NCT00033995

Brief Summary

This study will investigate which areas of the brain are primarily involved in and responsible for tics in patients with Tourette's syndrome and chronic motor disorder. Tourette's syndrome is a neuropsychiatric disorder characterized by motor and vocal tics and is associated with behavioral and emotional disturbances, including symptoms of attention deficit hyperactivity disorder and obsessive-compulsive disorder. Chronic motor disorder has the same characteristics as Tourette's syndrome, except that patients do not have vocal tics. Healthy normal volunteers and patients with Tourette's syndrome or chronic motor tic disorder between 18 and 65 years of age may be eligible for this study. Candidates will be screened with a medical history and physical and neurological examinations. Participants will undergo positron emission tomography (PET) scanning to study tics under three conditions- spontaneous tics, suppression of tics, and sleep-to determine which areas of the brain are responsible for generation of tics. For this procedure, the subject is injected with H215O, a radioactive substance similar to water. A special camera detects the radiation emitted by the H215O, allowing measurement of brain blood flow. Subjects will receive up to 20 injections of H215O during the scanning. Participants will be asked not to sleep the entire night before the test. Before the scan, both patients and volunteers will have EEG electrodes placed on their heads to record the electrical activity of their brains. Patients will also have EMG electrodes placed in areas of the body where tics occur. A small catheter (plastic tube) will be placed in an arm vein for injecting the radioactive tracers, and a mask will be placed on the face to help keep the head still during scanning. The mask has large openings for eyes, nose and mouth, so that it does not interfere with talking or breathing. The entire test takes about 4 hours. During this time, the subject will sleep for 1.5 hours either at the beginning or end of the scan. For the other 2.5 hours, scans will be done every 10 minutes for 1 minute under the different conditions of tic suppression or release of tics. On a separate day, participants will also undergo magnetic resonance imaging (MRI), a diagnostic test that uses a magnetic field and radio waves to produce images of the brain. For this procedure, the subject lies still on a stretcher that is moved into the scanner (a narrow cylinder containing the magnet). ...

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 Apr 2002

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

April 17, 2002

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 18, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2002

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2009

Completed
Last Updated

July 2, 2017

Status Verified

February 17, 2009

First QC Date

April 18, 2002

Last Update Submit

June 30, 2017

Conditions

Keywords

TicsBasal GangliaNeuroimagingSleepSuppression of TicsTourette SyndromeTourette's SyndromeTic DisorderHealthy VolunteerHVNormal Control

Eligibility Criteria

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

You may qualify if:

  • Patients will have clinically documented Tourette's syndrome or chronic motor tic disorder as defined by DSM-IV-TR and evaluation of tic severity using the Yale Tic Scale. This criterion will be established by preliminary screening in the NINDS Movement Disorders Outpatient Clinic. Regarding co-morbid disorders such as ADHD and OCD, we will accept a mild degree of ADHD and mild to moderate degree of OCD. These disorders will be established by a psychiatrist using below listed scales and criteria. In order to participate in this study, patients will be asked to stop any medication that can influence the central nervous system for 2 weeks prior to exam. Patients taking fluoxetine will be asked to stop it 4 weeks prior to the exam. Stopping the medications for Tourette syndrome or tics, OCD and ADHD may lead to worsening of their symptoms.
  • Any changes to patients' medication must first be discussed with their doctor and only this doctor will be responsible for tapering the medication.
  • Patients will be asked to abstain from alcohol for one week before the study.
  • Patients will be in age ranges 18 to 65. Patients may be male or female. Female patients of child-bearing potential will have a pregnancy test and specific interview prior to the study to ensure that pregnant patients will not participate in the study. Patients will be asked to stop any medication that can influence central nervous system (CNS) for one week prior to exam.
  • Twenty three 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.

You may not qualify if:

  • Patients younger than 18 or older than 65 years old will be excluded from the study. We are excluding patients older than 65 years because of possibility of age-related neurological disorders such as stroke and dementia.
  • Patients with MRI findings consistent with brain tumors, strokes, trauma or AVMs will be excluded.
  • Patients with progressive neurological disorders other than TS or chronic motor tic disorder and significant other pathology 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.
  • Patients not capable of giving an informed consent will be excluded.
  • Patients who are pregnant will be excluded.

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)

  • Braun AR, Stoetter B, Randolph C, Hsiao JK, Vladar K, Gernert J, Carson RE, Herscovitch P, Chase TN. The functional neuroanatomy of Tourette's syndrome: an FDG-PET study. I. Regional changes in cerebral glucose metabolism differentiating patients and controls. Neuropsychopharmacology. 1993 Dec;9(4):277-91. doi: 10.1038/npp.1993.64.

    PMID: 8305128BACKGROUND
  • Brett PM, Curtis D, Robertson MM, Gurling HM. The genetic susceptibility to Gilles de la Tourette syndrome in a large multiple affected British kindred: linkage analysis excludes a role for the genes coding for dopamine D1, D2, D3, D4, D5 receptors, dopamine beta hydroxylase, tyrosinase, and tyrosine hydroxylase. Biol Psychiatry. 1995 Apr 15;37(8):533-40. doi: 10.1016/0006-3223(94)00161-U.

    PMID: 7619976BACKGROUND
  • Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.

    PMID: 2684084BACKGROUND

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

April 18, 2002

First Posted

April 19, 2002

Study Start

April 17, 2002

Study Completion

February 17, 2009

Last Updated

July 2, 2017

Record last verified: 2009-02-17

Locations