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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT04335175

Collaborator

(none)

250

Enrollment

Location

22.5

Actual Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tourette Syndrome Obsessive-Compulsive Disorder Sensory Disorders	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:

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 Design

Study Type:

Observational

Actual Enrollment :

250 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder

Actual Study Start Date :

Apr 14, 2020

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Sensory Gating Inventory [Day 1]
36-item, validated self-report questionnaire assessing sensory gating symptoms, with score range 0-216. Higher scores indicate greater sensory gating impairment.

Secondary Outcome Measures

Dimensional Obsessive Compulsive Scale [Day 1]
20-item, validated self-report questionnaire assessing obsessive compulsive symptoms, with score range 0-80. Higher scores indicate more severe obsessive compulsive symptoms.
Adult Attention Deficit Hyperactivity Disorder Self-Report Screening Scale [Day 1]
6-item, validated self-report questionnaire assessing inattention and hyperactivity symptoms, with raw score range from 0-24. Higher scores indicate greater ADHD symptoms.
Generalized Anxiety Disorder-7 Scale [Day 1]
7-item, validated self-report questionnaire assessing anxiety symptoms, with score range from 0-21. Higher scores indicate more severe anxiety.
Patient Health Questionnaire-9 Scale [Day 1]
9-item, validated self-report questionnaire assessing depression symptoms, with score range from 0-27. Higher scores indicate more severe depression.
Premonitory Urge to Tic Scale (for Tourette syndrome patients only) [Day 1]
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.
Adult Tic Questionnaire (for Tourette syndrome patients only) [Day 1]
27-item, validated self-report questionnaire assessing frequency and severity of tics, with score range from 54-216. Higher scores indicate greater tic burden.
WHO Quality of Life - BREF [Day 1]
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.