NCT00026000

Brief Summary

This study will investigate the brain areas that are activated by vocal and motor tics in patients with Tourette's syndrome and other tic disorders. Tics are involuntary repetitive movements similar to voluntary movements. They may be simple, involving only a few muscles or simple sounds, or complex, involving several groups of muscles in orchestrated bouts. This study will involve only simple motor tics, such as eye blinking, nose wrinkling, facial grimacing and abdominal tensing, and simple vocal tics, such as throat clearing, sniffing and snorting. Healthy normal volunteers and patients between 14 and 65 years of age with simple motor or vocal tics may be eligible for this study. Participants will have a brief medical history and physical examination and magnetic resonance imaging (MRI) of the brain. MRI uses a magnetic field and radio waves to produce images. For the procedure, the subject lies on a table that is moved into a cylindrical chamber containing a strong magnet. Earplugs are worn to muffle the loud thumping sounds made by electrical switching of the radio frequency circuits and protect against temporary hearing impairment. During the scan, normal volunteers will be asked to make simple movements or sounds designed to imitate tics, such as raising eyebrows, blinking or coughing. Patients with tic disorders will have two parts to the scanning session. First they will relax and allow tics to occur spontaneously, then they will be asked to imitate a specific tic when there is no urge to tic. Patients and healthy subjects will have electromyography (EMG) to record the timing of the voluntary movements and tics. For this procedure, several pairs of small, saucer-like electrodes are attached to the skin with a gel or paste. Electric signals from the electrodes are amplified and recorded on a computer. A microphone may be placed near patients to record any vocal tics. A video camera may also be used to record the tics.

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 Nov 2001

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

November 1, 2001

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2001

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2005

First QC Date

November 2, 2001

Last Update Submit

March 3, 2008

Conditions

Keywords

Voluntary MovementBasal GangliaFrontal LobeMotor CortexMotor Tic DisorderTourette's SyndromeVocal Tic DisorderTicHealthy VolunteerHVNormal Control

Eligibility Criteria

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

You may qualify if:

  • Patients will have a clinically documented tic disorder as defined by DSM-IV-TR and evaluation of tics severity using Yale Tic Sale. This criterion will be established by the preliminary screening in the NINDS Movement Disorders Outpatient Clinic.
  • Patients will be in age range 14 to 65.
  • Patients may be male or female.
  • Patients will be asked to stop any medications that can influence central nervous system for at least 24 hours prior to exam also they will be asked to abstain from alcohol for 24 hours before the study.
  • normal controls will be included; controls will be screened in the NINDS Movement Disorders Outpatient Clinic, and will have neurological and physical examination.
  • Controls with chronic illnesses, taking any medication that affects the CNS will be excluded.
  • Controls will be asked to abstain from alcohol for 24 hours before the study.
  • All subjects participating in MR studies should have a valid Clinical Center Medical Record Number.

You may not qualify if:

  • Patients younger than 14 years old will be excluded from the study.
  • Patients with MRI findings consistent with brain tumors, strokes, trauma or AVMs will be excluded.
  • Patients with progressive neurological disorders other than a tic disorder will be excluded.
  • Patients with a history of significant medical disorders, or requiring chronic treatment with other drugs, which cannot be stopped, will be excluded.
  • Patients with cancer will be excluded.
  • Pregnant women will be excluded.
  • Patients not capable of giving informed consent will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Karp BI, Porter S, Toro C, Hallett M. Simple motor tics may be preceded by a premotor potential. J Neurol Neurosurg Psychiatry. 1996 Jul;61(1):103-6. doi: 10.1136/jnnp.61.1.103.

    PMID: 8676135BACKGROUND
  • Makeig S, Jung TP, Bell AJ, Ghahremani D, Sejnowski TJ. Blind separation of auditory event-related brain responses into independent components. Proc Natl Acad Sci U S A. 1997 Sep 30;94(20):10979-84. doi: 10.1073/pnas.94.20.10979.

    PMID: 9380745BACKGROUND
  • Obeso JA, Rothwell JC, Marsden CD. Simple tics in Gilles de la Tourette's syndrome are not prefaced by a normal premovement EEG potential. J Neurol Neurosurg Psychiatry. 1981 Aug;44(8):735-8. doi: 10.1136/jnnp.44.8.735.

    PMID: 6946193BACKGROUND

MeSH Terms

Conditions

Tourette SyndromeTic DisordersTics

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 DisordersDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 2001

First Posted

November 5, 2001

Study Start

November 1, 2001

Study Completion

January 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-01

Locations