Sensory Symptoms in Tourette Syndrome

Tourette Syndrome Clinical Trial

— SenST  

Official title:

Sensory Symptoms in Tourette Syndrome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03851484
• Other study ID #: VUMCSenST
• Status: Enrolling by invitation
• Start date: April 17, 2019
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 214
• Est. completion date: December 31, 2028
• Est. primary completion date: March 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View Citation

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/N — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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
Other	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
Other	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)
Other	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
Other	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
Other	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)
Other	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
Other	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
Other	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)
Other	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
Other	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
Other	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)
Other	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
Other	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
Other	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)
Other	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
Other	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
Primary	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)
Primary	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
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)