Abstracts

We present an interim report for the SANTE (Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy) trial, to illustrate the structure of the trial., The subject pool consists of patients 18-65 years old, inclusive, with partial onset seizures with or without generalization, and with observable clinical seizure manifestations. Seizures must be documented by prior video-EEG monitoring, and they must average at least six per month. Patients must have failed at least three AEDs, with dosing stable for 30 days prior to enrollment. Women must be using a reliable method of birth control. Excluded are patients with IQ[lt]70 or inability to complete neuropsychological testing, progressive lesions or diseases, or psychiatric hospitalization, suicide attempt or psychosis (excluding postictal psychosis) within five years. If present, a VNS is to be explanted at time of thalamic implantation. After a three-month baseline, eligible subjects receive bilateral anterior thalamic nuclei implantation of a dual-channel Medtronic Model 7428 Kinetra Neurostimulation System with Model 3387 DBS Brain Leads. One month later, stimulation is initiated at either 0 (placebo) or 5 (active treatment) V, with pulse width 90 us, 145 pulses per second, on for 1 minute and off for 5. The double-blind period continued for 3 months, after which there is 9 months of systematic variation of certain stimulation parameters., As of 3/27/06, 98 patients were enrolled and 58 implanted at 15 US medical centers. Of these, 25 discontinued prior to implantation. Reasons included withdrawal of consent, inability to maintain stable antiepileptic drugs, status epilepticus, insufficient numbers of seizures in the baseline, and miscellaneous other reasons. Among 85 patients completing the baseline visit, age (mean [plusmn] SD, range) was 35.4 [plusmn] 10.9 (18.5-60.9) years, 45 male, 40 female. Epilepsy duration was 22.2 [plusmn] 13.1 (2-60) years. AEDs numbered 1 in 9 patients (11.3%), 2 in 37 (46.3%), 3 in 32 (40.0%), and 4 in 2 (2.5%). A vagus nerve stimulator previously had been implanted in 36 (42.4%); 17 (20.0%) had prior epilepsy surgery and 12 had both epilepsy surgery and VNS implantation., The SANTE trial is proceeding satisfactorily. Efficacy and safety data will be analyzed and presented after 102 patients have completed the blinded phase., (Supported by Medtronic.)