- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00026000
Brain Activation in Vocal and Motor Tics
Brain Activation in Motor and Vocal Tics in Patients With Tourette's Syndrome or Chronic Motor or Vocal Tic Disorder Using Blood Oxygenation Level Dependent Functional MRI
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA
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.
10 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.
EXCLUSION CRITERIA
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.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Syndrome
- Disease
- Tourette Syndrome
- Tic Disorders
- Tics
Other Study ID Numbers
- 020027
- 02-N-0027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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