Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033995
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2002-04-18
Brief Title:
Study of Tics in Patients With Tourettes Syndrome and Chronic Motor Tic Disorder
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Study of Tics in Patients With Tourettes Syndrome and Chronic Motor Tic Disorder With 15OH2O PET in Awake and in Sleep States
Status:
COMPLETED
Status Verified Date:
2009-02-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate which areas of the brain are primarily involved in and responsible for tics in patients with Tourettes syndrome and chronic motor disorder Tourettes 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 Tourettes syndrome except that patients do not have vocal tics
Healthy normal volunteers and patients with Tourettes 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 15 hours either at the beginning or end of the scan For the other 25 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
Healthy normal volunteers and patients with Tourettes 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 15 hours either at the beginning or end of the scan For the other 25 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
Detailed Description:
The purpose of this study is to determine the areas of the brain responsible for tics in patients with Tourettes syndrome and chronic motor tic disorder using 15OH2O Previous neuroimaging studies have looked at brain activity during tics using functional magnetic resonance imaging fMRI and positron emission tomography PET but a major drawback of these studies lay in the difficulty distinguishing between the activity in the brain responsible for tic generation versus activity in motor-related structures due to tic movements We plan to overcome this difficulty in our paradigm using two rest conditions without any movement One is a state when patients suppress their tics and the second is sleep state when tics usually cease or are at least very infrequent 23 adult patients with a DSM-IV-TR American Psychiatric Association 2000 diagnosis of a tic disorder and frequent tics will be studied These two rest states will be compared with a condition where tics are allowed to occur spontaneously The differential activation of brain areas between these three conditions should help to elucidatedefine the regions of the brain responsible for generation of tics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-N-0175 | None | None | None |