Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: Final results of the RNS System Pivotal trial

被引：472

作者：

Heck, Christianne N. ^{[1
]}

King-Stephens, David ^{[2
]}

Massey, Andrew D. ^{[3
]}

Nair, Dileep R. ^{[4
]}

Jobst, Barbara C. ^{[5
]}

Barkley, Gregory L. ^{[6
]}

Salanova, Vicenta ^{[7
]}

Cole, Andrew J. ^{[8
]}

Smith, Michael C. ^{[9
]}

Gwinn, Ryder P. ^{[10
]}

Skidmore, Christopher ^{[11
]}

Van Ness, Paul C. ^{[12
]}

Bergey, Gregory K. ^{[13
]}

Park, Yong D. ^{[14
]}

Miller, Ian ^{[15
]}

Geller, Eric ^{[16
]}

Rutecki, Paul A. ^{[17
]}

Zimmerman, Richard ^{[18
]}

Spencer, David C. ^{[19
]}

Goldman, Alica ^{[20
]}

Edwards, Jonathan C. ^{[21
]}

Leiphart, James W. ^{[22
]}

Wharen, Robert E. ^{[23
]}

Fessler, James ^{[24
]}

Fountain, Nathan B. ^{[25
]}

Worrell, Gregory A. ^{[26
]}

Gross, Robert E. ^{[27
]}

Eisenschenk, Stephan ^{[28
]}

Duckrow, Robert B. ^{[29
]}

Hirsch, Lawrence J. ^{[29
]}

Bazil, Carl ^{[30
]}

O'Donovan, Cormac A. ^{[31
]}

Sun, Felice T. ^{[32
]}

Courtney, Tracy A. ^{[32
]}

Seale, Cairn G. ^{[32
]}

Morrell, Martha J. ^{[32
,33
]}

机构：

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

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

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

[4] Cleveland Clin Fdn, Cleveland, OH 44195 USA

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

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

[7] IU Sch Med, Indianapolis, IN USA

[8] Massachusetts Gen Hosp, Epilepsy Serv, Boston, MA 02114 USA

[9] Rush Univ Med Ctr, Chicago, IL USA

[10] Seattle Neurosci Inst, Seattle, WA USA

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

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

[13] Johns Hopkins Med, Dept Neurol, Baltimore, MD USA

[14] Georgia Regents Univ, Augusta, GA USA

[15] Miami Childrens Hosp, Miami, FL USA

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

[17] Univ Wisconsin, WA Middleton VA Hosp, Madison, WI USA

[18] Mayo Clin Arizona, Phoenix, AZ USA

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

[20] Baylor Coll Med, Peter Kellaway Sect Neurophysiol Neurol, Houston, TX 77030 USA

[21] Med Univ S Carolina, Charleston, SC 29425 USA

[22] George Washington Univ, Washington, DC USA

[23] Mayo Clin Florida, Jacksonville, FL USA

[24] Univ Rochester, Rochester, NY USA

[25] Univ Virginia Sch Med, Dept Neurol, Charlottesville, VA USA

[26] Mayo Clin, Sect Electroencephalog, Rochester, MN USA

[27] Emory Univ, Atlanta, GA 30322 USA

[28] Univ Florida, Gainesville, FL USA

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

[30] Columbia Presbyterian Med Ctr, New York, NY 10032 USA

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

[32] NeuroPace, Mountain View, CA USA

[33] Stanford Univ, Stanford, CA 94305 USA

来源：

EPILEPSIA | 2014年 / 55卷 / 03期

关键词：

Cortical stimulation; Partial seizures; Focal seizures; Responsive stimulation; Neurostimulator; QUALITY-OF-LIFE; VAGUS NERVE-STIMULATION; TEMPORAL-LOBE; LONG-TERM; STANDARDS-SUBCOMMITTEE; ELECTRICAL-STIMULATION; ADJUNCTIVE THERAPY; AMERICAN-ACADEMY; DOUBLE-BLIND; EFFICACY;

D O I：

10.1111/epi.12534

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

ObjectiveTo demonstrate the safety and effectiveness of responsive stimulation at the seizure focus as an adjunctive therapy to reduce the frequency of seizures in adults with medically intractable partial onset seizures arising from one or two seizure foci. MethodsRandomized multicenter double-blinded controlled trial of responsive focal cortical stimulation (RNS System). Subjects with medically intractable partial onset seizures from one or two foci were implanted, and 1month postimplant were randomized 1:1 to active or sham stimulation. After the fifth postimplant month, all subjects received responsive stimulation in an open label period (OLP) to complete 2years of postimplant follow-up. ResultsAll 191 subjects were randomized. The percent change in seizures at the end of the blinded period was -37.9% in the active and -17.3% in the sham stimulation group (p=0.012, Generalized Estimating Equations). The median percent reduction in seizures in the OLP was 44% at 1year and 53% at 2years, which represents a progressive and significant improvement with time (p<0.0001). The serious adverse event rate was not different between subjects receiving active and sham stimulation. Adverse events were consistent with the known risks of an implanted medical device, seizures, and of other epilepsy treatments. There were no adverse effects on neuropsychological function or mood. SignificanceResponsive stimulation to the seizure focus reduced the frequency of partial-onset seizures acutely, showed improving seizure reduction over time, was well tolerated, and was acceptably safe. The RNS System provides an additional treatment option for patients with medically intractable partial-onset seizures.

引用

页码：432 / 441

页数：10

共 40 条

[31]

Silberbusch MA, 1998, AM J NEURORADIOL, V19, P1089

[32] COMBINED DEPTH AND SUBDURAL ELECTRODE INVESTIGATION IN UNCONTROLLED EPILEPSY [J].