Sensory Symptoms in Tourette Syndrome (SenST)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 214

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-5400
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals 18 years and older with Tourette syndrome or other chronic tic disorder

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; = 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.	Initial assessment at enrollment (time zero)
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; = 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.	1 year
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; = 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 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: = 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 years
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: = 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.	1 year
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: = 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.	Initial assessment at enrollment (time zero)
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.	2 years
Baseline Premonitory Urge to Tic Scale score	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.	Initial assessment at enrollment (time zero)
Change in Premonitory Urge to Tic Scale 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.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Initial assessment at enrollment (time zero)
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)	1 year
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)	2 years
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)	Initial assessment at enrollment (time zero)
Dimensional Obsessive Compulsive Scale (DOCS) at 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)	1 year
Dimensional Obsessive Compulsive Scale (DOCS) at 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)	2 years
Adult ADHD Self-Report Screening Scale for DSM-5 at baseline	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)	Initial assessment at enrollment (time zero)
Adult ADHD Self-Report Screening Scale for DSM-5 at 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)	1 year
Adult ADHD Self-Report Screening Scale for DSM-5 at 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)	2 years
Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) at baseline	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)	Initial assessment at enrollment (time zero)
Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) at 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)	1 year
Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) at 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)	2 years
Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) at baseline	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.	Initial assessment at enrollment (time zero)
Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) at 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.	1 year
Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) at 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.	2 years
Body Perception Questionnaire - Short Form (BPQ-SF) at baseline	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.	Initial assessment at enrollment (time zero)
Body Perception Questionnaire - Short Form (BPQ-SF) at 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.	1 year
Body Perception Questionnaire - Short Form (BPQ-SF) at 2 years	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.	2 year

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: David A Isaacs, MD, MPH, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• Isaacs D, Key AP, Cascio CJ, Conley AC, Riordan H, Walker HC, Wallace MT, Claassen DO. Cross-disorder comparison of sensory over-responsivity in chronic tic disorders and obsessive-compulsive disorder. Compr Psychiatry. 2022 Feb;113:152291. doi: 10.1016/j.comppsych.2021.152291. Epub 2021 Dec 17.
• Isaacs DA, Riordan HR, Claassen DO. Clinical Correlates of Health-Related Quality of Life in Adults With Chronic Tic Disorder. Front Psychiatry. 2021 Mar 10;12:619854. doi: 10.3389/fpsyt.2021.619854. eCollection 2021.
• Isaacs D, Key AP, Cascio CJ, Conley AC, Walker HC, Wallace MT, Claassen DO. Sensory Hypersensitivity Severity and Association with Obsessive-Compulsive Symptoms in Adults with Tic Disorder. Neuropsychiatr Dis Treat. 2020 Nov 2;16:2591-2601. doi: 10.2147/NDT.S274165. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 17, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: hypersensitivity; Tourette syndrome; sensory dysregulation; premonitory urge
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Tourette Syndrome
• Other Study ID Numbers: VUMCSenST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No