Tourette SyndromeNCT02512406
Sensory Processing in Tourette Syndrome
An observational study of Tourette Syndrome, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to learn more about how patients with Tourette Syndrome deal with sensory stimuli in their environment such as bright lights, loud noises, physical sensations such as shirt tags, etcetera. We will compare responses of patients with Tourette Syndrome to those without Tourette Syndrome. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- The Sensory Profile, The Adult/Adolescent Sensory Profile and Children's Yale-Brown Obsessive Compulsive Scale
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 2 Jun 2016
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Targeted study population includes patients 6-18 diagnosed with Tourette Syndrome who are a patient of University of Florida Movement Disorders Center.
Who may be able to join
- Targeted study population includes patients diagnosed with Tourette Syndrome
- Patient of University of Florida Movement Disorders Center diagnosed with Tourette Syndrome by a movement disorder specialist, according to DSM IV diagnostic criteria
- Age 6-18
- Presence of parent or guardian able to provide consent in the case of minors
Who cannot join
- Inability of patient or, in the case of minors, parent/guardian to provide informed consent
- Inability of designated person to complete questionnaires. In the case of patients' age 10 and younger, this would refer to the parent/guardian. In the case of patients older than 10, this could be either the patient or their parent/guardian
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607
About this study
The purpose of this study is to learn more about how patients with Tourette Syndrome deal with sensory stimuli in their environment such as bright lights, loud noises, physical sensations such as shirt tags, etcetera. We will compare responses of patients with Tourette Syndrome to those without Tourette Syndrome.
The study aims to better characterize sensory processing abnormalities by sensory modality: The investigators will use a measuring tool based on Dunn's 1997 model of sensory processing, the Sensory Profile, which will allow the investigator to characterize both registration and response to external stimuli, as well as to delineate which sensory modalities are affected. Identifying which sensory modalities are most affected may guide future research into the pathophysiology of sensory processing abnormalities in TS.
The investigators also aim to correlate sensory processing abnormalities with the presence of Obsessive Compulsive Disorder (OCD), Attention-deficit/hyperactivity disorder (ADHD) , and autism spectrum disorders.
Read the detailed description
While it is widely recognized that patients with tic and Tourette Syndrome (TS) experience heightened sensitivity to or abnormal processing of internal sensations, it has also been suggested that patients with tic and TS experience abnormal processing of external sensations/stimuli. While this sensitivity to external stimuli does not appear to trigger motor or vocal tics, it can significantly affect quality of life. These sensitivities can be a source of irritation, discomfort, and distraction that can be equally or more disruptive than vocal or motor tics. Heightened sensitivity to external stimuli or other abnormalities of external sensory processing have been identified in other neuropsychological disorders such as autism spectrum disorders, schizophrenia, traumatic brain injury, ADHD, and obsessive-compulsive disorder (OCD) . TS often presents with co-morbid diagnoses including attention-deficit and hyperactivity disorder (ADHD) and obsessive-compulsive disorder (OCD) but it is not currently known whether sensitivity to external stimuli is due to a central processing abnormality common to these disorders.
This study's objective is to use a variety of questionnaires to determine how external stimuli along with the presence of other disorders effect sensory processing.
- Conditions
- Tourette Syndrome
- Being tested
- The Sensory Profile, The Adult/Adolescent Sensory Profile, Children's Yale-Brown Obsessive Compulsive Scale, Yale-Brown Obsessive Compulsive Scale, Yale Global Tic Severity Scale
- Keywords
- Tourette Syndrome, Tics
- Medical subject headings
- Tourette Syndrome, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Sensory ProfileOther
60 item questionnaire administered to participants age 6-10 with questions pertaining to sensory processing categories of Taste/Smell, Movement, Visual, Touch, Activity Level, and Auditory. Scores are tallied for each category. Results are plotted along an x and y-axis with one axis being perception or stimulus (low registration to sensory sensitivity) and the other being response to stimulus (sensation seeking to sensation avoiding). Each category is plotted along this axis and compared to normative data which is included in this tool.
The Adult/Adolescent Sensory ProfileOther
60 item questionnaire administered to participants age 11 and older with questions pertaining to sensory processing categories of Taste/Smell, Movement, Visual, Touch, Activity Level, and Auditory. Scores are tallied for each category. Results are plotted along an x and y-axis with one axis being perception or stimulus (low registration to sensory sensitivity) and the other being response to stimulus (sensation seeking to sensation avoiding). Each category is plotted along this axis and compared to normative data which is included in this tool.
