NCT00013845

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,278

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2001

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2001

Completed
17.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2018

Completed
Last Updated

December 12, 2019

Status Verified

June 26, 2018

First QC Date

March 30, 2001

Last Update Submit

December 11, 2019

Conditions

Keywords

SeizuresAnti-Epileptic DrugsPharmacotherapyNeuropsychologyTemporal Lobe EpilepsyFrontal Lobe EpilepsyComplex Partial SeizuresGrand Mal SeizuresGeneralized SeizuresEpilepsy

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 9092951BACKGROUND
  • 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.

    PMID: 10714408BACKGROUND
  • 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.

    PMID: 8681908BACKGROUND

MeSH Terms

Conditions

EpilepsySeizuresEpilepsy, Temporal LobeEpilepsy, Frontal LobeEpilepsy, Tonic-Clonic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEpilepsies, PartialEpileptic SyndromesEpilepsy, Generalized

Study Officials

  • Sara K Inati, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2001

First Posted

April 2, 2001

Study Start

May 1, 2001

Study Completion

June 26, 2018

Last Updated

December 12, 2019

Record last verified: 2018-06-26

Locations