Evaluation and Treatment of Patients With Epilepsy
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Purpose
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
| Condition |
|---|
|
Epilepsy |
| Study Type: | Observational |
| Official Title: | Evaluation and Treatment of Patients With Epilepsy |
| Estimated Enrollment: | 1500 |
| Study Start Date: | March 2001 |
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
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
All patients older than 2 years referred to the Clinical Epilepsy Section will be included for outpatient screening.
EXCLUSION CRITERIA:
None.
Contacts and Locations| Contact: Patricia M Reeves-Tyer, R. EEG T. | (301) 496-1923 | tyerp@ninds.nih.gov |
| Contact: William H Theodore, M.D. | (301) 496-1505 | theodorw@ninds.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | William H Theodore, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00013845 History of Changes |
| Other Study ID Numbers: | 010139, 01-N-0139 |
| Study First Received: | March 30, 2001 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Seizures Anti-Epileptic Drugs Pharmacotherapy Neuropsychology Temporal Lobe Epilepsy |
Frontal Lobe Epilepsy Complex Partial Seizures Grand Mal Seizures Generalized Seizures Epilepsy |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013