Children's Yale-Brown Obsessive Compulsive ScaleOther
10-item symptom checklist questionnaire administered by a physician to participants aged 6-14. 1st part is a yes/no checklist of obsessions (1-42) and compulsions (43-67) experienced in the past or present. 2nd part is a scored severity scale with 10 questions in which they assign a 0-4 severity score which is summed for a total score.
Yale-Brown Obsessive Compulsive ScaleOther
10-item symptom checklist questionnaire administered by a physician to participants aged 15 and older. 1st part is a yes/no checklist of obsessions (1-42) and compulsions (43-67) experienced in the past or present. 2nd part is a scored severity scale with 10 questions in which they assign a 0-4 severity score which is summed for a total score.
Yale Global Tic Severity ScaleOther
Clinician administered questionnaire given to all participants. Part 1 asks about 10 types of motor tics, 12 types of vocal tics (current, ever, age of onset, description). Part 2 is a severity rating that scores both motor and vocal tics on a 0-5 scale for each severity item: number of tics, intensity, frequency, complexity, interference, impairment. Totals are summed for all items.
Demographic DataOther
Data will be collected including: Age, duration of symptoms, presence or absence of autism spectrum disorder, presence or absence of OCD, presence or absence of ADHD.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Tourette Syndrome | Questionnaires including the Sensory Profile or the Adult/Adolescent Sensory profile and Children's Yale-Brown Obsessive Compulsive Scale or Yale Global Tic Severity Scale will be administered. When time permits, the Children's Yale-Brown Obsessive Compulsive Scale or Yale-Brown Obsessive Compulsive Scale will also be administered. Demographic data will also be collected for each study patient. Receives: Other: The Sensory Profile; Other: The Adult/Adolescent Sensory Profile; Other: Children's Yale-Brown Obsessive Compulsive Scale; Other: Yale-Brown Obsessive Compulsive Scale; Other: Yale Global Tic Severity Scale; Other: Demographic Data |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Sensory Profile
60 item questionnaire administered to participants age 6-10 with questions pertaining to sensory processing categories of Taste/Smell, Movement, Visual, Touch, Activity Level, and Auditory. Scores are tallied for each category. Results are plotted along an x and y-axis with one axis being perception or stimulus (low registration to sensory sensitivity) and the other being response to stimulus (sensation seeking to sensation avoiding). Each category is plotted along this axis and compared to normative data which is included in this tool.
Measured: Day 1
The Adult/Adolescent Sensory Profile
60 item questionnaire administered to participants age 11 and older with questions pertaining to sensory processing categories of Taste/Smell, Movement, Visual, Touch, Activity Level, and Auditory. Scores are tallied for each category. Results are plotted along an x and y-axis with one axis being perception or stimulus (low registration to sensory sensitivity) and the other being response to stimulus (sensation seeking to sensation avoiding). Each category is plotted along this axis and compared to normative data which is included in this tool.
Measured: Day 1
Children's Yale-Brown Obsessive Compulsive Scale
10-item symptom checklist questionnaire administered by a physician to participants aged 6-14. 1st part is a yes/no checklist of obsessions (1-42) and compulsions (43-67) experienced in the past or present. 2nd part is a scored severity scale with 10 questions in which they assign a 0-4 severity score which is summed for a total score.
Measured: Day 1
Yale-Brown Obsessive Compulsive Scale
10-item symptom checklist questionnaire administered by a physician to participants aged 15 and older. 1st part is a yes/no checklist of obsessions (1-42) and compulsions (43-67) experienced in the past or present. 2nd part is a scored severity scale with 10 questions in which they assign a 0-4 severity score which is summed for a total score.
Measured: Day 1
Yale Global Tic Severity Scale
Clinician administered questionnaire given to all participants. Part 1 asks about 10 types of motor tics, 12 types of vocal tics (current, ever, age of onset, description). Part 2 is a severity rating that scores both motor and vocal tics on a 0-5 scale for each severity item: number of tics, intensity, frequency, complexity, interference, impairment. Totals are summed for all items.
