Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder
SenST-Plus
1 other identifier
observational
250
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
1 active site
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
CompletedFirst Posted
Study publicly available on registry
April 6, 2020
CompletedStudy Start
First participant enrolled
April 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedMarch 15, 2022
March 1, 2022
1.9 years
April 2, 2020
March 14, 2022
Conditions
Keywords
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.
Obsessive Compulsive Disorder
Individuals previously diagnosed with obsessive compulsive disorder (OCD). Participants must be 18 years of age or older.
Healthy Controls
Individuals with no past or current neurologic or psychiatric illness. Participants must be 18 years of age or older.
Interventions
None - observational study
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Isaacs, MD, MPH
Vanderbilt University Medical Center
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
- 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.
All deidentified participant data collected, study protocol, statistical analysis plan, and informed consent documents will be shared.