Investigating Epilepsy: Screening, Evaluation and Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03478852|
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : February 26, 2020
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.
To learn more about seizures and find ways to best treat people with drug-resistant epilepsy.
Adults and children ages 8 years and older with diagnosed or suspected epilepsy
Participants will be screened with:
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.
|Condition or disease|
|Seizures Epilepsy Epilepsy, Temporal Lobe Partial Epilepsy|
The primary objective is to screen patients who are referred to the NIH with a known or suspected diagnosis of epilepsy for eligibility to participate in ongoing epilepsy-related protocols. The secondary objectives are to provide standard of care evaluation and treatment of patients with drug-resistant epilepsy, to provide training for clinical fellows in the evaluation and treatment of epilepsy and related disorders, and to allow for descriptive and/or correlational studies based on the data collected through clinical care of these patients.
Adults and children age 8 years and older referred with a known or suspected diagnosis of epilepsy.
Participants in this protocol will be evaluated by study investigators with standard diagnostic clinical studies as clinically indicated to fully characterize their seizures and related clinical features. Testing may include history and neurologic examination, blood tests including antiepileptic drug levels, clinical neurophysiology testing, structural and functional magnetic resonance imaging, magnetoencephalography, FDG-PET (performed by nuclear medicine as a clinical procedure), and neuropsychological testing. Patients may be evaluated in an outpatient or inpatient setting or both as clinically indicated. Clinical medical management of epilepsy will be performed under this protocol. Follow up will be performed as clinically indicated.
Patients will be screened for eligibility for epilepsy-related research protocols. In addition, patients with epilepsy will be evaluated and treated, clinical fellows will obtain training in the care of patients with epilepsy, and samples and/or data obtained through clinical care will be used for descriptive and/or correlative research.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Investigating Epilepsy: Screening, Evaluation and Treatment|
|Actual Study Start Date :||March 28, 2018|
|Estimated Primary Completion Date :||July 30, 2027|
|Estimated Study Completion Date :||July 30, 2027|
Single arm open enrollment of patients with standard of care treatment and evaluation
- Screening and characterization of patients with drug-resistant epilepsy for epilepsy-related protocols [ Time Frame: Ongoing ]Patients will be screened for eligibility for epilepsy-related research protocols.
- Teaching and training of clinical fellows and residents [ Time Frame: Ongoing ]
- Provision of standard care evaluation and medical management of enrolled patients [ Time Frame: Ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478852
|Contact: Aaliyah H Hamidullah-Thiam||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Sara K Inati, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|