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 posted30 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2016
- Study completion2 Jun 2016
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 University of FloridaThe 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Malaty, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512406
- Sponsor's protocol ID
- IRB201400293
- Status last verified
- Apr 2017
- First submitted
- 29 Jul 2015
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Processing in Tourette Syndrome
- ClinicalTrials.gov ID
- NCT02512406
- Acronym / sponsor ID
- IRB201400293
- Conditions
- Tourette Syndrome
- Keywords
- Tourette Syndrome, Tics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- 2 Jun 2016 (actual)
- First posted
- 30 Jul 2015 (estimated)
- 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.
The purpose of this study is to learn more about how patients with Tourette Syndrome deal with sensory stimuli in their environment such as bright lights, loud noises, physical sensations such as shirt tags, etcetera. We will compare responses of patients with Tourette Syndrome to those without Tourette Syndrome.
The study aims to better characterize sensory processing abnormalities by sensory modality: The investigators will use a measuring tool based on Dunn's 1997 model of sensory processing, the Sensory Profile, which will allow the investigator to characterize both registration and response to external stimuli, as well as to delineate which sensory modalities are affected. Identifying which sensory modalities are most affected may guide future research into the pathophysiology of sensory processing abnormalities in TS.
The investigators also aim to correlate sensory processing abnormalities with the presence of Obsessive Compulsive Disorder (OCD), Attention-deficit/hyperactivity disorder (ADHD) , and autism spectrum disorders.
Detailed description
While it is widely recognized that patients with tic and Tourette Syndrome (TS) experience heightened sensitivity to or abnormal processing of internal sensations, it has also been suggested that patients with tic and TS experience abnormal processing of external sensations/stimuli. While this sensitivity to external stimuli does not appear to trigger motor or vocal tics, it can significantly affect quality of life. These sensitivities can be a source of irritation, discomfort, and distraction that can be equally or more disruptive than vocal or motor tics. Heightened sensitivity to external stimuli or other abnormalities of external sensory processing have been identified in other neuropsychological disorders such as autism spectrum disorders, schizophrenia, traumatic brain injury, ADHD, and obsessive-compulsive disorder (OCD) . TS often presents with co-morbid diagnoses including attention-deficit and hyperactivity disorder (ADHD) and obsessive-compulsive disorder (OCD) but it is not currently known whether sensitivity to external stimuli is due to a central processing abnormality common to these disorders.
This study's objective is to use a variety of questionnaires to determine how external stimuli along with the presence of other disorders effect sensory processing.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Tourette Syndrome | – | Other: The Sensory Profile, Other: The Adult/Adolescent Sensory Profile, Other: Children's Yale-Brown Obsessive Compulsive Scale, Other: Yale-Brown Obsessive Compulsive Scale, Other: Yale Global Tic Severity Scale, Other: Demographic DataQuestionnaires including the Sensory Profile or the Adult/Adolescent Sensory profile and Children's Yale-Brown Obsessive Compulsive Scale or Yale Global Tic Severity Scale will be administered. When time permits, the Children's Yale-Brown Obsessive Compulsive Scale or Yale-Brown Obsessive Compulsive Scale will also be administered. Demographic data will also be collected for each study patient. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Targeted study population includes patients 6-18 diagnosed with Tourette Syndrome who are a patient of University of Florida Movement Disorders Center.
