An observational study in Tourette Syndrome, Obsessive-Compulsive Disorder and Sensory Disorders, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Vanderbilt University Medical Center · Observational
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.
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.
220 studies on the registry are indexed under Tourette Syndrome; 37 are open to participants now.
This study's enrollment of 250 is above the median of 60 across 43 observational studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
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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.
Inclusion criteria for the patient groups:
Exclusion criteria for the patient groups:
Inclusion criteria for healthy controls includes:
Exclusion criteria for the patient groups:
Individuals previously diagnosed with Tourette syndrome (TS). Participants must be 18 years of age or older.
Other: None - observational study
Individuals previously diagnosed with obsessive compulsive disorder (OCD). Participants must be 18 years of age or older.
Other: None - observational study
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
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.
Time frame: Day 1
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1
Plan to share: Yes — All deidentified participant data collected, study protocol, statistical analysis plan, and informed consent documents will be shared.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center