Evaluation and Treatment of Patients With Epilepsy
2 other identifiers
observational
1,278
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2001
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2001
CompletedFirst Posted
Study publicly available on registry
April 2, 2001
CompletedStudy Start
First participant enrolled
May 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2018
CompletedDecember 12, 2019
June 26, 2018
March 30, 2001
December 11, 2019
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- All patients older than 2 years referred to the Clinical Epilepsy Section will be included. DPA assignment for adults without consent capacity is required at the time of enrollment.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Baker GA, Nashef L, van Hout BA. Current issues in the management of epilepsy: the impact of frequent seizures on cost of illness, quality of life, and mortality. Epilepsia. 1997;38 Suppl 1:S1-8. doi: 10.1111/j.1528-1157.1997.tb04511.x.
PMID: 9092951BACKGROUNDBegley 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. doi: 10.1111/j.1528-1157.2000.tb00166.x.
PMID: 10714408BACKGROUNDHanai T. Quality of life in children with epilepsy. Epilepsia. 1996;37 Suppl 3:28-32. doi: 10.1111/j.1528-1157.1996.tb01816.x.
PMID: 8681908BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara K Inati, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2001
First Posted
April 2, 2001
Study Start
May 1, 2001
Study Completion
June 26, 2018
Last Updated
December 12, 2019
Record last verified: 2018-06-26