Status:
WITHDRAWN
PLAsticity, Security and Tolerance to Intermittent Hypoxic Conditioning Following Stroke
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Agir pour les maladies chroniques
Conditions:
Stroke, Ischemic
Stroke Sequelae
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief 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 n...
Detailed Description
Stroke is the second leading cause of death and the third leading cause of disability-adjusted life-years worldwide. If acute stroke therapy has decreased mortality, more than 50% of stroke survivors ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05210088
Start Date
January 1 2024
End Date
January 1 2024
Last Update
June 4 2024
Active Locations (1)
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1
Grenoble Aalpes University Hospital
Grenoble, Veuillez Sélectionner Une Région., France, 38000