Long-term treatment with responsive brain stimulation in adults with refractory partial seizures

被引：458

作者：

Bergey, Gregory K. ^{[1
]}

Morrell, Martha J. ^{[2
,35
]}

Mizrahi, Eli M. ^{[3
]}

Goldman, Alica ^{[3
]}

King-Stephens, David ^{[4
]}

Nair, Dileep ^{[5
]}

Srinivasan, Shraddha ^{[6
]}

Jobst, Barbara ^{[7
]}

Gross, Robert E. ^{[8
]}

Shields, Donald C. ^{[9
]}

Barkley, Gregory ^{[10
]}

Salanova, Vicenta ^{[11
]}

Olejniczak, Piotr ^{[12
]}

Cole, Andrew ^{[13
]}

Cash, Sydney S. ^{[13
]}

Noe, Katherine ^{[14
]}

Wharen, Robert ^{[15
]}

Worrell, Gregory ^{[16
]}

Murro, Anthony M. ^{[17
]}

Edwards, Jonathan ^{[18
]}

Duchowny, Michael ^{[19
]}

Spencer, David ^{[20
]}

Smith, Michael ^{[21
]}

Geller, Eric ^{[22
]}

Gwinn, Ryder ^{[23
]}

Skidmore, Christopher ^{[24
]}

Eisenschenk, Stephan ^{[25
]}

Berg, Michel ^{[26
]}

Heck, Christianne ^{[27
]}

Van Ness, Paul ^{[28
]}

Fountain, Nathan ^{[29
]}

Rutecki, Paul ^{[30
]}

Massey, Andrew ^{[31
]}

O'Donovan, Cormac ^{[32
]}

Labar, Douglas ^{[33
]}

Duckrow, Robert B. ^{[34
]}

Hirsch, Lawrence J. ^{[34
]}

Courtney, Tracy ^{[35
]}

Sun, Felice T. ^{[35
]}

Seale, Cairn G. ^{[35
]}

机构：

[1] Johns Hopkins Med, Baltimore, MD USA

[2] Stanford Univ, Stanford, CA 94305 USA

[3] Baylor Coll Med, Houston, TX 77030 USA

[4] Calif Pacific Med Ctr, San Francisco, CA USA

[5] Cleveland Clin Fdn, Cleveland, OH USA

[6] Columbia Univ, Med Ctr, New York, NY USA

[7] Dartmouth Hitchcock Med Ctr, Lebanon, NH 03766 USA

[8] Emory Univ, Atlanta, GA 30322 USA

[9] George Washington Univ, Washington, DC USA

[10] Henry Ford Hosp, Detroit, MI 48202 USA

[11] Indiana Univ Sch Med, Indianapolis, IN 46202 USA

[12] Louisiana State Univ, Hlth Sci Ctr, New Orleans, LA USA

[13] Massachusetts Gen Hosp, Boston, MA 02114 USA

[14] Mayo Clin Arizona, Scottsdale, AZ USA

[15] Mayo Clin Florida, Jacksonville, FL USA

[16] Mayo Clin Rochester, Rochester, MN USA

[17] Georgia Regents Univ, Augusta, GA USA

[18] Med Univ S Carolina, Charleston, SC USA

[19] Miami Childrens Hosp, Miami, FL USA

[20] Oregon Hlth & Sci Univ, Portland, OR 97201 USA

[21] Rush Univ, Med Ctr, Chicago, IL 60612 USA

[22] Inst Neurol & Neurosurg St Barnabas, Livingston, NJ USA

[23] Swedish Neurosci Inst, Seattle, WA USA

[24] Thomas Jefferson Univ, Philadelphia, PA 19107 USA

[25] Univ Florida, Gainesville, FL USA

[26] Univ Rochester, Rochester, NY 14627 USA

[27] Univ So Calif, Los Angeles, CA USA

[28] Univ Texas SW Med Ctr Dallas, Dallas, TX 75390 USA

[29] Univ Virginia, Sch Med, Charlottesville, VA 22908 USA

[30] Univ Wisconsin, Madison, WI 53706 USA

[31] Via Christi Comprehens Epilepsy Ctr, Wichita, KS USA

[32] Wake Forest Univ, Winston Salem, NC 27109 USA

[33] Cornell Univ, Weill Med Coll, New York, NY 10021 USA

[34] Yale Univ, Sch Med, New Haven, CT USA

[35] NeuroPace, Mountain View, CA USA

来源：

NEUROLOGY | 2015年 / 84卷 / 08期

关键词：

VAGUS NERVE-STIMULATION; QUALITY-OF-LIFE; HIGH-FREQUENCY STIMULATION; SUDDEN UNEXPECTED DEATH; PARTIAL-ONSET SEIZURES; AMERICAN-ACADEMY; TEMPORAL-LOBE; STANDARDS-SUBCOMMITTEE; ANTIEPILEPTIC DRUGS; ADJUNCTIVE THERAPY;

D O I：

10.1212/WNL.0000000000001280

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

100204 [神经病学];

摘要：

Objective:The long-term efficacy and safety of responsive direct neurostimulation was assessed in adults with medically refractory partial onset seizures.Methods:All participants were treated with a cranially implanted responsive neurostimulator that delivers stimulation to 1 or 2 seizure foci via chronically implanted electrodes when specific electrocorticographic patterns are detected (RNS System). Participants had completed a 2-year primarily open-label safety study (n = 65) or a 2-year randomized blinded controlled safety and efficacy study (n = 191); 230 participants transitioned into an ongoing 7-year study to assess safety and efficacy.Results:The average participant was 34 (11.4) years old with epilepsy for 19.6 (11.4) years. The median preimplant frequency of disabling partial or generalized tonic-clonic seizures was 10.2 seizures a month. The median percent seizure reduction in the randomized blinded controlled trial was 44% at 1 year and 53% at 2 years (p < 0.0001, generalized estimating equation) and ranged from 48% to 66% over postimplant years 3 through 6 in the long-term study. Improvements in quality of life were maintained (p < 0.05). The most common serious device-related adverse events over the mean 5.4 years of follow-up were implant site infection (9.0%) involving soft tissue and neurostimulator explantation (4.7%).Conclusions:The RNS System is the first direct brain responsive neurostimulator. Acute and sustained efficacy and safety were demonstrated in adults with medically refractory partial onset seizures arising from 1 or 2 foci over a mean follow-up of 5.4 years. This experience supports the RNS System as a treatment option for refractory partial seizures.Classification of evidence:This study provides Class IV evidence that for adults with medically refractory partial onset seizures, responsive direct cortical stimulation reduces seizures and improves quality of life over a mean follow-up of 5.4 years.

引用

页码：810 / 817

页数：8

共 40 条

[1]

[Anonymous], 2012, Epilepsy across the spectrum: Promoting health and understanding, DOI [DOI 10.17226/13379, 10.17226/13379]

[2]

Surgical and neurological complications in a series of 708 epilepsy surgery procedures [J].