Tourette SyndromeSenST-PlusNCT04335175
Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder
An observational study of Tourette Syndrome and Obsessive-Compulsive Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome, Obsessive-Compulsive Disorder, Sensory Disorders
- What is being tested?
- None - observational study
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2020to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- age 18 years or older
- previous diagnosis of Tourette syndrome and/or obsessive compulsive disorder
- 18 years of age or older
Who cannot join
- none
- history of any neurologic or psychiatric diagnoses
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-5400
About this study
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.
Read the 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.
- Being tested
- None - observational study
- Keywords
- sensory dysregulation, sensory gating dysfunction, tic, obsessive compulsive, sensory symptom
- Medical subject headings
- Tourette Syndrome, Obsessive-Compulsive Disorder, Sensation Disorders, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - observational studyOther
None - observational study
| Study group | Role | What they receive |
|---|---|---|
| Tourette Syndrome | Individuals previously diagnosed with Tourette syndrome (TS). Participants must be 18 years of age or older. Receives: Other: None - observational study | |
| Obsessive Compulsive Disorder | Individuals previously diagnosed with obsessive compulsive disorder (OCD). Participants must be 18 years of age or older. Receives: Other: None - observational study | |
| Healthy Controls | Individuals with no past or current neurologic or psychiatric illness. Participants must be 18 years of age or older. Receives: Other: None - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start14 Apr 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Isaacs, Vanderbilt University Medical Center
- Investigators
- David Isaacs, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335175
- Sponsor's protocol ID
- 200502
- Acronym
- SenST-Plus
- Status last verified
- Mar 2022
- First submitted
- 2 Apr 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified participant data collected, study protocol, statistical analysis plan, and informed consent documents will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT04335175
- Acronym / sponsor ID
- SenST-Plus / 200502
- Keywords
- sensory dysregulation, sensory gating dysfunction, tic, obsessive compulsive, sensory symptom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tourette Syndrome | – | Other: None - observational studyIndividuals previously diagnosed with Tourette syndrome (TS). Participants must be 18 years of age or older. |
| Obsessive Compulsive Disorder | – | Other: None - observational studyIndividuals previously diagnosed with obsessive compulsive disorder (OCD). Participants must be 18 years of age or older. |
| Healthy Controls | – | Other: None - observational studyIndividuals with no past or current neurologic or psychiatric illness. Participants must be 18 years of age or older. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- age 18 years or older
- previous diagnosis of Tourette syndrome and/or obsessive compulsive disorder
- 18 years of age or older
Key exclusion criteria (2 listed)
- none
- history of any neurologic or psychiatric diagnoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None - observational studyNone - observational study | Other | Healthy Controls, Obsessive Compulsive Disorder, Tourette Syndrome |
Primary outcome
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.
7 secondary outcomes
Dimensional Obsessive Compulsive Scale
Time frame: Day 1
Adult Attention Deficit Hyperactivity Disorder Self-Report Screening Scale
Time frame: Day 1
Generalized Anxiety Disorder-7 Scale
Time frame: Day 1
Patient Health Questionnaire-9 Scale
Time frame: Day 1
Premonitory Urge to Tic Scale (for Tourette syndrome patients only)
Time frame: Day 1
Adult Tic Questionnaire (for Tourette syndrome patients only)
Time frame: Day 1
WHO Quality of Life - BREF
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: Yes. All deidentified participant data collected, study protocol, statistical analysis plan, and informed consent documents will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Isaacs, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourette Syndrome and Obsessive-Compulsive Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Gating Inventory (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.