MRI Study of Tic Remission in Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

Neuroimaging to Elucidate the Mechanism of Tic Resolution in Tourette Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01405859
• Other study ID #: 39432
• Status: Recruiting
• Phase: N/A
• First received: May 27, 2011
• Last updated: June 1, 2012
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: University of Utah
• Contact: David Shprecher
• Phone: 801-585-9386
• Email: David.Shprecher[@]hsc.utah.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting state functional connectivity	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.	Participants come in for a one-time visit. All participants will be enrolled by July 2012. Data will be analyzed by Sept 2012.	No
Secondary	Magnetic resonance spectroscopy	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.	Participants come in for a one-time visit. All participants will be enrolled by July 2012. Data will be analyzed by Sept 2012.	No

External Links

•   Utah Tourette program webpage