The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical research allows you to play an active role in developing future treatments for many disorders of the brain and nervous system. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.
The overall purpose of this study is to compare the effectiveness of Gamma Knife radiosurgery with temporal lobectomy in the treatment of people with drug resistant temporal lobe epilepsy. This study has 4 aims.
Aim 1 will compare the seizure-free outcomes and morbidity of radiosurgery for people with drug resistant temporal lobe epilepsy with those of open temporal lobectomy. The investigators hypothesize that radiosurgery will not be 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 will compare the neuropsychological outcomes in people undergoing radiosurgery and temporal lobe surgery, in particular with respect to verbal memory function for language-dominant hemisphere treated people. The investigators hypothesize that people treated for speech-dominant temporal lobe seizures with temporal lobectomy will show greater reduction in verbal memory than those treated with radiosurgery.
Aim 3 will determine what changes occur in the quality of life of people with temporal lobe epilepsy following radiosurgical treatment as compared with open surgery. The primary hypothesis is that there will be improvements (comparing baseline with 3 years post-treatment) in quality of life measures in both groups. The secondary hypothesis is that both people treated with open surgery and those treated with radiosurgery 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 people who become seizure-free, independent of treatment group.
Aim 4 will compare the cost-effectiveness of radiosurgery compared with open surgery. The investigators hypothesize that the marginal cost-utility ratio will fall below $50,000/QALY, a threshold thought to indicate that outcomes are considered worth the cost.
Please follow this link for trial eligibility information to share with your doctor.
Interventional; Purpose: Treatment
Multiple US Locations
Contact: Nicholas M. Barbaro, MD; Tel: 317 396-1283; Email: firstname.lastname@example.org; Mark Quigg, MD; Tel: 434-924-5312; Email: email@example.com; Mariann Ward, NP; Tel: 415-353-2347; Email: firstname.lastname@example.org
Last Reviewed July 13, 2012