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Evaluation and Treatment of Patients With Epilepsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 23, 2017 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ) Identifier:
First received: March 30, 2001
Last updated: April 20, 2017
Last verified: March 23, 2017

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
Official Title: Evaluation and Treatment of Patients With Epilepsy

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 21500
Study Start Date: March 28, 2001
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


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

All patients older than 2 years referred to the Clinical Epilepsy Section will be included.


  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)


  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00013845

Contact: Tamika Mason (301) 496-1923
Contact: William H Theodore, M.D. (301) 496-1505

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   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: William H Theodore, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS) Identifier: NCT00013845     History of Changes
Other Study ID Numbers: 010139
Study First Received: March 30, 2001
Last Updated: April 20, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Anti-Epileptic Drugs
Temporal Lobe Epilepsy
Frontal Lobe Epilepsy
Complex Partial Seizures
Grand Mal Seizures
Generalized Seizures

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on May 23, 2017