Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

— SenST-Plus  

Official title:

Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04335175
• Other study ID #: 200502
• Status: Completed
• Start date: April 14, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Obsessive-Compulsive Disorder
• Sensation Disorders
• Sensory Disorders
• Syndrome
• Tourette Syndrome

Intervention

Other:
• None - observational study
None - observational study

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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