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PLAsticity, Security and Tolerance to Intermittent Hypoxic Conditioning Following Stroke

NCT05210088 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2024-06-04

No results posted yet for this study

Summary

By inducing endogenous neuroprotection, hypoxic post-conditioning following stroke may represent a harmless and efficient non-pharmacological innovative neuro-therapeutic modality aiming at inducing neuroplasticity and brain repair, as supported by many preclinical studies.

The investigators thus hypothesize that hypoxic post-conditioning represents a safe therapeutic strategy post-stroke. The investigators further hypothesize that hypoxic conditioning could enhance neuroplasticity and function in combination with conventional rehabilitative care.

The primary study endpoint will be safety. Safety will be assessed through the clinical review of the adverse events over the duration of the study, every 48 hours by a trained evaluator, blinded for the therapeutic intervention.

The investigators will further investigate the potential functional benefits of such a therapeutic approach on motor function, gait, balance, and cognition. The neurophysiological substrates of hypoxic conditioning-triggered neuroplasticity at a subacute delay post-stroke will also be investigated, based on biological and imagery markers.

Conditions

  • Stroke, Ischemic
  • Stroke Sequelae

Interventions

DRUG

Hypoxia, intermittent

The device used to generate the intermittent hypoxia stimulus is a gas mixer used in current clinical practice and research (Altitrainer®, SMTEC S.A. Switzerland). The hypoxic stimulus will be obtained by having the subject inhale a gas mixture enriched in nitrogen by means of a mask, in variable proportion according to the desired degree of hypoxia. Hypoxic conditioning will be performed in three one-hour sessions per week, performed non-consecutively, for 8 weeks. The hypoxic stimulus will be intermittent, and each session will consist of 7 cycles of 5 minutes of hypoxia alternating with 3 minutes of normoxia (FiO2 = 21%). The subjects will be installed in a semi-recumbent position, at rest in a quiet environment. For hypoxic exposure, the inspired fraction of oxygen (FiO2) will be set individually to achieve the targeted level of desaturation (Pulse Oxygen Saturation, SpO2) continuously monitored.

OTHER

Normoxia

The normoxic stimulus will be obtained by having the subjects inhale via a face mask a normoxic gas mixture with a fixed FiO2 of 21%, delivered by the gas mixing device (Altitrainer®, SMTEC S.A. Switzerland).

Sponsors & Collaborators

  • Agir pour les maladies chroniques

    collaborator UNKNOWN

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Sébastien BAI, MD PHD · CHU Grenoble Alpes

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-01-01
Completion
2024-01-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05210088 on ClinicalTrials.gov