- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01405859
MRI Study of Tic Remission in Tourette Syndrome
Neuroimaging to Elucidate the Mechanism of Tic Resolution in Tourette Syndrome
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84108
- University of Utah
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
All subjects: males aged 18-35 with history of Tourette syndrome and at least moderately disabling tics during childhood.
Persistent Tourette's subjects: history of disabling tics during childhood but no longer taking tic suppressing drugs.
Tic remission subjects: no longer experiencing any disability (even social discomfort) from tics. Must have had sustained improvement of tics for at least 3 years.
Normal controls: no longer recruiting.
Exclusion Criteria:
Tourette's subjects still taking tic suppressing drugs are excluded. Also excluded are any patients with a condition (such as a pacemaker, recent tattoo, implantable metal device, or claustrophobia) that could make the MRI examination unsafe.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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TS controls
10
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Non TS Controls
11
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TS remission
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Resting state functional connectivity
Time Frame: Participants come in for a one-time visit. All participants will be enrolled by July 2012. Data will be analyzed by Sept 2012.
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Quantitative measurements of integrated voxel-by-voxel blood oxygen level dependent fMRI time-series data will be compared between activated regions.
Cross-correlation coefficients will be computed following band-pass filtering of data for evaluation of frequency-dependent contributions to correlation using standard functional connectivity techniques.
Similar correlation analysis will be performed with signal from pulse oximetry and respiratory effort to evaluate for confounding stimulus-correlated physiological noise.
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Participants come in for a one-time visit. All participants will be enrolled by July 2012. Data will be analyzed by Sept 2012.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Magnetic resonance spectroscopy
Time Frame: Participants come in for a one-time visit. All participants will be enrolled by July 2012. Data will be analyzed by Sept 2012.
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For each subject a central voxel within the anterior cingulate will be used as the region of interest.
Peaks for substances of interest will be compared between each cohort.
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Participants come in for a one-time visit. All participants will be enrolled by July 2012. Data will be analyzed by Sept 2012.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Shprecher, Neurology
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Tic Disorders
- Syndrome
- Tourette Syndrome
Other Study ID Numbers
- 39432
Plan for Individual participant data (IPD)
Study Data/Documents
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Clinical Study Report
Information comments: Final Study Results, Published in Tremor and Other Hyperkinetic Disorders
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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