Surgery as a Treatment for Medically Intractable Epilepsy
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 8 - 100 |
| Updated: | 2/6/2019 |
| Start Date: | December 7, 2010 |
| Contact: | Aaliyah H Thiam |
| Email: | SNBrecruiting@nih.gov |
| Phone: | Not Listed |
Background:
- Medically intractable 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 training more
neurologists and neurosurgeons in epilepsy surgery and care in order to better understand
epilepsy and its treatment.
Objectives:
- To use surgery as a treatment for medically intractable 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.
- Wada test to evaluate speech, comprehension, and memory centers of the brain, using a
contrast dye to study the blood vessels of the brain and a short-term anesthetic
administration procedure to test the effects on areas of speech and memory.
- Depth electrodes and/or brain surface electrodes 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.
- Medically intractable 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 training more
neurologists and neurosurgeons in epilepsy surgery and care in order to better understand
epilepsy and its treatment.
Objectives:
- To use surgery as a treatment for medically intractable 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.
- Wada test to evaluate speech, comprehension, and memory centers of the brain, using a
contrast dye to study the blood vessels of the brain and a short-term anesthetic
administration procedure to test the effects on areas of speech and memory.
- Depth electrodes and/or brain surface electrodes 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.
Objective
This protocol is being performed provide standard care therapy for patients with drug
resistant epilepsy and to follow the therapeutic course of patients from pre-operative
evaluation, through surgery, and post-operatively, and to collect prospective data on seizure
outcomes following surgery to add to the body of knowledge in this field. Primary outcome
measures will be used to assess efficacy of
surgery for clinical care purposes. Any treatment under this protocol will be based on the
current standard of care for epilepsy surgery. The secondary goals of this protocol will be
to investigate neurophysiological correlates of human cognitive function and to provide
invasive monitoring for patients with tumor related epilepsy.
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, and 5)
multiple subpial transection.
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 two years after the surgical
procedure and will receive standard neurological examinations and MRI evaluation of the
brain. Patients who do not have surgical resection of epileptogenic tissue will complete
participation after the three-month post-op visit. 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 seperate protocol, 16-N-0041 Tumor Related
Epilepsy. Patients will complete participation after the three-month post-op visit.
Outcome Measures
The primary goal of this protocol is to provide standard care therapy for patients with drug
resistant epilepsy, and to determine the efficacy of surgery for treatment while collecting
physiology, tissue, and behavioral data for research.The primary outcome measure for patients
with drug resistant epilepsy is the change in seizure frequency, as measured by the Engel
scale before and 1 year after treatment. Secondary outcome measures include 1) percentage of
patients who are able to be completely withdrawn from anti-epileptic medication; 2)
percentage of patients who are seizure-free (Engel Class I); 3) mean Engel Class one year
after surgery stratified by the type of surgical procedure; 4) percentage of patients with
permanent neurological side-effects from surgical treatment; and 5) neurophysiological
correlates of cognitive function. Outcomes for patients with tumor related epilepsy will be
assessed under a seperate protocol, 16-N-0041, Tumor Related Epilepsy.
This protocol is being performed provide standard care therapy for patients with drug
resistant epilepsy and to follow the therapeutic course of patients from pre-operative
evaluation, through surgery, and post-operatively, and to collect prospective data on seizure
outcomes following surgery to add to the body of knowledge in this field. Primary outcome
measures will be used to assess efficacy of
surgery for clinical care purposes. Any treatment under this protocol will be based on the
current standard of care for epilepsy surgery. The secondary goals of this protocol will be
to investigate neurophysiological correlates of human cognitive function and to provide
invasive monitoring for patients with tumor related epilepsy.
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, and 5)
multiple subpial transection.
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 two years after the surgical
procedure and will receive standard neurological examinations and MRI evaluation of the
brain. Patients who do not have surgical resection of epileptogenic tissue will complete
participation after the three-month post-op visit. 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 seperate protocol, 16-N-0041 Tumor Related
Epilepsy. Patients will complete participation after the three-month post-op visit.
Outcome Measures
The primary goal of this protocol is to provide standard care therapy for patients with drug
resistant epilepsy, and to determine the efficacy of surgery for treatment while collecting
physiology, tissue, and behavioral data for research.The primary outcome measure for patients
with drug resistant epilepsy is the change in seizure frequency, as measured by the Engel
scale before and 1 year after treatment. Secondary outcome measures include 1) percentage of
patients who are able to be completely withdrawn from anti-epileptic medication; 2)
percentage of patients who are seizure-free (Engel Class I); 3) mean Engel Class one year
after surgery stratified by the type of surgical procedure; 4) percentage of patients with
permanent neurological side-effects from surgical treatment; and 5) neurophysiological
correlates of cognitive function. Outcomes for patients with tumor related epilepsy will be
assessed under a seperate protocol, 16-N-0041, Tumor Related Epilepsy.
- INCLUSION CRITERIA:
To be eligible for entry into the study, candidates must meet all the following criteria:
1. Be 8 years of age or older with drug resistant epilepsy or tumor related epilepsy.
2. Have focal onset seizures.
3. Seizures must persist despite medical therapy (drug resistant epilepsy) or seizures
must be associated with the presence of a brain tumor.
4. Able to give informed consent, or have a parent able to provide informed consent if a
child.
5. Agree to undergo brain surgery if indicated to treat drug resistant epilepsy.
EXCLUSION CRITERIA:
Candidates will be excluded if they:
1. Are pregnant (subjects of childbearing age will be tested with a urine pregnancy test
and will have agreed to avoid being pregnant by practicing a reliable form of
contraception or by abstinence from sexual intercourse while undergoing evaluation for
epilepsy surgery and for 1 month after epilepsy surgery).
2. Cannot have an MRI scan.
3. Have a bleeding disorder that cannot be corrected before invasive testing or surgery,
or other medical conditions which would make testing or surgery unsafe, such as lung
or cardiac disease which would increase the risk of general anesthesia or severe
immunodeficiency or systemic cancer not related to a brain lesion.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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