NCT01405859

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Typical duration 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

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

2.4 years

First QC Date

May 27, 2011

Last Update Submit

May 10, 2016

Conditions

Tourette Syndrome

Keywords

TouretteticTourette'sTourette syndromeTourette's syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Magnetic resonance spectroscopy

    Participants come in for a one-time visit. All participants will be enrolled by July 2012. Data will be analyzed by Sept 2012.

Study Arms (3)

TS controls

10

Non TS Controls

11

TS remission

0

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Tourette SyndromeTics

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

Study Officials

  • David Shprecher

    Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Neurology

Study Record Dates

First Submitted

May 27, 2011

First Posted

July 29, 2011

Study Start

January 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

US(1)