Clinical trial NCT03851484: Sensory Symptoms in Tourette Syndrome
Official title: Sensory Symptoms in Tourette Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tourette Syndrome
Keywords: Tourette syndrome
premonitory urge
sensory dysregulation
hypersensitivity
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals 18 years and older with Tourette syndrome or other chronic tic disorder

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.

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

Primary outcomes:
measure: Baseline Sensory Perception Quotient score, short form
timeFrame: Initial assessment at enrollment (time zero)
measure: Change in Sensory Perception Quotient score, short form at 1 year
timeFrame: 1 year
measure: Change in Sensory Perception Quotient score, short form at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Change in Sensory Gating Inventory score at 2 years
timeFrame: 2 years
measure: Change in Sensory Gating Inventory score at 1 year
timeFrame: 1 year
measure: Baseline Sensory Gating Inventory score
timeFrame: Initial assessment at enrollment (time zero)
measure: Change in Premonitory Urge to Tic Scale score at 2 years
timeFrame: 2 years
measure: Change in Premonitory Urge to Tic Scale score at 1 year
timeFrame: 1 year
measure: Baseline Premonitory Urge to Tic Scale score
timeFrame: Initial assessment at enrollment (time zero)
Other outcomes:
measure: Yale Global Tic Severity Scale Total Tic Score at baseline
timeFrame: Initial assessment at enrollment (time zero)
measure: Change in Yale Global Tic Severity Scale Total Tic Score at 1 year
timeFrame: 1 year
measure: Change in Yale Global Tic Severity Scale Total Tic Score at 2 years
timeFrame: 2 years
measure: Dimensional Obsessive Compulsive Scale (DOCS) at baseline
timeFrame: Initial assessment at enrollment (time zero)
measure: Dimensional Obsessive Compulsive Scale (DOCS) at 1 year
timeFrame: 1 year
measure: Dimensional Obsessive Compulsive Scale (DOCS) at 2 years
timeFrame: 2 years
measure: Adult ADHD Self-Report Screening Scale for DSM-5 at baseline
timeFrame: Initial assessment at enrollment (time zero)
measure: Adult ADHD Self-Report Screening Scale for DSM-5 at 1 year
timeFrame: 1 year
measure: Adult ADHD Self-Report Screening Scale for DSM-5 at 2 years
timeFrame: 2 years
measure: Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) at baseline
timeFrame: Initial assessment at enrollment (time zero)
measure: Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) at 1 year
timeFrame: 1 year
measure: Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) at 2 years
timeFrame: 2 years
measure: Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) at baseline
timeFrame: Initial assessment at enrollment (time zero)
measure: Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) at 1 year
timeFrame: 1 year
measure: Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) at 2 years
timeFrame: 2 years
measure: Body Perception Questionnaire - Short Form (BPQ-SF) at baseline
timeFrame: Initial assessment at enrollment (time zero)
measure: Body Perception Questionnaire - Short Form (BPQ-SF) at 1 year
timeFrame: 1 year
measure: Body Perception Questionnaire - Short Form (BPQ-SF) at 2 years
timeFrame: 2 year
measure: Generalized Anxiety Disorder 7 (GAD-7) at baseline
timeFrame: Initial assessment at enrollment (time zero)
measure: Generalized Anxiety Disorder 7 (GAD-7) at 1 year
timeFrame: 1 year
measure: Generalized Anxiety Disorder 7 (GAD-7) at 2 years
timeFrame: 2 years
measure: Patient Health Questionnaire 9 (PHQ-9) at baseline
timeFrame: Initial assessment at enrollment (time zero)
measure: Patient Health Questionnaire 9 (PHQ-9) at 1 year
timeFrame: 1 year
measure: Patient Health Questionnaire 9 (PHQ-9) at 2 years
timeFrame: 2 years
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David A Isaacs, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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/NDT.S274165. eCollection 2020.