NCT00368433

Brief Summary

This study will investigate how the sensitivity to touch and smell in patients with Tourette syndrome (TS) may differ from that of people without TS. TS is a neurological disorder that causes people to have uncontrolled movements called "tics." A tic can also be vocal, like a cough or bark or string of bad words. The tic is preceded by a "premonitory urge" that may feel like an itch or pressure that builds until the tic occurs. To some patients, the tic feels like a response to an involuntary sensation. In patients with TS, sensory information may be processed differently than it is in people without TS. This study will compare how strong a sensation feels in TS patients and healthy volunteers. It will also look for muscle activity that may be responsible for the feelings in the area of the tic. Healthy normal volunteers and people with Tourette syndrome, 18 to 65 years of age, may be eligible for this study. Candidates are screened with a medical history and brief physical and neurological examinations. TS patients complete a questionnaire about their tics and are interviewed by a psychiatrist. Women who can become pregnant will have a urine pregnancy test prior to any other procedures. Pregnant women cannot participate. All participants undergo sensory testing for touch and smell. They are asked to distinguish between a scented and scentless object and rate how strongly they feel the scent. Later, with their eyes closed, they are asked to tell whether or not they are being touched, and to rate how intensely they felt the touch. In addition to the sensory testing, TS patients, but not normal volunteers, undergo electromyography (EMG), a test that measures the electrical activity of muscles. For surface EMG, small metal disks called electrodes are filled with a conductive gel and taped to the skin. Wire EMG involves inserting a wire into a muscle using a needle. All patients have surface EMG and those who consent to it will also have wire EMG.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Longer than P75 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

August 21, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2011

Completed
Last Updated

July 2, 2017

Status Verified

May 24, 2011

First QC Date

August 23, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Sensory ProcessingElectromyogramTic DisorderTourette SyndromeTourette's SyndromeHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Volunteers ages 18 to 65 who have who have given their consent.
  • Patients will be ages 18 to 65 and have clinically documented Tourette's syndrome or chronic motor tic disorder as defined by DSM-IV-TR (American Psychiatric Association, 2000) and evaluation of tic severity using the Yale Tic Scale (YGTS). This criterion will be established by preliminary screening in the NINDS Movement Disorders Outpatient Clinic. Structure Clinical Interview for (DSMIV SCID) will be administered to all patients to ensure that strict DSM-IV criteria for Tourette Syndrome have been met and to assess for possible comorbid psychiatric disorders.
  • Patients with at least moderate premonitory urge, as evaluated with the PUTS.

You may not qualify if:

  • Subjects younger than 18 or older than 65 years.
  • Subjects with 1) major depression, 2) bipolar disorder, or 3) psychotic disorder.
  • Subjects who are unable to abstain from alcohol or any psychiatric medications 24 hours prior to the study.
  • Subjects with acute or chronic upper respiratory illness, nasal allergies, or subjects using medications to treat these conditions, including antihistamines, nasal topical steroids, vasoconstrictor nasal sprays, or normal saline sprays.
  • Women who are pregnant.
  • Individuals with Restless Legs syndrome.
  • Individuals with a diagnosis of peripheral neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Bartoshuk LM, Duffy VB, Green BG, Hoffman HJ, Ko CW, Lucchina LA, Marks LE, Snyder DJ, Weiffenbach JM. Valid across-group comparisons with labeled scales: the gLMS versus magnitude matching. Physiol Behav. 2004 Aug;82(1):109-14. doi: 10.1016/j.physbeh.2004.02.033.

    PMID: 15234598BACKGROUND
  • Bliss J. Sensory experiences of Gilles de la Tourette syndrome. Arch Gen Psychiatry. 1980 Dec;37(12):1343-7. doi: 10.1001/archpsyc.1980.01780250029002.

    PMID: 6934713BACKGROUND
  • Garcia-Perez MA. Forced-choice staircases with fixed step sizes: asymptotic and small-sample properties. Vision Res. 1998 Jun;38(12):1861-81. doi: 10.1016/s0042-6989(97)00340-4.

    PMID: 9797963BACKGROUND

MeSH Terms

Conditions

Tourette SyndromeTic Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 23, 2006

First Posted

August 24, 2006

Study Start

August 21, 2006

Study Completion

May 24, 2011

Last Updated

July 2, 2017

Record last verified: 2011-05-24

Locations