NCT00141869

Brief Summary

This study will examine brain activity associated with the involuntary urges or uncontrolled movements, called "tics," experienced by people who have Tourette syndrome (TS). Before people with TS actually develop a tic, whether it is a movement or a vocal tic (like a cough or bark), they feel the urge to tic. This study will look at brain activity during the time of this urge and how brain activity may differ in people with TS and without TS. Healthy normal volunteers and patients with TS between 14 and 65 years of age may be eligible for this study. Patients must have sensory tics in the facial region and must experience at least a moderate premonitory urge. Candidates are screened with a medical history, brief physical examination, and a questionnaire. Participants undergo the following procedures:

  • Magnetoencephalography (MEG): This test records magnetic field changes produced by brain activity. During the test, the subjects are seated in the MEG recording room and a cone containing magnetic field detectors is lowered onto their head. Electrodes (small metal disks) are placed on both sides of the face near the jaw. The recording may be made while the subject receives small currents from the electrodes on the jaw. Subjects may be asked a few questions about what they felt during the procedure.
  • Magnetic resonance imaging (MRI): This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. During the procedure, the subject lies on a table that can slide in and out of the scanner-a metal cylinder. Subjects may be asked to lie still for up to 30 minutes at a time. They can communicate with the staff at any time during the scan.
  • Somatosensory evoked responses: This test examines how sensory information travels form the nerves to the spinal cord and brain in the nervous system. An electrode placed on the arm, leg, or face delivers a small electrical stimulus that may tingle and cause a twitch of a hand, foot, or face muscle. Additional electrodes may sometimes be placed on the scalp, neck, and over the collarbone to record how the impulse from the stimulus travels over nerve pathways. Patients in the study are contacted for follow-up after the study. Follow-up will be conducted by phone or email, according to the patients' convenience, and will consist of reaffirming that there were no adverse events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2005

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

August 30, 2005

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2007

Completed
Last Updated

July 2, 2017

Status Verified

September 6, 2007

First QC Date

August 31, 2005

Last Update Submit

June 30, 2017

Conditions

Keywords

Sensory ProcessingMagnetoencephalogramTourete SyndromeTrigeminal NerveTicsTSHealthy VolunteerHV

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be normal volunteers with no history of neurological disorders; they will be screened in the NINDS Movement Disorders Outpatient Clinic, and will have a neurological and physical examination.
  • Subjects will be male or female, in age ranges 14 to 65 years old.
  • Patients ages 14 to 65 with a clinical diagnosis of tourette syndrome or chronic motor tic disorder as defined by DSM-IV-TR and evaluation of tic severity using the Yale Tic Scale (YGTSS). 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 subjects 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.
  • Patients with sensory tics, either bilaterally or unilaterally, in the facial region.

You may not qualify if:

  • Cardiac pacemaker / cardiac or neural defibrillators.
  • Metal fragments in the eyes.
  • Metal plates, pins, or bolts in the head.
  • Any magnetic implantation / implantations made from iron (ferrous products).
  • Hearing problems.
  • Problems using response devices.
  • Subjects younger than 14 or older than 65 years.
  • Subjects with 1 ) major depression, 2) bipolar disorder, or 3) psychotic disorder.
  • Subjects taking benzodiazepines, anti-depressant or neuroleptic medications.
  • Subjects with major acute or chronic illness, or subjects for whom sitting in a still position for an extended period of time would trigger or exacerbate a preexisting condition or cause any undue harm or discomfort.
  • Pregnant women (steroidal hormones have been shown to influence EEG (Rupprecht et al., 2001).
  • Patients with severe head tics or subjects who are unable to hold their head still in a scanner for at least 70 seconds.

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 (1)

  • 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

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 Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 1, 2005

Study Start

August 30, 2005

Study Completion

September 6, 2007

Last Updated

July 2, 2017

Record last verified: 2007-09-06

Locations