NCT04335175

Brief Summary

This study seeks to address two key questions related to sensory dysregulation in Tourette syndrome (TS) and obsessive compulsive disorder (OCD): 1) Is sensory dysregulation in OCD clinically distinct from that in TS? 2) To what extent does sensory dysregulation affect QOL in each of these disorders? Patients with TS, patients with OCD, and healthy controls will complete an online battery of validated questionnaires assessing sensory dysregulation, psychiatric symptoms, and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

April 14, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

April 2, 2020

Last Update Submit

March 14, 2022

Conditions

Keywords

sensory dysregulationsensory gating dysfunctionticobsessive compulsivesensory symptom

Outcome Measures

Primary Outcomes (1)

  • Sensory Gating Inventory

    36-item, validated self-report questionnaire assessing sensory gating symptoms, with score range 0-216. Higher scores indicate greater sensory gating impairment.

    Day 1

Secondary Outcomes (7)

  • Dimensional Obsessive Compulsive Scale

    Day 1

  • Adult Attention Deficit Hyperactivity Disorder Self-Report Screening Scale

    Day 1

  • Generalized Anxiety Disorder-7 Scale

    Day 1

  • Patient Health Questionnaire-9 Scale

    Day 1

  • Premonitory Urge to Tic Scale (for Tourette syndrome patients only)

    Day 1

  • +2 more secondary outcomes

Study Arms (3)

Tourette Syndrome

Individuals previously diagnosed with Tourette syndrome (TS). Participants must be 18 years of age or older.

Other: None - observational study

Obsessive Compulsive Disorder

Individuals previously diagnosed with obsessive compulsive disorder (OCD). Participants must be 18 years of age or older.

Other: None - observational study

Healthy Controls

Individuals with no past or current neurologic or psychiatric illness. Participants must be 18 years of age or older.

Other: None - observational study

Interventions

None - observational study

Healthy ControlsObsessive Compulsive DisorderTourette Syndrome

Eligibility Criteria

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

Individuals 18 years of age or older with Tourette syndrome and/or obsessive compulsive disorder. Individuals 18 years of age or older with no neurologic or psychiatric diagnoses.

You may qualify if:

  • age 18 years or older
  • previous diagnosis of Tourette syndrome and/or obsessive compulsive disorder

You may not qualify if:

  • \- none
  • \- 18 years of age or older
  • \- history of any neurologic or psychiatric diagnoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-5400, United States

Location

MeSH Terms

Conditions

Tourette SyndromeObsessive-Compulsive DisorderSensation DisordersTics

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 DisordersAnxiety DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesias

Study Officials

  • David Isaacs, MD, MPH

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 6, 2020

Study Start

April 14, 2020

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

All deidentified participant data collected, study protocol, statistical analysis plan, and informed consent documents will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 3 months and ending 5 years following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be directed to david.a.isaacs@vumc.org. To gain access, data requestors will need to sign a data access agreement.

Locations