Clinical Trial: Surgery as a Treatment for Medically Intractable Epilepsy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Surgery as a Treatment for Medically Intractable Epilepsy

Brief Summary:

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

    Detailed Summary:

    Objective

    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, 4) to investigate neurophysiological correlates of human cognitive processes such as memory, learning, attention, language, perception, and action, and 5) to provide invasive monitoring to patients with tumor related epilepsy. 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.

    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 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
    Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

    Current Primary Outcome: Change in seizure frequency [ Time Frame: 1 year ]

    Original Primary Outcome:

    Current Secondary Outcome:

    • Percentage seizure-free [ Time Frame: 1 year ]
    • Mean Engel Class one year after surgery [ Time Frame: 1 year ]
    • Percentage with permanent neurological side-effects from surgical treatment [ Time Frame: 1 year ]
    • Incidence of serious complications of epileptic seizures [ Time Frame: 1 year ]
    • Percentage of patients who are able to be completely withdrawn from anti-epileptic medication; [ Time Frame: 1 years ]


    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: January 7, 2011
    Date Started: December 7, 2010
    Date Completion:
    Last Updated: April 26, 2017
    Last Verified: April 17, 2017