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Trial record 1 of 3 for:    01-N-0139
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Evaluation and Treatment of Patients With Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00013845
Recruitment Status : Terminated
First Posted : April 2, 2001
Last Update Posted : December 12, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

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

Condition or disease

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

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Study Type : Observational
Actual Enrollment : 1278 participants
Official Title: Evaluation and Treatment of Patients With Epilepsy
Study Start Date : May 1, 2001
Study Completion Date : June 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.



Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00013845

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Sara K Inati, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS) Identifier: NCT00013845    
Other Study ID Numbers: 010139
First Posted: April 2, 2001    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: June 26, 2018
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Anti-Epileptic Drugs
Temporal Lobe Epilepsy
Frontal Lobe Epilepsy
Complex Partial Seizures
Grand Mal Seizures
Generalized Seizures
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases