Randomized controlled trial of intermittent hypoxia in Parkinson's disease: study rationale and protocol.

Autor: Janssen Daalen JM; Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Center of Expertise for Parkinson & Movement Disorders, Nijmegen, The Netherlands. Jules.M.JanssenDaalen@radboudumc.nl.; Radboud University Medical Center, Department of Medical BioSciences, Nijmegen, The Netherlands. Jules.M.JanssenDaalen@radboudumc.nl., Meinders MJ; Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Center of Expertise for Parkinson & Movement Disorders, Nijmegen, The Netherlands., Mathur S; UnshakeableMD, Oshawa, ON, Canada., van Hees HWH; Radboud University Medical Center, Department of Pulmonary Diseases, Nijmegen, The Netherlands., Ainslie PN; University of British Columbia, Center for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, Kelowna, Canada., Thijssen DHJ; Radboud University Medical Center, Department of Medical BioSciences, Nijmegen, The Netherlands., Bloem BR; Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Center of Expertise for Parkinson & Movement Disorders, Nijmegen, The Netherlands. Bas.Bloem@radboudumc.nl.
Jazyk: angličtina
Zdroj: BMC neurology [BMC Neurol] 2024 Jun 22; Vol. 24 (1), pp. 212. Date of Electronic Publication: 2024 Jun 22.
DOI: 10.1186/s12883-024-03702-3
Abstrakt: Background: Parkinson's disease (PD) is a neurodegenerative disease for which no disease-modifying therapies exist. Preclinical and clinical evidence suggest that repeated exposure to intermittent hypoxia might have short- and long-term benefits in PD. In a previous exploratory phase I trial, we demonstrated that in-clinic intermittent hypoxia exposure is safe and feasible with short-term symptomatic effects on PD symptoms. The current study aims to explore the safety, tolerability, feasibility, and net symptomatic effects of a four-week intermittent hypoxia protocol, administered at home, in individuals with PD.
Methods/design: This is a two-armed double-blinded randomized controlled trial involving 40 individuals with mild to moderate PD. Participants will receive 45 min of normobaric intermittent hypoxia (fraction of inspired oxygen 0.16 for 5 min interspersed with 5 min normoxia), 3 times a week for 4 weeks. Co-primary endpoints include nature and total number of adverse events, and a feasibility-tolerability questionnaire. Secondary endpoints include Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II and III scores, gait tests and biomarkers indicative of hypoxic dose and neuroprotective pathway induction.
Discussion: This trial builds on the previous phase I trial and aims to investigate the safety, tolerability, feasibility, and net symptomatic effects of intermittent hypoxia in individuals with PD. Additionally, the study aims to explore induction of relevant neuroprotective pathways as measured in plasma. The results of this trial could provide further insight into the potential of hypoxia-based therapy as a novel treatment approach for PD.
Trial Registration: ClinicalTrials.gov Identifier: NCT05948761 (registered June 20th, 2023).
(© 2024. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje