PLAsticity, Security and Tolerance to Intermittent Hypoxic Conditioning Following Stroke

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborator: Agir pour les maladies chroniques

Criteria

Inclusion Criteria:

• Patients with minor cerebral infarction with NIHSS < or equal to 5 will be included in the protocol;

• Cerebral infarction occurring one month (±1 week) before the planned start of hypoxic exposure;

• Age ≥18 years;

• A first, unilateral, ischemic, supra-tentorial hemispheric stroke, confirmed by magnetic resonance imaging;

• Modified Rankin Scale score between 1 and 3, defining mild to moderate residual functional disability.

• A person affiliated with the social security system or benefits from such a system;

• A person who has given written informed consent.

Exclusion Criteria:

• Patients who are minors or over 85 years of age, pregnant or breastfeeding women, or women of childbearing potential in the absence of highly effective contraception;

• Stroke of the brainstem or cerebellum ;

• Severe aphasia, limiting the ability to understand the protocol;

• History of central or peripheral neurological pathology;

• Modified Rankin Scale score >0 before stroke;

• Known severe untreated obstructive sleep apnea syndrome, defined as an apnea-hypopnea index ≥ 30 events per hour of sleep;

• Pre-existing hypoxemic lung disease (such as chronic obstructive pulmonary disease);

• Heart failure, defined as an ejection fraction ≤40% ;

• History of high altitude pathology;

• Scheduled stay at altitude (> 2500 m) during the study period ;

• Migraine;

• History of rheumatological or orthopedic disease of the lower limbs, amputation of the lower limb.

• Contraindication to magnetic resonance imaging;

• Subjects who cannot be contacted in an emergency;

• Subject in exclusion period of another study;

• Subject under administrative or judicial supervision;

• Persons referred to in Articles L1121-5 to L1121-8 of the "Code de la Santé Publique" (corresponds to all protected persons: pregnant women, women in labor, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure).