Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03851484

Sensory Symptoms in Tourette Syndrome

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Hypersensitivity Immune System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

    • = agree
    • = disagree
    • = 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

    • = agree
    • = disagree
    • = 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

    • = agree
    • = disagree
    • = 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

  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:

    • = never true
    • = infrequently true
    • = sometimes but infrequently true
    • = sometimes true
    • = true
    • = 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:

    • = never true
    • = infrequently true
    • = sometimes but infrequently true
    • = sometimes true
    • = true
    • = 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:

    • = never true
    • = infrequently true
    • = sometimes but infrequently true
    • = sometimes true
    • = true
    • = 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: 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.

Other outcomes

  1. Yale Global Tic Severity Scale Total Tic Score at baseline

    Time frame: Initial assessment at enrollment (time zero)

    Validated, gold-standard clinician-administered tic assessment scale, comprised of 11 items. Scale range: 0 (best) - 100 (worst)

  2. Change in Yale Global Tic Severity Scale Total Tic Score at 1 year

    Time frame: 1 year

    Validated, gold-standard clinician-administered tic assessment scale, comprised of 11 items. Scale range: 0 (best) - 100 (worst)

  3. Change in Yale Global Tic Severity Scale Total Tic Score at 2 years

    Time frame: 2 years

    Validated, gold-standard clinician-administered tic assessment scale, comprised of 11 items. Scale range: 0 (best) - 100 (worst)

  4. Dimensional Obsessive Compulsive Scale (DOCS) at baseline

    Time frame: Initial assessment at enrollment (time zero)

    Validated self-report questionnaire assessing severity of obsessive and compulsive symptoms, comprised of 20 items. Scale range 0 (least affected) - 80 (most affected)

  5. Dimensional Obsessive Compulsive Scale (DOCS) at 1 year

    Time frame: 1 year

    Validated self-report questionnaire assessing severity of obsessive and compulsive symptoms, comprised of 20 items. Scale range 0 (least affected) - 80 (most affected)

  6. Dimensional Obsessive Compulsive Scale (DOCS) at 2 years

    Time frame: 2 years

    Validated self-report questionnaire assessing severity of obsessive and compulsive symptoms, comprised of 20 items. Scale range 0 (least affected) - 80 (most affected)

  7. Adult ADHD Self-Report Screening Scale for DSM-5 at baseline

    Time frame: Initial assessment at enrollment (time zero)

    Validated self-report scale, developed since release of Diagnostic and Statistical Manual-V, comprised of 6 items. Scale range 0 (least affected) - 24 (most affected)

  8. Adult ADHD Self-Report Screening Scale for DSM-5 at 1 year

    Time frame: 1 year

    Validated self-report scale, developed since release of Diagnostic and Statistical Manual-V, comprised of 6 items. Scale range 0 (least affected) - 24 (most affected)

  9. Adult ADHD Self-Report Screening Scale for DSM-5 at 2 years

    Time frame: 2 years

    Validated self-report scale, developed since release of Diagnostic and Statistical Manual-V, comprised of 6 items. Scale range 0 (least affected) - 24 (most affected)

  10. Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) at baseline

    Time frame: Initial assessment at enrollment (time zero)

    Validated self-report questionnaire assessing health-related quality of life for patients with Tourette syndrome, comprised of 27 items. Scale range 0 (best quality of life) - 108 (worst quality of life)

  11. Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) at 1 year

    Time frame: 1 year

    Validated self-report questionnaire assessing health-related quality of life for patients with Tourette syndrome, comprised of 27 items. Scale range 0 (best quality of life) - 108 (worst quality of life)

  12. Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) at 2 years

    Time frame: 2 years

    Validated self-report questionnaire assessing health-related quality of life for patients with Tourette syndrome, comprised of 27 items. Scale range 0 (best quality of life) - 108 (worst quality of life)

  13. Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) at baseline

    Time frame: Initial assessment at enrollment (time zero)

    Validated self-report questionnaire assessing interoceptive sensibility, comprised of 37 items. Each scale item is a statement to which respondents must select "never" (0) to "always" (5) on a six-point Likert scale. No total MAIA-2 score exists. Rather, individual scale items belong to one of eight MAIA-2 subscales. For each subscale, higher score signifies more of that construct.

