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A Multimodal Imaging- and Stimulation-based Method of Evaluating Connectivity-related Brain Excitability in Patients with Epilepsy
Published on: November 13, 2016
Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy
Dileep R Nair1, Kenneth D Laxer1, Peter B Weber1
1From the Cleveland Clinic Foundation (D.R.N., A.V.A.), OH; California Pacific Medical Center (K.D.L., P.B.W.), San Francisco; Augusta University (A.M.M., Y.D.P.), GA; Henry Ford Hospital (G.L.B.), Detroit, MI; Ohio Health Neuroscience (B.J.S.), Columbus; Swedish Neuroscience Institute (R.P.G., M.J.D.), Seattle, WA; Mayo Clinic Arizona (K.H.N., R.S.Z.), Scottsdale; Johns Hopkins Medicine (G.K.B., W.S.A.), Baltimore, MD; Keck School of Medicine of USC (C.H., C.Y.L.), Los Angeles, CA; Via Christi Epilepsy Center (R.W.L., T.S.), Wichita, KS; Yale University School of Medicine (R.B.D., L.J.H.), New Haven, CT; Mayo Clinic Florida (R.E.W., W.T.), Jacksonville; Columbia University Medical Center (S.S., G.M.M.), New York, NY; University of Texas Southwestern Medical Center (M.A.A.), Dallas; Geisel School of Medicine at Dartmouth (B.C.J., D.W.R.), Hanover, NH; Indiana University School of Medicine (V.S., T.C.W.), Indianapolis; Massachusetts General Hospital (S.S.C., A.J.C.), Boston; Mayo Clinic Minnesota (G.A.W., B.N.L.), Rochester; Medical University of South Carolina (J.C.E., J.J.H.), Charleston; Oregon Health & Science University (D.C. Spencer, L.E.), Portland; Thomas Jefferson University (C.T.S., M.R.S.), Philadelphia, PA; Nicklaus Children's Hospital (I.M.), Miami, FL; Saint Barnabas Medical Center (E.B.G.), Livingston, NJ; University of Rochester Medical Center (M.J.B., A.J.F.), NY; University of Wisconsin Hospital and Clinics (P.R.), Madison; Baylor College of Medicine (A.M.G., E.M.M.), Houston, TX; Emory University School of Medicine (R.E.G.), Atlanta, GA; George Washington University School of Medicine and Health Sciences (D.C. Shields), Washington, DC; Weill Cornell Medical College (T.H.S., D.R.L.), New York, NY; University of Virginia School of Medicine (N.B.F., W.J.E.), Charlottesville; Louisiana State University Health Sciences Center (P.W.O., N.R.V.-P.), New Orleans; University of Florida (S.E., S.N.R.), Gainesville; Wake Forest University Health Sciences (J.G.B.), Winston-Salem, NC; NeuroPace, Inc (T.A.C., F.T.S., C.G.S., K.L.M., T.L.S., M.J.M.), Mountain View; and Stanford University (M.J.M.), Palo Alto, CA.
Objective:
To prospectively evaluate safety and efficacy of brain-responsive neurostimulation in adults with medically intractable focal onset seizures (FOS) over 9 years.
Methods:
Adults treated with brain-responsive neurostimulation in 2-year feasibility or randomized controlled trials were enrolled in a long-term prospective open label trial (LTT) to assess safety, efficacy, and quality of life (QOL) over an additional 7 years. Safety was assessed as adverse events (AEs), efficacy as median percent change in seizure frequency and responder rate, and QOL with the Quality of Life in Epilepsy (QOLIE-89) inventory.
Results:
Of 256 patients treated in the initial trials, 230 participated in the LTT. At 9 years, the median percent reduction in seizure frequency was 75% (p < 0.0001, Wilcoxon signed rank), responder rate was 73%, and 35% had a ≥90% reduction in seizure frequency. We found that 18.4% (47 of 256) experienced ≥1 year of seizure freedom, with 62% (29 of 47) seizure-free at the last follow-up and an average seizure-free period of 3.2 years (range 1.04-9.6 years). Overall QOL and epilepsy-targeted and cognitive domains of QOLIE-89 remained significantly improved (p < 0.05). There were no serious AEs related to stimulation, and the sudden unexplained death in epilepsy (SUDEP) rate was significantly lower than predefined comparators (p < 0.05, 1-tailed χ2).
Conclusions:
Adjunctive brain-responsive neurostimulation provides significant and sustained reductions in the frequency of FOS with improved QOL. Stimulation was well tolerated; implantation-related AEs were typical of other neurostimulation devices; and SUDEP rates were low.
Clinicaltrialsgov Identifier:
NCT00572195.
Classification Of Evidence:
This study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.
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