Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder (SenST-Plus)

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Tourette Syndrome; Sensory Disorders
• Intervention / Treatment: Other: None - observational study

Detailed Description

Tourette syndrome (TS) is a neurodevelopmental disorder affecting 1% of school-aged children, with one-third of patients suffering persistent tics into adulthood. Obsessive-compulsive disorder (OCD) is a common comorbidity with TS. Individuals with either TS or OCD frequently exhibit sensory dysregulation, manifesting as heightened awareness of internal and external stimuli. For patients with OCD, sensory dysregulation has been linked to obsessive-compulsive symptoms and is an important consideration in treatment strategies. Sensory dysregulation remains largely unexplored in TS, but preliminary data suggests it is dissociable from tics, linked with obsessive-compulsive symptoms, and associated with poorer quality of life (QOL). This study seeks to address two key questions related to sensory dysregulation in TS and 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? To do so, we will recruit patients with TS, patients with OCD, and healthy controls to complete an online battery of validated questionnaires assessing sensory dysregulation, psychiatric symptoms, and QOL. Addressing these knowledge gaps will enhance our understanding of bothersome sensory symptoms in TS and OCD, shed light on clinical overlap and/or distinctions between these commonly co-occurring psychiatric diagnoses, and clarify QOL impact and the potential need for more direct targeting of these symptoms.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-5400
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion criteria for the patient groups:

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

Exclusion criteria for the patient groups:

- none

Inclusion criteria for healthy controls includes:

- 18 years of age or older

Exclusion criteria for the patient groups:

- history of any neurologic or psychiatric diagnoses

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tourette Syndrome; Individuals previously diagnosed with Tourette syndrome (TS). Participants must be 18 years of age or older.	Other: None - observational study; 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; 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; None - observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dimensional Obsessive Compulsive Scale	20-item, validated self-report questionnaire assessing obsessive compulsive symptoms, with score range 0-80. Higher scores indicate more severe obsessive compulsive symptoms.	Day 1
Adult Attention Deficit Hyperactivity Disorder Self-Report Screening Scale	6-item, validated self-report questionnaire assessing inattention and hyperactivity symptoms, with raw score range from 0-24. Higher scores indicate greater ADHD symptoms.	Day 1
Generalized Anxiety Disorder-7 Scale	7-item, validated self-report questionnaire assessing anxiety symptoms, with score range from 0-21. Higher scores indicate more severe anxiety.	Day 1
Patient Health Questionnaire-9 Scale	9-item, validated self-report questionnaire assessing depression symptoms, with score range from 0-27. Higher scores indicate more severe depression.	Day 1
Premonitory Urge to Tic Scale (for Tourette syndrome patients only)	10-item, validated self-report questionnaire assessing premonitory urge symptoms, with score range from 9-36. Higher scores indicate more severe premonitory urge prior to tics.	Day 1
Adult Tic Questionnaire (for Tourette syndrome patients only)	27-item, validated self-report questionnaire assessing frequency and severity of tics, with score range from 54-216. Higher scores indicate greater tic burden.	Day 1
WHO Quality of Life - BREF	26-item, validated self-report questionnaire assessing 4 domains of health: physical, psychological, social, and environmental. 54-216. Higher scores indicate greater tic burden. Scores range from 0-100 within each domain. Higher scores indicate better quality of life.	Day 1

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: David Isaacs, MD, MPH, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 14, 2020
• Primary Completion (ACTUAL): February 28, 2022
• Study Completion (ACTUAL): February 28, 2022

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (ACTUAL): April 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: tic; sensory dysregulation; sensory gating dysfunction; obsessive compulsive; sensory symptom
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Personality Disorders; Anxiety Disorders; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Tourette Syndrome; Sensation Disorders
• Other Study ID Numbers: 200502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All deidentified participant data collected, study protocol, statistical analysis plan, and informed consent documents will be shared.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No