Surgery as a Treatment for Medically Intractable Epilepsy
|First Received Date ICMJE||January 7, 2011|
|Last Updated Date||June 16, 2015|
|Start Date ICMJE||December 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Change in seizure frequency [ Time Frame: 1 year ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01273129 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Surgery as a Treatment for Medically Intractable Epilepsy|
|Official Title ICMJE||Surgery as a Treatment for Medically Intractable Epilepsy|
- 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.
- To use surgery as a treatment for medically intractable epilepsy in children and adults.
- 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.
This protocol is being performed to study the normal human biology and disease pathogenesis (natural history) in patients with medically intractable epilepsy, 2) provide standard surgical treatment of medically intractable epilepsy, 3) follow the course of patients after epilepsy surgery, and 4) to investigate neurophysiological correlates of human cognitive processes such as memory, learning, attention, language, perception, and action. Neurophysiologic recordings will be compared with those in the resting awake state and during sleep.. Any treatment under this protocol will be based on the current standard of care for epilepsy surgery.
Patients 8 years and older whose seizures are uncontrollable with medication may participate in this study.
Patients will be screened by study neurologists to confirm their diagnosis of medically intractable epilepsy. Patients that do not have a confirmed diagnosis of medically intractable epilepsy will be offered further evaluation in protocol 01-N-0139, Evaluation and Treatment of Patients with Epilepsy. Patients confirmed to have medically intractable 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.
Patients 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.
The primary outcome measure 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; 5) incidence of serious complications of epileptic seizures, and 6) neurophysiological correlates of cognitive function.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||100|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
To be eligible for entry into the study, candidates must meet all the following criteria:
Candidates will be excluded if they:
|Ages||8 Years and older|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01273129|
|Other Study ID Numbers ICMJE||110051, 11-N-0051|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP