Investigating Epilepsy: Screening and Evaluation

NCT03478852 | Recruiting

• 2 other identifiers: 18006618-N-0066
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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. ...

Conditions

Partial Epilepsy; Seizures; Epilepsy; Epilepsy, Temporal Lobe

Keywords

Seizure Disorder; Seizures; Antiepileptic Drug; Natural History Study; Screening Protocol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Data obtained through clinical care will provide descriptive and/or correlative research

  5 year period

Study Arms (1)

Single Arm

Single arm open enrollment of patients with standard of care treatment and evaluation

Eligibility Criteria

• Age: 8 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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 assent (for minors 8 and older)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Seizures; Epilepsy; Epilepsy, Temporal Lobe; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Epileptic Syndromes

Study Officials

• Yasser Tajali, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaliyah M HamidullahThiam

CONTACT

(301) 402-7686; aaliyah.hamidullahthiam@nih.gov

Yasser Tajali, M.D.

CONTACT

(301) 594-9223; yasser.tajali@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 27, 2018
• Study Start: March 28, 2018
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03-16

Locations

US (1)