Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013845
Status:
TERMINATED
Last Update Posted:
2019-12-12
First Post:
2001-03-30
Brief Title:
Evaluation and Treatment of Patients With Epilepsy
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation and Treatment of Patients With Epilepsy
Status:
TERMINATED
Status Verified Date:
2018-06-26
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 protocol has three purposes 1 to screen patients with seizures for participation in research studies of NINDS s Clinical Epilepsy Section CES 2 to follow the natural course of seizure disorders and 3 to train CES fellows in evaluating and treating epilepsy Only standard diagnostic tests and treatments will be used in this study
Patients of any age with seizures who are referred to CES may participate in this study At the end of the study patients may be discharged to the care of their referring physician offered participation in another NINDS research protocol or followed for teaching purposes
Participants will undergo standard diagnostic procedures used to determine the type of their seizures what part of the brain they are coming from what is causing them and whether standard drug treatments can help them These may include some or all of the following
Physical and neurological examination
Neuropsychological tests tests of learning and memory
Electroencephalography EEG brain wave recording
Evoked potentials tests of nerve reactions to lights and sounds
Polysomnography simultaneous recordings of brain waves breathing and eye movements
Video-EEG monitoring simultaneous recording of seizures using a video camera and brain waves
Video-EEG monitoring with extra electrodes to record muscle activity breathing and eye movements for analyzing sleep patterns
Imaging studies such as magnetic resonance imaging MRI and positron emission tomography PET scans to examine the structure and function of the brain
Frequent blood tests to measure blood levels of anti-seizure drugs
Patients of any age with seizures who are referred to CES may participate in this study At the end of the study patients may be discharged to the care of their referring physician offered participation in another NINDS research protocol or followed for teaching purposes
Participants will undergo standard diagnostic procedures used to determine the type of their seizures what part of the brain they are coming from what is causing them and whether standard drug treatments can help them These may include some or all of the following
Physical and neurological examination
Neuropsychological tests tests of learning and memory
Electroencephalography EEG brain wave recording
Evoked potentials tests of nerve reactions to lights and sounds
Polysomnography simultaneous recordings of brain waves breathing and eye movements
Video-EEG monitoring simultaneous recording of seizures using a video camera and brain waves
Video-EEG monitoring with extra electrodes to record muscle activity breathing and eye movements for analyzing sleep patterns
Imaging studies such as magnetic resonance imaging MRI and positron emission tomography PET scans to examine the structure and function of the brain
Frequent blood tests to measure blood levels of anti-seizure drugs
Detailed Description:
Objectives To evaluate patients with epilepsy
Study Population adults and children with epilepsy
Design In this protocol we will use standard clinical studies including neurologic examination antiepileptic drug levels clinical neurophysiology EEG EMG evoked potentials simultaneous Video-EEG monitoring polysomnography computed tomography structural functional and spectroscopic magnetic resonance imaging and other studies such as FDG-PET performed by nuclear medicine as a clinical procedure and neuropsychological testing to evaluate patients referred for uncontrolled or suspected seizures Tests will be performed in patients when clinically indicated The protocol will be used to screen patients for inclusion in other protocols follow the natural history of seizure disorders and train fellows in the evaluation and treatment of epilepsy Both inpatients and outpatients will be studied Standard clinical evaluation and drug treatment of epilepsy is performed under this protocol
Outcome Measures clinical characteristics of epilepsy
Study Population adults and children with epilepsy
Design In this protocol we will use standard clinical studies including neurologic examination antiepileptic drug levels clinical neurophysiology EEG EMG evoked potentials simultaneous Video-EEG monitoring polysomnography computed tomography structural functional and spectroscopic magnetic resonance imaging and other studies such as FDG-PET performed by nuclear medicine as a clinical procedure and neuropsychological testing to evaluate patients referred for uncontrolled or suspected seizures Tests will be performed in patients when clinically indicated The protocol will be used to screen patients for inclusion in other protocols follow the natural history of seizure disorders and train fellows in the evaluation and treatment of epilepsy Both inpatients and outpatients will be studied Standard clinical evaluation and drug treatment of epilepsy is performed under this protocol
Outcome Measures clinical characteristics of epilepsy
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 |
|---|---|---|---|
| 01-N-0139 | None | None | None |