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Completed

NCT Number: NCT04335175

Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

None - observational study

Other

None - observational study

Primary outcomes

  1. Sensory Gating Inventory

    Time frame: 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 outcomes

  1. Dimensional Obsessive Compulsive Scale

    Time frame: 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.

  2. Adult Attention Deficit Hyperactivity Disorder Self-Report Screening Scale

    Time frame: 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.

  3. Generalized Anxiety Disorder-7 Scale

    Time frame: Day 1

    7-item, validated self-report questionnaire assessing anxiety symptoms, with score range from 0-21. Higher scores indicate more severe anxiety.

  4. Patient Health Questionnaire-9 Scale

    Time frame: Day 1

    9-item, validated self-report questionnaire assessing depression symptoms, with score range from 0-27. Higher scores indicate more severe depression.

  5. Premonitory Urge to Tic Scale (for Tourette syndrome patients only)

    Time frame: 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.

  6. Adult Tic Questionnaire (for Tourette syndrome patients only)

    Time frame: 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.

  7. WHO Quality of Life - BREF

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: SenST-Plus

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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