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Investigating Epilepsy: Screening, Evaluation and Treatment

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ClinicalTrials.gov Identifier: NCT03478852
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : June 12, 2019
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:

Objectives:

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.

Study Population:

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

Design:

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.

Outcome Measures:

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
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 : August 31, 2027


Group/Cohort
1
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: Ongoing ]
    Patients will be screened for eligibility for epilepsy-related research protocols.


Secondary Outcome Measures :
  1. Teaching and training of clinical fellows and residents [ Time Frame: Ongoing ]
  2. Provision of standard care evaluation and medical management of enrolled patients [ Time Frame: Ongoing ]


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 or adults without consent capacity)

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) 496-5121 aaliyah.hamidullahthiam@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     History of Changes
Other Study ID Numbers: 180066
18-N-0066
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 10, 2019

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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
Signs and Symptoms
Epileptic Syndromes