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Investigating Epilepsy: Screening and Evaluation

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 : July 14, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

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.


Condition or disease
Seizures Epilepsy 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Epilepsy: Screening and Evaluation
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : July 30, 2027
Estimated Study Completion Date : July 30, 2027


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



Primary Outcome Measures :
  1. Screening and characterization of patients with drug-resistant epilepsy for epilepsy-related protocols [ Time Frame: 5 year period ]
    to characterization of patients epilepsy to determine their eligibility for inclusion in other epilepsy-related protocols.


Secondary Outcome Measures :
  1. Data obtained through clinical care will provide descriptive and/or correlative research [ Time Frame: 5 year period ]
    data obtained through clinical care provided under this protocol in descriptive and/or correlative research in this and other protocols.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

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


Contacts
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Contact: Aaliyah H Hamidullah-Thiam (301) 402-7686 aaliyah.hamidullahthiam@nih.gov
Contact: Sara K Inati, M.D. (301) 435-6269 inatisk@mail.nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Sara K Inati, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT03478852    
Other Study ID Numbers: 180066
18-N-0066
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 12, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Seizure Disorder
Seizures
Antiepileptic Drug
Natural History Study
Screening Protocol
Additional relevant MeSH terms:
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Epilepsy
Seizures
Epilepsies, Partial
Epilepsy, Temporal Lobe
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Epileptic Syndromes