Official Title: “Evaluation and Treatment of Patients With Epilepsy”
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
- Study Type: Observational
- Study Design: N/A
Detailed Clinical Trial 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
Criteria for Participation in this Clinical Trial
All patients older than 2 years referred to the Clinical Epilepsy Section will be included.
REMOTELY MONITORED SUBGROUP:
1. Those enrolled in the remotely monitored subgroup must use one of the available standardized seizure diary tools.
2. Those enrolled in the remotely monitored subgroup must be comfortable enough with written English to use one of the available standardized seizure diary tools. (The protocol will be amended if other language tools become available)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 2 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial: No
Clinical Trial Investigator Information
- Lead Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Provider of Information About this Clinical Study
- Overall Official(s)
- William H Theodore, M.D., Principal Investigator, National Institute of Neurological Disorders and Stroke (NINDS)
- Overall Contact(s)
- Tamika Mason, (301) 496-1923, firstname.lastname@example.org
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Begley CE, Famulari M, Annegers JF, Lairson DR, Reynolds TF, Coan S, Dubinsky S, Newmark ME, Leibson C, So EL, Rocca WA. The cost of epilepsy in the United States: an estimate from population-based clinical and survey data. Epilepsia. 2000 Mar;41(3):342-51.
Hanai T. Quality of life in children with epilepsy. Epilepsia. 1996;37 Suppl 3:28-32.