Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01273129 |
| Other study ID # |
110051 |
| Secondary ID |
11-N-0051 |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 21, 2011 |
Study information
| Verified date |
May 23, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
Gretchen C Scott, R.N. |
| Phone |
Not Listed |
| Email |
SNBrecruiting[@]nih.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background:
- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by
medication. Many people whose seizures do not respond to medication will respond to surgical
treatment, relieving seizures completely or almost completely in one-half to two-thirds of
patients who qualify for surgery. The tests and surgery performed as part of this treatment
are not experimental, but researchers are interested in using the data collected as part of
routine standard epilepsy care to better understand epilepsy and its treatment.
Objectives:
- To use surgery as a treatment for drug resistant epilepsy in children and adults.
Eligibility:
- Children and adults at least 8 years of age who have simple or complex partial seizures
(seizures that come from one area of the brain) that have not responded to medication, and
who are willing to have brain surgery to treat their medically intractable epilepsy.
Design:
- Participants will be screened with a medical history, physical examination, and
neurological examination. Imaging studies, including magnetic resonance imaging and
computer-assisted tomography (CT), may also be conducted as part of the screening.
Participants who do not need surgery or whose epilepsy cannot be treated surgically will
follow up with a primary care physician or neurologist and will not need to return to
the National Institutes of Health for this study.
- Prior to the surgery, participants will have the following procedures to provide
information on the correct surgical approach.
- Video electroencephalography monitoring to measure brain activity during normal
activities within a 24-hour period. Three to four 15-minute breaks are allowed within
this period.
- Electrodes placed directly in the brain or on the surface of the brain to measure brain
activities and determine the part of the brain that is responsible for the seizures
(seizure focus).
- Participants will have a surgical procedure at the site of their seizure focus. Brain
lesions, abnormal blood vessels, tumors, infections, or other areas of brain abnormality
will be either removed or treated in a way that will stop or help prevent the spread of
seizures without affecting irreplaceable brain functions, such as the ability to speak,
understand, move, feel, or see.
- Participants will return for outpatient visits and brain imaging studies 2 months, 1
year, and 2 years after surgery.
Description:
Objective
This protocol is being performed to collect prospective data on patients who receive standard
of care treatment for drug resistant epilepsy and to follow the natural history of patients
receiving epilepsy surgery, to investigate neurophysiological correlates of human cognitive
function, to provide invasive monitoring for patients with tumor related epilepsy. Any
treatment under this protocol will be based on the current standard of care for epilepsy
surgery.
Study Population
Patients 8 years and older whose seizures are uncontrollable with medication may participate
in this study as well as patients with tumor related epilepsy in whom invasive monitoring is
indicated.
Study Design
Patients will be screened by study neurologists to confirm their diagnosis of drug resistant
epilepsy. Patients that do not have a confirmed diagnosis of drug resistant epilepsy will be
offered further evaluation in protocol 18-N-0066, Investigating Epilepsy: Screening,
Evaluation and Treatment. Patients confirmed to have drug resistant epilepsy will be offered
standard invasive and non-invasive diagnostic and surgical procedures. Diagnostic invasive
monitoring with intracranial electrodes for further localization of their seizure focus may
be required. The ultimate goal is to surgically remove or modify the epileptic focus.
Standard procedures to be performed are 1) anterior temporal lobectomy or 2)
amygdalohippocampectomy for temporal lobe epilepsy, 3) focal cortical resection for epilepsy
that arises outside the temporal lobe, 4) removal of brain lesions causing epilepsy, 5)
multiple subpial transection, and 6) placement of neurostimulator devices. These procedures
are all FDA approved standard of care for treatment of drug resistant epilepsy.
In patients in whom invasive monitoring is medically necessary, neurophysiologic activity
during cognitive tasks will be captured from intracranial surface and depth electrodes.
Analysis will focus on the role of neuronal firing and aggregate neural activity 1) during
cognitive function, 2) in other states such as wakefulness and sleep, and 3) during periods
of time surrounding seizure activity.
Drug Resistant Epilepsy
Patients with drug resistant epilepsy will be followed for three months after the surgical
procedure and will receive standard neurological examinations and MRI evaluation of the
brain. Participants in this protocol will be evaluated for potential eligibility for other
NINDS clinical trials.
Tumor Related epilepsy
Patients with tumor related epilepsy will be enrolled in this protocol because of clinical
indications arising from participation in a separate protocol, 16-N-0041 Tumor Related
Epilepsy. Patients will complete participation after the three-month post-op visit.
Outcome Measures
By providing standard care treatment for patients with drug resistant epilepsy, this protocol
allows for descriptive and/or correlational studies based on the data collected through
clinical care of these patients including neurophysiological correlates of cognitive function
and studies of tissue sample acquired during surgery. Outcomes for patients with tumor
related epilepsy will be assessed under a separate protocol, 16-N-0041, Tumor Related
Epilepsy.
