TY - JOUR
T1 - Feasibility and safety of lumbar puncture in the Parkinson's disease research participants
T2 - Parkinson's Progression Marker Initiative (PPMI)
AU - The Parkinson's Progression Markers InitiativeSteering Committee
AU - Study Cores
AU - Site Investigators
AU - Coordinators
AU - Industry and Scientific Advisory Board
AU - Prakash, Neha
AU - Caspell-Garcia, Chelsea
AU - Coffey, Christopher
AU - Siderowf, Andrew
AU - Tanner, Caroline M.
AU - Kieburtz, Karl
AU - Mollenhauer, Brit
AU - Galasko, Douglas
AU - Merchant, Kalpana
AU - Foroud, Tatiana
AU - Chahine, Lana M.
AU - Weintraub, Daniel
AU - Casaceli, Cindy
AU - Dorsey, Ray
AU - Wilson, Renee
AU - Herzog, Margaret
AU - Daegele, Nichole
AU - Arnedo, Vanessa
AU - Frasier, Mark
AU - Sherer, Todd
AU - Marek, Ken
AU - Frank, Samuel
AU - Jennings, Danna
AU - Simuni, Tanya
AU - Marek, Kenneth
AU - Seibyl, John
AU - Tanner, Caroline
AU - Tosun-Turgut, Duygu
AU - Shaw, Leslie
AU - Trojanowski, John
AU - Singleton, Andrew
AU - Toga, Arthur
AU - Poewe, Werner
AU - Poston, Kathleen
AU - Chowdhury, Sohini
AU - Kopil, Catherine
AU - Casaceli, Cynthia
AU - Mahes, Sugi
AU - Salerno, Christina
AU - Crawford, Karen
AU - Casalin, Paola
AU - Malferrari, Giulia
AU - Weisz, Mali Gani
AU - Orr-Urtreger, Avi
AU - Montine, Thomas
AU - Russell, David
AU - Dahodwala, Nabila
AU - Giladi, Nir
AU - Factor, Stewart
AU - Mirelman, Anat
N1 - Publisher Copyright:
© 2019 Elsevier Ltd
PY - 2019/5
Y1 - 2019/5
N2 - 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.
AB - 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.
KW - Adverse events
KW - Lumbar puncture
KW - Parkinson's disease
KW - Safety
UR - https://www.scopus.com/pages/publications/85061045418
U2 - 10.1016/j.parkreldis.2018.12.025
DO - 10.1016/j.parkreldis.2018.12.025
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C2 - 30738748
AN - SCOPUS:85061045418
SN - 1353-8020
VL - 62
SP - 201
EP - 209
JO - Parkinsonism and Related Disorders
JF - Parkinsonism and Related Disorders
ER -