professor of Neurology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03851484    
Other Study ID Numbers: VUMCSenST
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Isaacs, Vanderbilt University Medical Center:
Tourette syndrome
premonitory urge
sensory dysregulation
hypersensitivity
Additional relevant MeSH terms:
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Tourette Syndrome
Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders