Neurology. 2015 Mar 10;84(10):1017-25. doi: 10.1212/WNL.0000000000001334. Epub 2015 Feb 6.

Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy.

Salanova V¹, Witt T², Worth R², Henry TR², Gross RE², Nazzaro JM², Labar D², Sperling MR², Sharan A², Sandok E², Handforth A², Stern JM², Chung S², Henderson JM², French J², Baltuch G², Rosenfeld WE², Garcia P², Barbaro NM², Fountain NB², Elias WJ², Goodman RR², Pollard JR², Tröster AI², Irwin CP², Lambrecht K², Graves N², Fisher R²; SANTE Study Group.

Collaborators (5)

Epstein C, King J, Osorio I, Bakay R, Bergen D.

Author information

1: From Indiana University (V.S., T.W., R.W., N.M.B.), Indianapolis; University of Minnesota (T.R.H.), Minneapolis; Emory University (R.E.G.), Atlanta, GA; University of Kansas (J.M.N.), Kansas City; Weill Cornell (D.L.), New York, NY; Thomas Jefferson University (M.R.S., A.S.), Philadelphia, PA; Marshfield Clinic (E.S.), WI; Veterans Affairs Greater Los Angeles Healthcare System (A.H.); Geffen School of Medicine at UCLA (J.M.S.), Los Angeles, CA; Barrow Neurological Institute (S.C., A.I.T.), Phoenix, AZ; Stanford University (J.M.H., R.F.), CA; NYU Comprehensive Epilepsy Center (J.F.), New York, NY; University of Pennsylvania (G.B., J.R.P.), PA; St. Luke's (W.E.R.), St. Louis, MO; University of California San Francisco (P.G.); University of Virginia School of Medicine (N.B.F., W.J.E.), Charlottesville; Mount Sinai (R.R.G.), New York, NY; and Medtronic, Inc. (C.P.I., K.L., N.G.), Minneapolis, MN. vsalanov@iupui.edu.
2: From Indiana University (V.S., T.W., R.W., N.M.B.), Indianapolis; University of Minnesota (T.R.H.), Minneapolis; Emory University (R.E.G.), Atlanta, GA; University of Kansas (J.M.N.), Kansas City; Weill Cornell (D.L.), New York, NY; Thomas Jefferson University (M.R.S., A.S.), Philadelphia, PA; Marshfield Clinic (E.S.), WI; Veterans Affairs Greater Los Angeles Healthcare System (A.H.); Geffen School of Medicine at UCLA (J.M.S.), Los Angeles, CA; Barrow Neurological Institute (S.C., A.I.T.), Phoenix, AZ; Stanford University (J.M.H., R.F.), CA; NYU Comprehensive Epilepsy Center (J.F.), New York, NY; University of Pennsylvania (G.B., J.R.P.), PA; St. Luke's (W.E.R.), St. Louis, MO; University of California San Francisco (P.G.); University of Virginia School of Medicine (N.B.F., W.J.E.), Charlottesville; Mount Sinai (R.R.G.), New York, NY; and Medtronic, Inc. (C.P.I., K.L., N.G.), Minneapolis, MN.

Abstract

OBJECTIVE:

To report long-term efficacy and safety results of the SANTE trial investigating deep brain stimulation of the anterior nucleus of the thalamus (ANT) for treatment of localization-related epilepsy.

METHODS:

This long-term follow-up is a continuation of a previously reported trial of 5- vs 0-V ANT stimulation. Long-term follow-up began 13 months after device implantation with stimulation parameters adjusted at the investigators' discretion. Seizure frequency was determined using daily seizure diaries.

RESULTS:

The median percent seizure reduction from baseline at 1 year was 41%, and 69% at 5 years. The responder rate (≥50% reduction in seizure frequency) at 1 year was 43%, and 68% at 5 years. In the 5 years of follow-up, 16% of subjects were seizure-free for at least 6 months. There were no reported unanticipated adverse device effects or symptomatic intracranial hemorrhages. The Liverpool Seizure Severity Scale and 31-item Quality of Life in Epilepsy measure showed statistically significant improvement over baseline by 1 year and at 5 years (p < 0.001).

CONCLUSION:

Long-term follow-up of ANT deep brain stimulation showed sustained efficacy and safety in a treatment-resistant population.

CLASSIFICATION OF EVIDENCE:

This long-term follow-up provides Class IV evidence that for patients with drug-resistant partial epilepsy, anterior thalamic stimulation is associated with a 69% reduction in seizure frequency and a 34% serious device-related adverse event rate at 5 years.