Investigating Epilepsy: Screening, Evaluation and Treatment
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Neurology, Epilepsy, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 8 - Any |
| Updated: | 3/22/2019 |
| Start Date: | March 28, 2018 |
| End Date: | August 31, 2027 |
| Contact: | Aaliyah H Thiam |
| Email: | aaliyah.hamidullahthiam@nih.gov |
| Phone: | (301) 496-5121 |
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.
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.
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.
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.
- 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
Click here to add this to my saved trials
