Epilepsy Clinical Trial
Official title:
Radiosurgery Versus Lobectomy for Temporal Lobe Epilepsy
This study will compare radiosurgery (focused radiation, Gamma Knife Radiosurgery) with temporal lobectomy (standard surgical care) as a treatment of temporal lobe epilepsy. Patients who have seizures that begin in their temporal lobe that are not controlled with medications into the trial will be offered entry. Patients with a high likelihood of having their seizures controlled with open surgery will have treatment randomized between the standard surgery and radiosurgery. A prior study has shown that focused radiation (radiosurgery) may also reduce or eliminate seizures arising from the temporal lobe. The main study hypothesis is that radiosurgery is as safe and effective as temporal lobectomy in treating patients with seizures arising from the medial temporal lobe.
The purpose of this study is to compare the effectiveness of Gamma Knife radiosurgery with
temporal lobectomy in the treatment of patients with drug resistant temporal lobe epilepsy.
Aim 1 is designed to compare the seizure-free outcomes and morbidity of radiosurgery for
patients with drug resistant temporal lobe epilepsy with those of open temporal lobectomy.
Our primary hypothesis is that radiosurgery will be non-inferior to lobectomy with respect to
seizure-free rates at 25-36 months following therapy (one-year of seizure freedom beginning 2
years after treatment).
Aim 2 is designed to compare the neuropsychological outcomes in patients undergoing
radiosurgery and temporal lobe surgery, in particular with respect to verbal memory function
for language-dominant hemisphere treated patients. Our hypothesis is that patients treated
for speech-dominant temporal lobe seizures with temporal lobectomy will show greater
reduction in verbal memory than patients treated with radiosurgery.
Aim 3 is designed to determine what changes occur in the quality of life of patients with
temporal lobe epilepsy following radiosurgical treatment as compared with open surgery. Our
primary hypothesis is that there will be improvements (comparing baseline with 3 years
post-treatment) in quality of life measures in both groups. Our secondary hypothesis is that
both open surgery and radiosurgery subjects will undergo transient reductions in quality of
life measures caused by treatment effects during the first year following treatment, but that
quality of life will improve for subjects who become seizure-free, independent of treatment
group.
Aim 4 is designed to compare the cost-effectiveness of radiosurgery compared with open
surgery. Specifically, the marginal cost-utility ratio will fall below $50,000/QALY, a
threshold thought to indicate that outcomes are considered worth the cost.
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