  14. Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) at 1 year

    Time frame: 1 year

    Validated self-report questionnaire assessing interoceptive sensibility, comprised of 37 items. Each scale item is a statement to which respondents must select "never" (0) to "always" (5) on a six-point Likert scale. No total MAIA-2 score exists. Rather, individual scale items belong to one of eight MAIA-2 subscales. For each subscale, higher score signifies more of that construct.

  15. Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) at 2 years

    Time frame: 2 years

    Validated self-report questionnaire assessing interoceptive sensibility, comprised of 37 items. Each scale item is a statement to which respondents must select "never" (0) to "always" (5) on a six-point Likert scale. No total MAIA-2 score exists. Rather, individual scale items belong to one of eight MAIA-2 subscales. For each subscale, higher score signifies more of that construct.

  16. Body Perception Questionnaire - Short Form (BPQ-SF) at baseline

    Time frame: Initial assessment at enrollment (time zero)

    Validated self-report questionnaire assessing interoceptive sensibility, comprised of 46 items total, divided into 3 sections: Body Awareness (raw total score 26-130), Supradiaphragmatic Reactivity (raw total score 15-69), and Subdiaphragmatic Reactivity (raw total score 6-28). Raw scores are converted to T-scores. Higher raw and T-scores indicate greater maladaptive body awareness.

  17. Body Perception Questionnaire - Short Form (BPQ-SF) at 1 year

    Time frame: 1 year

    Validated self-report questionnaire assessing interoceptive sensibility, comprised of 46 items total, divided into 3 sections: Body Awareness (raw total score 26-130), Supradiaphragmatic Reactivity (raw total score 15-69), and Subdiaphragmatic Reactivity (raw total score 6-28). Raw scores are converted to T-scores. Higher raw and T-scores indicate greater maladaptive body awareness.

  18. Body Perception Questionnaire - Short Form (BPQ-SF) at 2 years

    Time frame: 2 year

    Validated self-report questionnaire assessing interoceptive sensibility, comprised of 46 items total, divided into 3 sections: Body Awareness (raw total score 26-130), Supradiaphragmatic Reactivity (raw total score 15-69), and Subdiaphragmatic Reactivity (raw total score 6-28). Raw scores are converted to T-scores. Higher raw and T-scores indicate greater maladaptive body awareness.

  19. Generalized Anxiety Disorder 7 (GAD-7) at baseline

    Time frame: Initial assessment at enrollment (time zero)

    Validated self-report scale for anxiety, comprised of 7 items. Scale range 0 (least severe) - 21 (most severe).

  20. Generalized Anxiety Disorder 7 (GAD-7) at 1 year

    Time frame: 1 year

    Validated self-report scale for anxiety, comprised of 7 items. Scale range 0 (least severe) - 21 (most severe).

  21. Generalized Anxiety Disorder 7 (GAD-7) at 2 years

    Time frame: 2 years

    Validated self-report scale for anxiety, comprised of 7 items. Scale range 0 (least severe) - 21 (most severe).

  22. Patient Health Questionnaire 9 (PHQ-9) at baseline

    Time frame: Initial assessment at enrollment (time zero)

    Validated self-report scale for depression, comprised of 9 items. Scale range 0 (least severe) - 27 (most severe).

  23. Patient Health Questionnaire 9 (PHQ-9) at 1 year

    Time frame: 1 year

    Validated self-report scale for depression, comprised of 9 items. Scale range 0 (least severe) - 27 (most severe).

  24. Patient Health Questionnaire 9 (PHQ-9) at 2 years

    Time frame: 2 years

    Validated self-report scale for depression, comprised of 9 items. Scale range 0 (least severe) - 27 (most severe).

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Eckland, BS

CONTACT

[email protected]

615-875-7394

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: SenST

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Feb 22, 2019
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.