Evaluation and Treatment of Patients With Epilepsy

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Overall Status

Terminated

CT.gov ID

NCT00013845

Collaborator

(none)

1,278

Enrollment

Location

205.8

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Epilepsy

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

Study Design

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 :

Jun 26, 2018

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.