Investigating Epilepsy: Screening and Evaluation

Recruiting

• Conditions: Seizures; Epilepsy, Temporal Lobe; Partial Epilepsy; Epilepsy

• Registration Number: NCT03478852
• Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Brief Summary

Background:

Epilepsy affects about 1 percent of the U.S. population. Most people with epilepsy respond well to medicine, but some do not. Researchers want people who have diagnosed or suspected epilepsy to participate in ongoing studies. They want to learn more about clinical care for epilepsy. They want fellows and residents to learn more about the care of people with epilepsy.

Objectives:

To learn more about seizures and find ways to best treat people with drug-resistant epilepsy.

Eligibility:

Adults and children ages 8 years and older with diagnosed or suspected epilepsy

Design:

Participants will be screened with:

Physical exam

Medical history

Questionnaires

Participants will have many visits. They may be admitted to the hospital for several weeks. Their medication might be stopped or changed.

Participants will have many tests:

Blood and urine tests

EEG: Wires attached to the head with paste record brain waves. This may be videotaped.

Thinking and memory tests

MRI: Participants lie on a table that slides in and out of a tube. They perform simple tasks in the tube.

MEG: Participants lie on a table and place their head in a helmet to record brain waves.

PET scan: Participants lie on a table that slides into a machine. A small amount of radioactive dye is injected into their arm with an IV. For the IV, a small tube is inserted into the arm with a needle.

Participants will stay enrolled in this study if they join other epilepsy-related studies. They may be contacted at intervals for follow-up. Their participation will end if they have not been seen clinically for their epilepsy for 3 years.

Detailed Description

Study Description:\<TAB\>

This protocol is designed to serve as a screening protocol that provides standard evaluation and treatment for patients with epilepsy. Clinical data collected through this protocol will be used in other NIH epilepsy-related research to screen for eligibility in the respective protocols and may also be used for descriptive and/or correlative research through this protocol.

Objectives:

Primary Objective:

Maintain a cohort of patients who are referred to the NIH with a known or suspected diagnosis of epilepsy that can be accessed by other NIH studies to screen for eligibility to participate in ongoing epilepsy-related protocols.

Secondary Objectives:

* to follow the natural history of subjects with epilepsy and epilepsy and related disorders, and

* to allow for descriptive and/or correlational studies based on the data collected through clinical care of these patients.

Study Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-24
• Study First Posted: 2018-03-27
• Study Start: 2018-03-28
• Status Verified: 2025-05-08
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-25
• Primary Completion: 2027-07-30
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Screening and characterization of patients with drug-resistant epilepsy for epilepsy-related protocols	5 year period	to characterization of patients epilepsy to determine their eligibility for inclusion in other epilepsy-related protocols.

Secondary Outcome Measures

Name	Time	Method
Data obtained through clinical care will provide descriptive and/or correlative research	5 year period	data obtained through clinical care provided under this protocol in descriptive and/or correlative research in this and other protocols.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States