Radiosurgery or Open Surgery for Epilepsy Trial

Summary

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.

Conditions

• Epilepsy

Interventions

PROCEDURE

radiosurgery

The stereotaxic frame will be secured to the skull with four pins. Patients will be taken to the MRI unit and receive a stereotaxic MRI. MRI data will be transferred to the Gamma Knife computer. Each patient will receive radiation to the mesial temporal lobe during a single treatment session. The amygdala and anterior 2cm of the hippocampus as well as the immediately adjacent parahippocampal gyrus will be included in the radiosurgical target. Patients will receive 24Gy to the 50% isodose line using an unlimited number of isocenters. The brainstem and optic nerve plus chiasm will receive less than 10 Gy and 8 Gy, respectively. After treatment, the stereotaxic frame will be removed from the patient's head.

PROCEDURE

temporal lobectomy

The temporal lobectomy will be performed under general anesthesia. The superior temporal gyrus will be resected to a minimal degree (typically between 1 and 2cm) and the middle and inferior temporal gyri will be resected to approximately 3cm.The minimum amount of lateral temporal cortex required to perform an aggressive resection of medial temporal structures will be performed. The temporal portion of the amygdala and the anterior two to three cm of the hippocampus will be resected. In addition, nearby entorhinal cortex will be removed.

Sponsors & Collaborators

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Lawrence Ver Hoef, MD · University of Alabama at Birmingham

• Guy McKhann, MD · Columbia University

• Vincenta Salanova, MD · Indiana University

• Thomas Pittman, MD · University of Kentucky

• Andriana E. Palade, MD · West Virginia University

• Aviva Abosch, MD, PhD · University of Minnesota

• Anto Bagic, MD, MSc · University of Pittsburgh, Medical School

• Robert L Beach, MD, PhD · Upstate Medical University

• Evelyn S Tecoma, MD, PhD · University of California, San Diego

• Christi N Heck, MD, PhD · University of Southern California

• John W Miller, MD, PhD · University of Washington

• Nathan B Fountain, MD · University of Virginia

• Paul Garcia, MD · University of California, San Francisco

• Nicholas M. Barbaro, MD · University of California, San Francisco

• Mark S Quigg, MD, MSc · University of Virginia

• Kenneth D Laxer, MD · California Pacific Medical Center

• John Langfitt, MA, PhD · University of Rochester

• Penny Sneed, MD · University of California, San Francisco

• Michael W McDermott, MD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2016-06-01

Completion

2016-07-01

Countries

• United States
• India

Study Locations