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Recruiting NCT03851484

Sensory Symptoms in Tourette Syndrome

Observational Tourette Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Tourette Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Baseline Sensory Perception Quotient score, short form [Time frame: Initial assessment at enrollment (time zero)]
  • Change in Sensory Perception Quotient score, short form at 1 year [Time frame: 1 year]
  • Change in Sensory Perception Quotient score, short form at 2 years [Time frame: 2 years]
Secondary outcome measures (6)
  • Change in Sensory Gating Inventory score at 2 years [Time frame: 2 years]
  • Change in Sensory Gating Inventory score at 1 year [Time frame: 1 year]
  • Baseline Sensory Gating Inventory score [Time frame: Initial assessment at enrollment (time zero)]
  • Change in Premonitory Urge to Tic Scale score at 2 years [Time frame: 2 years]
  • Change in Premonitory Urge to Tic Scale score at 1 year [Time frame: 1 year]
  • Baseline Premonitory Urge to Tic Scale score [Time frame: Initial assessment at enrollment (time zero)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Vanderbilt University Medical Center — Nashville
  • Vanderbilt University Medical Center — Nashville

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. PMID 34952304
  • 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. PMID 33776814
  • 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. PMID 33173296

Identifiers

NCT: NCT03851484 · VUMCSenST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