Clinical trial NCT03478852: Investigating Epilepsy: Screening and Evaluation
Official title: Investigating Epilepsy: Screening and Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Seizures
Epilepsy
Epilepsy, Temporal Lobe
Partial Epilepsy
Keywords: Seizure Disorder
Seizures
Antiepileptic Drug
Natural History Study
Screening Protocol
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2018-03-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 8
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and Children age 8 years and older referred with a known or suspected diagnosis of epilepsy

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.

Eligibility 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 assent (for minors 8 and older)

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

Primary outcomes:
measure: Screening and characterization of patients with drug-resistant epilepsy for epilepsy-related protocols
timeFrame: 5 year period
Secondary outcomes:
measure: Data obtained through clinical care will provide descriptive and/or correlative research
timeFrame: 5 year period
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
name: Yasser Tajali, M.D.
role: PRINCIPAL_INVESTIGATOR
References: