Feasibility and safety of lumbar puncture in the Parkinson's disease research participants: Parkinson's Progression Marker Initiative (PPMI).
Adverse events
Lumbar puncture
Parkinson's disease
Safety
Journal
Parkinsonism & related disorders
ISSN: 1873-5126
Titre abrégé: Parkinsonism Relat Disord
Pays: England
ID NLM: 9513583
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
18
10
2018
revised:
11
12
2018
accepted:
19
12
2018
pubmed:
11
2
2019
medline:
29
4
2020
entrez:
11
2
2019
Statut:
ppublish
Résumé
To determine the feasibility, safety and tolerability of lumbar punctures (LPs) in research participants with early Parkinson disease (PD), subjects without evidence of dopaminergic deficiency (SWEDDs) and healthy volunteers (HC). Cerebrospinal fluid (CSF) analysis is becoming an essential part of the biomarkers discovery effort in PD with still limited data on safety and feasibility of serial LPs in PD participants. Parkinson's Progression Marker Initiative (PPMI) is a longitudinal observation study designed to identify PD progression biomarkers. All PPMI participants undergo LP at baseline, 6, 12 months and yearly thereafter. CSF collection is performed by a trained investigator using predominantly atraumatic needles. Adverse events (AEs) are monitored by phone one week after LP completion. We analyzed safety data from baseline LPs. PPMI enrolled 683 participants (423 PD/196 HC/64 SWEDDs) from 23 study sites. CSF was collected at baseline in 97.5% of participants, of whom 5.4% underwent collection under fluoroscopy. 23% participants reported any related AEs, 68% of all AE were mild while 5.6% were severe. The most common AEs were headaches (13%) and low back pain (6.5%) and both occurred more commonly in HC and SWEDDs compared to PD participants. Factors associated with higher incidence of AEs across the cohorts included female gender, younger age and use of traumatic needles with larger diameter. AEs largely did not impact compliance with the future LPs. LPs are safe and feasible in PD research participants. Specific LP techniques (needle type and gauge) may reduce the overall incidence of AEs.
Sections du résumé
OBJECTIVE
To determine the feasibility, safety and tolerability of lumbar punctures (LPs) in research participants with early Parkinson disease (PD), subjects without evidence of dopaminergic deficiency (SWEDDs) and healthy volunteers (HC).
BACKGROUND
Cerebrospinal fluid (CSF) analysis is becoming an essential part of the biomarkers discovery effort in PD with still limited data on safety and feasibility of serial LPs in PD participants.
DESIGN/METHODS
Parkinson's Progression Marker Initiative (PPMI) is a longitudinal observation study designed to identify PD progression biomarkers. All PPMI participants undergo LP at baseline, 6, 12 months and yearly thereafter. CSF collection is performed by a trained investigator using predominantly atraumatic needles. Adverse events (AEs) are monitored by phone one week after LP completion. We analyzed safety data from baseline LPs.
RESULTS
PPMI enrolled 683 participants (423 PD/196 HC/64 SWEDDs) from 23 study sites. CSF was collected at baseline in 97.5% of participants, of whom 5.4% underwent collection under fluoroscopy. 23% participants reported any related AEs, 68% of all AE were mild while 5.6% were severe. The most common AEs were headaches (13%) and low back pain (6.5%) and both occurred more commonly in HC and SWEDDs compared to PD participants. Factors associated with higher incidence of AEs across the cohorts included female gender, younger age and use of traumatic needles with larger diameter. AEs largely did not impact compliance with the future LPs.
CONCLUSIONS
LPs are safe and feasible in PD research participants. Specific LP techniques (needle type and gauge) may reduce the overall incidence of AEs.
Identifiants
pubmed: 30738748
pii: S1353-8020(18)30559-5
doi: 10.1016/j.parkreldis.2018.12.025
pmc: PMC8978879
mid: NIHMS1789422
pii:
doi:
Substances chimiques
Biomarkers
0
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
201-209Subventions
Organisme : NINDS NIH HHS
ID : U01 NS084495
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002369
Pays : United States
Organisme : Intramural NIH HHS
ID : Z99 AG999999
Pays : United States
Organisme : NINDS NIH HHS
ID : U01 NS077108
Pays : United States
Organisme : NINDS NIH HHS
ID : U01 NS077352
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL091843
Pays : United States
Organisme : NINDS NIH HHS
ID : U01 NS082329
Pays : United States
Organisme : NINDS NIH HHS
ID : U01 NS079163
Pays : United States
Organisme : NINDS NIH HHS
ID : U01 NS038529
Pays : United States
Investigateurs
Kenneth Marek
(K)
Andrew Siderowf
(A)
John Seibyl
(J)
Christopher Coffey
(C)
Caroline Tanner
(C)
Duygu Tosun-Turgut
(D)
Tanya Simuni
(T)
Leslie Shaw
(L)
John Trojanowski
(J)
Andrew Singleton
(A)
Karl Kieburtz
(K)
Arthur Toga
(A)
Brit Mollenhauer
(B)
Douglas Galasko
(D)
Werner Poewe
(W)
Tatiana Foroud
(T)
Kathleen Poston
(K)
Todd Sherer
(T)
Sohini Chowdhury
(S)
Mark Frasier
(M)
Catherine Kopil
(C)
Vanessa Arnedo
(V)
Kenneth Marek
(K)
Nichole Daegele
(N)
Cynthia Casaceli
(C)
Ray Dorsey
(R)
Renee Wilson
(R)
Sugi Mahes
(S)
John Seibyl
(J)
Christina Salerno
(C)
Christopher Coffey
(C)
Chelsea Caspell-Garcia
(C)
Arthur Toga
(A)
Karen Crawford
(K)
Tatiana Foroud
(T)
Paola Casalin
(P)
Giulia Malferrari
(G)
Mali Gani Weisz
(MG)
Avi Orr-Urtreger
(A)
John Trojanowski
(J)
Leslie Shaw
(L)
Andrew Singleton
(A)
Tatiana Foroud
(T)
Tatiana Foroud
(T)
Thomas Montine
(T)
Tatiana Foroud
(T)
David Russell
(D)
Caroline Tanner
(C)
Tanya Simuni
(T)
Nabila Dahodwala
(N)
Brit Mollenhauer
(B)
Douglas Galasko
(D)
Werner Poewe
(W)
Nir Giladi
(N)
Stewart Factor
(S)
Penelope Hogarth
(P)
David Standaert
(D)
Robert Hauser
(R)
Joseph Jankovic
(J)
Marie Saint-Hilaire
(M)
Irene Richard
(I)
David Shprecher
(D)
Hubert Fernandez
(H)
Katrina Brockmann
(K)
Liana Rosenthal
(L)
Paolo Barone
(P)
Alberto Espay
(A)
Dominic Rowe
(D)
Karen Marder
(K)
Anthony Santiago
(A)
Susan Bressman
(S)
Shu-Ching Hu
(SC)
Stuart Isaacson
(S)
Jean-Christophe Corvol
(JC)
Javiar Ruiz Martinez
(JR)
Eduardo Tolosa
(E)
Yen Tai
(Y)
Marios Politis
(M)
Debra Smejdir
(D)
Linda Rees
(L)
Karen Williams
(K)
Farah Kausar
(F)
Karen Williams
(K)
Whitney Richardson
(W)
Diana Willeke
(D)
Shawnees Peacock
(S)
Beatrice Heim
(B)
Anat Mirelman
(A)
Barbara Sommerfeld
(B)
Alison Freed
(A)
Katrina Wakeman
(K)
Courtney Blair
(C)
Stephanie Guthrie
(S)
Leigh Harrell
(L)
Christine Hunter
(C)
Cathi-Ann Thomas
(CA)
Raymond James
(R)
Grace Zimmerman
(G)
Victoria Brown
(V)
Jennifer Mule
(J)
Ella Hilt
(E)
Kori Ribb
(K)
Susan Ainscough
(S)
Misty Wethington
(M)
Madelaine Ranola
(M)
Helen Mejia Santana
(HM)
Juliana Moreno
(J)
Deborah Raymond
(D)
Krista Speketer
(K)
Lisbeth Carvajal
(L)
Stephanie Carvalho
(S)
Ioana Croitoru
(I)
Alicia Garrido
(A)
Laura Marie Payne
(LM)
Veena Viswanth
(V)
Lawrence Severt
(L)
Maurizio Facheris
(M)
Holly Soares
(H)
Mark A Mintun
(MA)
Jesse Cedarbaum
(J)
Peggy Taylor
(P)
Kevin Biglan
(K)
Emily Vandenbroucke
(E)
Zulfiqar Haider Sheikh
(ZH)
Baris Bingol
(B)
Tanya Fischer
(T)
Pablo Sardi
(P)
Remi Forrat
(R)
Alastair Reith
(A)
Jan Egebjerg
(J)
Gabrielle Ahlberg Hillert
(GA)
Barbara Saba
(B)
Chris Min
(C)
Robert Umek
(R)
Joe Mather
(J)
Susan De Santi
(S)
Anke Post
(A)
Frank Boess
(F)
Kirsten Taylor
(K)
Igor Grachev
(I)
Andreja Avbersek
(A)
Pierandrea Muglia
(P)
Kaplana Merchant
(K)
Johannes Tauscher
(J)
Informations de copyright
Copyright © 2019 Elsevier Ltd. All rights reserved.
Références
J Alzheimers Dis. 2014;39(4):719-26
pubmed: 24254700
Cochrane Database Syst Rev. 2017 Apr 07;4:CD010807
pubmed: 28388808
Spine J. 2015 Jan 1;15(1):115-21
pubmed: 25041726
Alzheimer Dis Assoc Disord. 2017 Oct-Dec;31(4):287-294
pubmed: 28891819
Lancet. 2018 Mar 24;391(10126):1197-1204
pubmed: 29223694
Curr Alzheimer Res. 2009 Jun;6(3):290-2
pubmed: 19519311
Mov Disord. 2018 May;33(5):771-782
pubmed: 29572948
Alzheimer Dis Assoc Disord. 2005 Oct-Dec;19(4):220-5
pubmed: 16327349
Mov Disord Clin Pract. 2016 Jul 18;3(6):538-547
pubmed: 30363567
Alzheimers Dement. 2016 Feb;12(2):154-163
pubmed: 26368321
Front Aging Neurosci. 2014 Apr 09;6:65
pubmed: 24782762
J Clin Neurosci. 2014 Mar;21(3):536-7
pubmed: 24156907
Neurology. 2002 Dec 24;59(12):2008-9
pubmed: 12499507