NCT02512406

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2016

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

July 29, 2015

Last Update Submit

April 27, 2017

Conditions

Keywords

Tourette SyndromeTics

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.

Other: The Sensory ProfileOther: The Adult/Adolescent Sensory ProfileOther: Children's Yale-Brown Obsessive Compulsive ScaleOther: Yale-Brown Obsessive Compulsive ScaleOther: Yale Global Tic Severity ScaleOther: Demographic Data

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.

Patients with Tourette Syndrome

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.

Patients with Tourette Syndrome

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.

Patients with Tourette Syndrome

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.

Patients with Tourette Syndrome

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.

Patients with Tourette Syndrome

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.

Patients with Tourette Syndrome

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Tourette SyndromeTics

Interventions

Demography

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Irene Malaty, M.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

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

Locations