Feasibility and safety of lumbar puncture in the Parkinson's disease research participants

Parkinson's Progression Marker Initiative (PPMI)

The Parkinson's Progression Markers InitiativeSteering Committee, Study Cores, Site Investigators, Coordinators, Industry and Scientific Advisory Board

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
JournalParkinsonism and Related Disorders
DOIs
StatePublished - Jan 1 2019
Externally publishedYes

Fingerprint

Spinal Puncture
Parkinson Disease
Safety
Research
Needles
Cerebrospinal Fluid
Biomarkers
Fluoroscopy
Incidence
Low Back Pain
Headache
Longitudinal Studies
Disease Progression
Healthy Volunteers
Research Personnel
Observation

Keywords

  • Adverse events
  • Lumbar puncture
  • Parkinson's disease
  • Safety

ASJC Scopus subject areas

  • Neurology
  • Geriatrics and Gerontology
  • Clinical Neurology

Cite this

The Parkinson's Progression Markers InitiativeSteering Committee, Study Cores, Site Investigators, Coordinators, & Industry and Scientific Advisory Board (2019). Feasibility and safety of lumbar puncture in the Parkinson's disease research participants: Parkinson's Progression Marker Initiative (PPMI). Parkinsonism and Related Disorders. https://doi.org/10.1016/j.parkreldis.2018.12.025

Feasibility and safety of lumbar puncture in the Parkinson's disease research participants : Parkinson's Progression Marker Initiative (PPMI). / The Parkinson's Progression Markers InitiativeSteering Committee; Study Cores; Site Investigators; Coordinators; Industry and Scientific Advisory Board.

In: Parkinsonism and Related Disorders, 01.01.2019.

Research output: Contribution to journalArticle

The Parkinson's Progression Markers InitiativeSteering Committee, Study Cores, Site Investigators, Coordinators & Industry and Scientific Advisory Board 2019, 'Feasibility and safety of lumbar puncture in the Parkinson's disease research participants: Parkinson's Progression Marker Initiative (PPMI)', Parkinsonism and Related Disorders. https://doi.org/10.1016/j.parkreldis.2018.12.025
The Parkinson's Progression Markers InitiativeSteering Committee, Study Cores, Site Investigators, Coordinators, Industry and Scientific Advisory Board. Feasibility and safety of lumbar puncture in the Parkinson's disease research participants: Parkinson's Progression Marker Initiative (PPMI). Parkinsonism and Related Disorders. 2019 Jan 1. https://doi.org/10.1016/j.parkreldis.2018.12.025
The Parkinson's Progression Markers InitiativeSteering Committee ; Study Cores ; Site Investigators ; Coordinators ; Industry and Scientific Advisory Board. / Feasibility and safety of lumbar puncture in the Parkinson's disease research participants : Parkinson's Progression Marker Initiative (PPMI). In: Parkinsonism and Related Disorders. 2019.
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abstract = "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.",
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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 - 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 - Hogarth, Penelope

AU - Standaert, David

AU - Hauser, Robert

PY - 2019/1/1

Y1 - 2019/1/1

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

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