Clinical trial NCT04335175: Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder
Official title: Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tourette Syndrome
Obsessive-Compulsive Disorder
Sensory Disorders
Keywords: sensory dysregulation
sensory gating dysfunction
tic
obsessive compulsive
sensory symptom
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensory Gating Inventory
timeFrame: Day 1
Secondary outcomes:
measure: Dimensional Obsessive Compulsive Scale
timeFrame: Day 1
measure: Adult Attention Deficit Hyperactivity Disorder Self-Report Screening Scale
timeFrame: Day 1
measure: Generalized Anxiety Disorder-7 Scale
timeFrame: Day 1
measure: Patient Health Questionnaire-9 Scale
timeFrame: Day 1
measure: Premonitory Urge to Tic Scale (for Tourette syndrome patients only)
timeFrame: Day 1
measure: Adult Tic Questionnaire (for Tourette syndrome patients only)
timeFrame: Day 1
measure: WHO Quality of Life - BREF
timeFrame: Day 1
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David Isaacs, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: