NCT03851484

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Apr 2019Dec 2028

First Submitted

Initial submission to the registry

February 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 17, 2019

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

9 years

First QC Date

February 17, 2019

Last Update Submit

March 10, 2026

Conditions

Tourette Syndrome

Keywords

Tourette syndromepremonitory urgesensory dysregulationhypersensitivity

Outcome Measures

Primary Outcomes (3)

  • 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 1. = agree 2. = disagree 3. = 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 1. = agree 2. = disagree 3. = 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 1. = agree 2. = disagree 3. = 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 Outcomes (6)

  • Change in Sensory Gating Inventory score at 2 years

    2 years

  • Change in Sensory Gating Inventory score at 1 year

    1 year

  • Baseline Sensory Gating Inventory score

    Initial assessment at enrollment (time zero)

  • Change in Premonitory Urge to Tic Scale score at 2 years

    2 years

  • Change in Premonitory Urge to Tic Scale score at 1 year

    1 year

  • +1 more secondary outcomes

Other Outcomes (24)

  • Yale Global Tic Severity Scale Total Tic Score at baseline

    Initial assessment at enrollment (time zero)

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

    1 year

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

    2 years

  • +21 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • History of psychotic disorder
  • History of significant neurologic disorder (e.g., stroke) other than TS or another chronic tic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-5400, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Related 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.comppsych.2021.152291. Epub 2021 Dec 17.

    PMID: 34952304RESULT

  • 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: 33776814RESULT

  • 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: 33173296RESULT

MeSH Terms

Conditions

Tourette SyndromeHypersensitivity

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersImmune System Diseases

Study Officials

  • David A Isaacs, MD, MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Eckland, BS

CONTACT

615-875-7394michelle.r.eckland.1@vumc.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

February 17, 2019

First Posted

February 22, 2019

Study Start

April 17, 2019

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

US(2)