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Investigating Epilepsy: Screening and Evaluation

Investigating Epilepsy: Screening and Evaluation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03478852
Enrollment
1000
Registered
2018-03-27
Start date
2018-03-28
Completion date
2027-07-30
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Epilepsy, Temporal Lobe, Partial Epilepsy, Seizures

Keywords

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

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.

Interventions

None listed

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 110 Years
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Screening and characterization of patients with drug-resistant epilepsy for epilepsy-related protocols5 year periodto characterization of patients epilepsy to determine their eligibility for inclusion in other epilepsy-related protocols.

Secondary

MeasureTime frameDescription
Data obtained through clinical care will provide descriptive and/or correlative research5 year perioddata obtained through clinical care provided under this protocol in descriptive and/or correlative research in this and other protocols.

Countries

United States

Contacts

CONTACTAaliyah M HamidullahThiam
aaliyah.hamidullahthiam@nih.gov(301) 402-7686
CONTACTYasser Tajali, M.D.
yasser.tajali@nih.gov(301) 594-9223
PRINCIPAL_INVESTIGATORYasser Tajali, M.D.

National Institute of Neurological Disorders and Stroke (NINDS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026