Sensory Processing in Tourette Syndrome
1 other identifier
observational
18
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2015
CompletedFirst Posted
Study publicly available on registry
July 30, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2016
CompletedApril 28, 2017
April 1, 2017
5 months
July 29, 2015
April 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
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.
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.
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.
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.
Day 1
Study Arms (1)
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.
Interventions
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.
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.
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.
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.
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.
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.
Eligibility Criteria
Targeted study population includes patients 6-18 diagnosed with Tourette Syndrome who are a patient of University of Florida Movement Disorders Center.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UF Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irene Malaty, M.D.
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2015
First Posted
July 30, 2015
Study Start
August 1, 2015
Primary Completion
January 1, 2016
Study Completion
June 2, 2016
Last Updated
April 28, 2017
Record last verified: 2017-04