Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy.
Adolescent
Adult
Aged
Depressive Disorder
/ epidemiology
Drug Resistant Epilepsy
/ physiopathology
Electric Stimulation Therapy
/ methods
Epilepsies, Partial
/ physiopathology
Female
Follow-Up Studies
Humans
Implantable Neurostimulators
Intracranial Hemorrhages
/ epidemiology
Male
Memory Disorders
/ epidemiology
Middle Aged
Prospective Studies
Prosthesis-Related Infections
/ epidemiology
Quality of Life
Randomized Controlled Trials as Topic
Status Epilepticus
/ epidemiology
Sudden Unexpected Death in Epilepsy
/ epidemiology
Suicide
/ statistics & numerical data
Treatment Outcome
Young Adult
Journal
Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060
Informations de publication
Date de publication:
01 09 2020
01 09 2020
Historique:
received:
21
03
2019
accepted:
06
03
2020
pubmed:
22
7
2020
medline:
27
10
2020
entrez:
22
7
2020
Statut:
ppublish
Résumé
To prospectively evaluate safety and efficacy of brain-responsive neurostimulation in adults with medically intractable focal onset seizures (FOS) over 9 years. 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. 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% ( 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. NCT00572195. This study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.
Identifiants
pubmed: 32690786
pii: WNL.0000000000010154
doi: 10.1212/WNL.0000000000010154
pmc: PMC7538230
doi:
Banques de données
ClinicalTrials.gov
['NCT00572195']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e1244-e1256Subventions
Organisme : NCI NIH HHS
ID : P30 CA023108
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001863
Pays : United States
Investigateurs
David King-Stephens
(D)
Cole A Giller
(CA)
Ki Hyeong Lee
(KH)
Mark R Lee
(MR)
Joseph R Smith
(JR)
Ellen L Air
(EL)
David E Burdette
(DE)
Konstantin V Elisevich
(KV)
Shailaja Gaddam
(S)
Andrea Sneider Hakimi
(AS)
Madhuri L Koganti
(ML)
Amit Ray
(A)
Jason M Schwalb
(JM)
Marianna V Spanaki-Varelas
(MV)
Vibhangini S Wasade
(VS)
Lisa M Caylor
(LM)
David G Vossler
(DG)
Joseph F Drazkowski
(JF)
Naresh P Patel
(NP)
Joseph I Sirven
(JI)
George I Jallo
(GI)
Eric H Kossoff
(EH)
Frederick A Lenz
(FA)
Eva Katharina Ritzl
(EK)
Rami G Apelian
(RG)
Vidya P Hawkins
(VP)
Laura A Kalayjian
(LA)
Brian Lee
(B)
Reed L Levine
(RL)
George Nune
(G)
Ron A Shatzmiller
(RA)
Parastou Shilian
(P)
Aamr A Herekar
(AA)
Kore K Liow
(KK)
Andrew D Massey
(AD)
Nazih Moufarrij
(N)
Evan J Fertig
(EJ)
Jason L Gerrard
(JL)
Alexander M Papanastassiou
(AM)
Imran Quraishi
(I)
Dennis D Spencer
(DD)
Susan S Spencer
(SS)
Kenneth P Vives
(KP)
David R Chabolla
(DR)
Kent C New
(KC)
Jerry J Shih
(JJ)
Richard W Byrne
(RW)
Thomas Hoeppner
(T)
Marvin A Rossi
(MA)
Michael C Smith
(MC)
Carl W Bazil
(CW)
Hyunmi Choi
(H)
Derek J Chong
(DJ)
Daniel L Friedman
(DL)
Robert R Goodman
(RR)
Mona Cheung
(M)
Ramon Diaz-Arrastia
(R)
Puneet K Gupta
(PK)
Ryan Hays
(R)
Bradley Lega
(B)
Christopher J Madden
(CJ)
Pradeep N Modur
(PN)
Paul C Van Ness
(PCV)
Louis Anthony Whitworth
(LA)
William E Bingaman
(WE)
Jehi Lara
(J)
Prakash Kotagal
(P)
Balu Krishnan
(B)
Joshua P Aronson
(JP)
Krzysztof A Bujarski
(KA)
Erik J Kobylarz
(EJ)
Richard P Morse
(RP)
Vijay M Thadani
(VM)
Nicholas Barbaro
(N)
Meridith A Runke
(MA)
Dragos Sabau
(D)
Robert M Worth
(RM)
Emad N Eskandar
(EN)
Daniel B Hoch
(DB)
Jeffrey W Britton
(JW)
Gregory D Cascino
(GD)
W R Marsh
(WR)
Steven Glazier
(S)
Justin M Nolte
(JM)
Mimi Sohn
(M)
William A Vandergrift
(WA)
James J Cereghino
(JJ)
Felicia A Ferguson
(FA)
Mary M Ransom
(MM)
Martin C Salinsky
(MC)
James J Evans
(JJ)
Scott E Mintzer
(SE)
Maromi Nei
(M)
Ashwini D Sharan
(AD)
Sanjiv Bhatia
(S)
Michael S Duchowny
(MS)
John Ragheb
(J)
Werner Doyle
(W)
Theodore Schwartz
(T)
Peter P Widdess-Walsh
(PP)
Robert A Gross
(RA)
John Craig Henry
(JC)
Lynn C Liu
(LC)
Webster H Pilcher
(WH)
Jason M Schwalb
(JM)
Olga Selioutski
(O)
Trent Tollefson
(T)
Thomas Wychowski
(T)
Azam S Ahmed
(AS)
John C Jones
(JC)
Raj D Sheth
(RD)
Karl A Sillay
(KA)
Evelyn C Tunnell
(EC)
Daniel Yoshor
(D)
Abdulrahman Alwaki
(A)
Charles M Epstein
(CM)
Rebecca Fasano
(R)
Raymond E Faught
(RE)
Sandra L Helmers
(SL)
Ioannis Karakis
(I)
Suzette M LaRoche
(SM)
Kimford J Meador
(KJ)
Andres A Rodriguez Ruiz
(AA)
Hannah Villarreal
(H)
Jon T. Willie
(JT)
James W Leiphart
(JW)
Samuel J Potolicchio
(SJ)
Cynthia L Harden
(CL)
Erik J Kobylarz
(EJ)
Mark S Quigg
(MS)
Edward Mader
(E)
Jean E Cibula
(JE)
William L Bell
(WL)
Daniel E Couture
(DE)
Thomas L Ellis
(TL)
Cormac A O'Donovan
(CA)
Maria C Sam
(MC)
Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
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