Investigating Epilepsy: Screening and Evaluation

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Yasser Tajali, M.D.; Phone Number: (301) 594-9223; Email: yasser.tajali@nih.gov
• Study Contact Backup: Name: Aaliyah M HamidullahThiam; Phone Number: (301) 402-7686; Email: aaliyah.hamidullahthiam@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY8664111010 800-411-1222; Email: prpl@cc.nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults and Children age 8 years and older referred with a known or suspected diagnosis of epilepsy

Description

• INCLUSION CRITERIA:
• Age 8 years or older
• Known or suspected diagnosis of epilepsy
• Ability to give informed consent or have a legally authorized representative able to give consent (for adults without consent capacity) or parent/guardian able to provide informed consent (for a child)
• If unable to give informed consent, ability to give verbal assent

EXCLUSION CRITERIA:

• Patients with unstable medical conditions that, in the opinion of the investigators, makes participation unsafe, or who, in the opinion of the investigators may be unable to comply with the protocol
• Patients who are unable to travel to the NIH

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single Arm; Single arm open enrollment of patients with standard of care treatment and evaluation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Yasser Tajali, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 24, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 26, 2026

More Information

Terms related to this study

• Keywords: Natural History Study; Seizures; Seizure Disorder; Antiepileptic Drug; Screening Protocol
• Additional Relevant MeSH Terms: Epileptic Syndromes; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Epilepsy; Seizures; Epilepsies, Partial; Epilepsy, Temporal Lobe
• Other Study ID Numbers: 180066; 18-N-0066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No