Abstracts

BRAIN STIMULATION FOR EPILEPSY: PILOT PATIENT RESULTS AND IMPLEMENTATION OF A CONTROLLED CLINICAL TRIAL

Abstract number : 1.393
Submission category :
Year : 2004
Submission ID : 4421
Source : www.aesnet.org
Presentation date : 12/2/2004 12:00:00 AM
Published date : Dec 1, 2004, 06:00 AM

Authors :
1Nina M. Graves, 2Andres M. Lozano, 2Richard A. Wennberg, 3Ivan Osorio, 3Steven Wilkinson, 4Gordon Baluch, 4Jacqueline A. French, 5John F. Kerrigan, 5Andrew

Brain stimulation is a novel therapy that may be of use for people with medically-intractable seizures. To date, no definitive controlled trial of brain stimulation for epilepsy has been performed. In 1998 a group of investigators began collaboration on the design of studies to explore stimulation of the anterior nucleus of the thalamus (AN) in patients with uncontrolled seizures. Each investigator wrote a feasibility study to be implemented through their institution. Investigators have presented their individual findings at AES meetings and 2 manuscripts have been published (Hodaie 2002; Kerrigan 2004). This abstract presents collective results from these 14 patients, including previously unpublished data. The study designs prescribed intermittent high-frequency stimulation of the AN in patients with intractable epilepsy. Programmable neurostimulators (Medtronic ITREL II or Soletra) were implanted over the anterior chest wall, with bilateral implantation of the multi-contact electrodes into the AN. Stimulation parameters were allowed to vary. The patients (7M, 7F, ages 19-47) were from 4 clinical sites and have been followed for at least 12 months. Patients returned for visits at intervals specified by each protocol; seizure counts were monitored with a patient diary. Changes in seizure frequency were assessed relative to a pre-implantation (baseline) seizure frequency. During the first 3 months of AN stimulation, the median seizure frequency reduction, was 64% (sd 34%) in the 14 patients. Eight of these patients (57%) had a 50% or greater decrease in seizure frequency (responders). Over the 12-month period, the median reduction in total seizure frequency was 56% (sd 39%) with a responder rate of 57%. Nine of 14 patients had seizures presumed to arise from the temporal or frontal lobes. Over the first 3 months of stimulation, these 9 patients had a median 79% (sd 41%) reduction in seizure frequency and 78% of them were responders. Over the 12-month period, the median reduction in total seizure frequency was 59% (sd 47%) with a responder rate of 67%. Because of clinical and pre-clinical evidence of the possible efficacy of AN stimulation, this target has been chosen for a prospective, double-blind, parallel design safety and efficacy clinical trial. The design of this study will be presented.
Kerrigan JF et al. Epilepsia 45; 346-54, 2004.
Hodaie M et al. Epilepsia 43; 603-08, 2002. (Supported by Medtronic, Inc.)