Key inclusion criteria (4 listed)
- Targeted study population includes patients diagnosed with Tourette Syndrome
- Patient of University of Florida Movement Disorders Center diagnosed with Tourette Syndrome by a movement disorder specialist, according to DSM IV diagnostic criteria
- Age 6-18
- Presence of parent or guardian able to provide consent in the case of minors
Key exclusion criteria (2 listed)
- Inability of patient or, in the case of minors, parent/guardian to provide informed consent
- Inability of designated person to complete questionnaires. In the case of patients' age 10 and younger, this would refer to the parent/guardian. In the case of patients older than 10, this could be either the patient or their parent/guardian
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 |
|---|---|---|
| The Sensory Profile60 item questionnaire administered to participants age 6-10 with questions pertaining to sensory processing categories of Taste/Smell, Movement, Visual, Touch, Activity Level, and Auditory. Scores are tallied for each category. Results are plotted along an x and y-axis with one axis being perception or stimulus (low registration to sensory sensitivity) and the other being response to stimulus (sensation seeking to sensation avoiding). Each category is plotted along this axis and compared to normative data which is included in this tool. | Other | Patients with Tourette Syndrome |
| The Adult/Adolescent Sensory Profile60 item questionnaire administered to participants age 11 and older with questions pertaining to sensory processing categories of Taste/Smell, Movement, Visual, Touch, Activity Level, and Auditory. Scores are tallied for each category. Results are plotted along an x and y-axis with one axis being perception or stimulus (low registration to sensory sensitivity) and the other being response to stimulus (sensation seeking to sensation avoiding). Each category is plotted along this axis and compared to normative data which is included in this tool. | Other | Patients with Tourette Syndrome |
| Children's Yale-Brown Obsessive Compulsive Scale10-item symptom checklist questionnaire administered by a physician to participants aged 6-14. 1st part is a yes/no checklist of obsessions (1-42) and compulsions (43-67) experienced in the past or present. 2nd part is a scored severity scale with 10 questions in which they assign a 0-4 severity score which is summed for a total score. | Other | Patients with Tourette Syndrome |
| Yale-Brown Obsessive Compulsive Scale10-item symptom checklist questionnaire administered by a physician to participants aged 15 and older. 1st part is a yes/no checklist of obsessions (1-42) and compulsions (43-67) experienced in the past or present. 2nd part is a scored severity scale with 10 questions in which they assign a 0-4 severity score which is summed for a total score. | Other | Patients with Tourette Syndrome |
| Yale Global Tic Severity ScaleClinician administered questionnaire given to all participants. Part 1 asks about 10 types of motor tics, 12 types of vocal tics (current, ever, age of onset, description). Part 2 is a severity rating that scores both motor and vocal tics on a 0-5 scale for each severity item: number of tics, intensity, frequency, complexity, interference, impairment. Totals are summed for all items. | Other | Patients with Tourette Syndrome |
| Demographic DataData will be collected including: Age, duration of symptoms, presence or absence of autism spectrum disorder, presence or absence of OCD, presence or absence of ADHD. | Other | Patients with Tourette Syndrome |
Primary outcome
The Sensory Profile
Time frame: Day 1
60 item questionnaire administered to participants age 6-10 with questions pertaining to sensory processing categories of Taste/Smell, Movement, Visual, Touch, Activity Level, and Auditory. Scores are tallied for each category. Results are plotted along an x and y-axis with one axis being perception or stimulus (low registration to sensory sensitivity) and the other being response to stimulus (sensation seeking to sensation avoiding). Each category is plotted along this axis and compared to normative data which is included in this tool.
The Adult/Adolescent Sensory Profile
Time frame: Day 1
60 item questionnaire administered to participants age 11 and older with questions pertaining to sensory processing categories of Taste/Smell, Movement, Visual, Touch, Activity Level, and Auditory. Scores are tallied for each category. Results are plotted along an x and y-axis with one axis being perception or stimulus (low registration to sensory sensitivity) and the other being response to stimulus (sensation seeking to sensation avoiding). Each category is plotted along this axis and compared to normative data which is included in this tool.
Children's Yale-Brown Obsessive Compulsive Scale
Time frame: Day 1
10-item symptom checklist questionnaire administered by a physician to participants aged 6-14. 1st part is a yes/no checklist of obsessions (1-42) and compulsions (43-67) experienced in the past or present. 2nd part is a scored severity scale with 10 questions in which they assign a 0-4 severity score which is summed for a total score.
Yale-Brown Obsessive Compulsive Scale
Time frame: Day 1
10-item symptom checklist questionnaire administered by a physician to participants aged 15 and older. 1st part is a yes/no checklist of obsessions (1-42) and compulsions (43-67) experienced in the past or present. 2nd part is a scored severity scale with 10 questions in which they assign a 0-4 severity score which is summed for a total score.
Yale Global Tic Severity Scale
Time frame: Day 1
Clinician administered questionnaire given to all participants. Part 1 asks about 10 types of motor tics, 12 types of vocal tics (current, ever, age of onset, description). Part 2 is a severity rating that scores both motor and vocal tics on a 0-5 scale for each severity item: number of tics, intensity, frequency, complexity, interference, impairment. Totals are summed for all items.
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 28 Apr 2017.
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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.
Irene Malaty, M.D. principal investigator
University of Florida
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, run by University of Florida 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 4 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 28 Apr 2017. 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?
The Sensory Profile (time frame: Day 1). The study lists 5 primary outcomes in all. 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 28 Apr 2017.