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MRI Study of Tic Remission in Tourette Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Utah.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT01405859
First received: May 27, 2011
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

Doctors provide a ray of hope to children and their parents with the knowledge that, for most patients, symptoms of Tourette syndrome improve by the time they are young adults. The investigators do not know why some improve and others do not. This study is designed to help answer that question. The investigators will use magnetic resonance imaging (MRI) techniques to test whether individuals who experience improvement of their Tourette's (tic remission) have more mature brain connections than those who do not.


Condition
Tourette Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Neuroimaging to Elucidate the Mechanism of Tic Resolution in Tourette Syndrome

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
TS controls
Non TS Controls
TS remission

Detailed Description:

One of the most interesting aspects of Tourette syndrome is a virtual remission of tics by early adulthood in about half of patients. Information is needed to clarify the mechanism of tic remission in order to guide development of better treatments for this disabling condition. For this cross-sectional study, 10 individuals with tic remission and 10 individuals with persistent Tourette syndrome are being recruited for a one-time study visit. 10 neurologically normal (non-TS) controls have also been recruited to obtain control neuroimaging data. All participants will complete a study questionnaire and a 60-minute MRI procedure. Sequences used to compare the groups will be volumetric, diffusion tensor, resting state functional connectivity MRI and MR spectroscopy. Our primary hypothesis is that the pattern of functional connectivity in individuals with tic remission will be more mature than that of those with persistent tics. Secondary hypotheses tested will explore whether the other modalities can be used to differentiate tic remission from persistent TS.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Young adult males (aged 18-35) with a history of Tourette syndrome, including at least moderate disability from tics during childhood.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405859

Contacts
Contact: David Shprecher 801-585-9386 David.Shprecher@hsc.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: David Shprecher, DO    801-581-4543    david.shprecher@hsc.utah.edu   
Principal Investigator: David Shprecher, DO         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: David Shprecher Neurology
  More Information

Additional Information:
No publications provided

Responsible Party: Assistant Professor David Shprecher, Neurology
ClinicalTrials.gov Identifier: NCT01405859     History of Changes
Other Study ID Numbers: 39432
Study First Received: May 27, 2011
Last Updated: June 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Tourette
tic
Tourette's
Tourette syndrome
Tourette's syndrome

Additional relevant MeSH terms:
Tourette Syndrome
Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Disease
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Mental Disorders Diagnosed in Childhood
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Pathologic Processes
Tic Disorders

ClinicalTrials.gov processed this record on November 20, 2014