Evaluation and Treatment of Patients With Epilepsy
Primary Purpose
Epilepsy
Status
Terminated
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Epilepsy focused on measuring Seizures, Anti-Epileptic Drugs, Pharmacotherapy, Neuropsychology, Temporal Lobe Epilepsy, Frontal Lobe Epilepsy, Complex Partial Seizures, Grand Mal Seizures, Generalized Seizures, Epilepsy
Eligibility Criteria
INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: None.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00013845
First Posted
March 30, 2001
Last Updated
December 11, 2019
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00013845
Brief Title
Evaluation and Treatment of Patients With Epilepsy
Official Title
Evaluation and Treatment of Patients With Epilepsy
Study Type
Observational
2. Study Status
Record Verification Date
June 26, 2018
Overall Recruitment Status
Terminated
Study Start Date
May 1, 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 26, 2018 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Seizures, Anti-Epileptic Drugs, Pharmacotherapy, Neuropsychology, Temporal Lobe Epilepsy, Frontal Lobe Epilepsy, Complex Partial Seizures, Grand Mal Seizures, Generalized Seizures, Epilepsy
7. Study Design
Enrollment
1278 (Actual)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
None.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara K Inati, M.D.
Organizational Affiliation
National Institute of Neurological Disorders and Stroke (NINDS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9092951
Citation
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.
Results Reference
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PubMed Identifier
10714408
Citation
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. doi: 10.1111/j.1528-1157.2000.tb00166.x.
Results Reference
background
PubMed Identifier
8681908
Citation
Hanai T. Quality of life in children with epilepsy. Epilepsia. 1996;37 Suppl 3:28-32. doi: 10.1111/j.1528-1157.1996.tb01816.x.
Results Reference
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Evaluation and Treatment of Patients With Epilepsy
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