Journal article
Feasibility and safety of lumbar puncture in the Parkinson's disease research participants: Parkinson's Progression Marker Initiative (PPMI)
Parkinsonism & related disorders, Vol.62, pp.201-209
05/2019
DOI: 10.1016/j.parkreldis.2018.12.025
PMCID: PMC8978879
PMID: 30738748
Abstract
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.
Details
- Title: Subtitle
- Feasibility and safety of lumbar puncture in the Parkinson's disease research participants: Parkinson's Progression Marker Initiative (PPMI)
- Creators
- Neha Prakash - Northwestern University Feinberg School of Medicine, USA. Electronic address: neha.prakash@northwestern.eduChelsea Caspell-Garcia - The University of Iowa, USA. Electronic address: chelsea-caspell@uiowa.eduChristopher Coffey - The University of Iowa, USA. Electronic address: christopher-coffey@uiowa.eduAndrew Siderowf - The University of Pennsylvania, USA. Electronic address: Andrew.siderowf@uphs.upenn.eduKarl Kieburtz - University of Rochester Medical Center, USA. Electronic address: karl.kieburtz@chet.rochester.eduBrit Mollenhauer - Center of Parkinsonism and Movement Disorders Paracelsus-Elena Klinik Kassel and University Medical Center Goettingen, Germany. Electronic address: brit.mollenhauer@med.uni-goettingen.deDouglas Galasko - University of California San Diego, USA. Electronic address: dgalasko@ucsd.eduKalpana Merchant - TransThera Consulting, USA. Electronic address: merchant.transthera@gmail.comTatiana Foroud - Indiana University, USA. Electronic address: tforoud@iu.eduLana M Chahine - University of Pittsburgh, USA. Electronic address: lanachahine@pitt.eduDaniel Weintraub - The University of Pennsylvania, USA. Electronic address: daniel.weintraub@uphs.penn.eduCindy Casaceli - University of Rochester Medical Center, USA. Electronic address: cindy.casaceli@chet.rochester.eduRay Dorsey - University of Rochester Medical Center, USA. Electronic address: ray.dorsey@chet.rochester.eduRenee Wilson - Clinical Trial Coordination Center, University of Rochester Medical Center, USA. Electronic address: renee.wilson@chet.rochester.eduMargaret Herzog - Michael J Fox Foundation, USANichole Daegele - Institute for Neurodegenerative Disorders, USA. Electronic address: ndaegele@invicro.comVanessa Arnedo - Michael J Fox Foundation, USA. Electronic address: varnedo@michaeljfox.orgMark Frasier - Michael J Fox Foundation, USA. Electronic address: mfrasier@michaeljfox.orgTodd Sherer - Michael J Fox Foundation, USA. Electronic address: tsherer@michaeljfox.orgKen Marek - Institute for Neurodegenerative Disorders, USA. Electronic address: kmarek@mnimaging.comSamuel Frank - Harvard Medical School, Beth Israel Deaconess Medical Center, Parkinson's Disease and Movement Disorders Center, Director of the HDSA Center of Excellence, USA. Electronic address: sfrank2@bidmc.harvard.eduDanna Jennings - Denali Therapeutics, USA. Electronic address: jennings@dnli.comTanya Simuni - Northwestern University Feinberg School of Medicine, USA. Electronic address: tsimuni@nmff.orgParkinson's Progression Markers Initiative Steering Committee
- Resource Type
- Journal article
- Publication Details
- Parkinsonism & related disorders, Vol.62, pp.201-209
- DOI
- 10.1016/j.parkreldis.2018.12.025
- PMID
- 30738748
- PMCID
- PMC8978879
- NLM abbreviation
- Parkinsonism Relat Disord
- ISSN
- 1353-8020
- eISSN
- 1873-5126
- Grant note
- U01 NS077352 / NINDS NIH HHS U01 NS038529 / NINDS NIH HHS U01 NS079163 / NINDS NIH HHS U01 NS082329 / NINDS NIH HHS R01 HL091843 / NHLBI NIH HHS U01 NS084495 / NINDS NIH HHS U01 NS077108 / NINDS NIH HHS
- Language
- English
- Date published
- 05/2019
- Academic Unit
- Biostatistics
- Record Identifier
- 9984214666602771
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