Evaluation and Treatment of Patients With Epilepsy

• ClinicalTrials.gov Identifier: NCT00013845
• Recruitment Status: Terminated
• First Posted: April 2, 2001
• Last Update Posted: December 12, 2019
• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

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
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: June 26, 2018

Groups and Cohorts

Outcome Measures

Eligibility Criteria

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

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.

Contacts and Locations

Locations

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)

Investigators

• Principal Investigator: Sara K Inati, M.D.; National Institute of Neurological Disorders and Stroke (NINDS)

More Information

Publications:

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. Review.

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.

Hanai T. Quality of life in children with epilepsy. Epilepsia. 1996;37 Suppl 3:28-32.

• Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
• ClinicalTrials.gov Identifier: NCT00013845
• Other Study ID Numbers: 010139; 01-N-0139
• First Posted: April 2, 2001
• 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) ):

Seizures; Anti-Epileptic Drugs; Pharmacotherapy; Neuropsychology; Temporal Lobe Epilepsy; Frontal Lobe Epilepsy; Complex Partial Seizures; Grand Mal Seizures; Generalized Seizures; Epilepsy

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases