Cerebrovascular Stroke
Conditions
Keywords
stroke, periodic acceleration, endothelium release, ischemic penumbra, shear stress, adrenomedullin
Brief summary
Stroke is one of the leading causes of death and disability worldwide. More than 85% of strokes are due to blood vessel occlusion resulting in partial destruction of the brain parenchyma. Current protocols try to re-establish blood circulation as soon as possible through chemical and/or mechanical interventions but new strategies are needed. Periodic acceleration (pGz) is a non-invasive method consisting in the application of a rocking movement to the patient that ultimately will induce the release of beneficial chemicals from the vascular endothelium (the cells lining the inside of the blood vessels). Application of pGz in an animal model of stroke resulted in a dramatic reduction of associated brain damage. This trial will investigate whether stroke patients exposed to pGz experiment significantly higher recovery than patients that remained static during their treatment.
Detailed description
Periodic acceleration (pGz) is a non-invasive method consisting in the application of a rocking movement to the patient that ultimately will induce the release of beneficial chemicals from the vascular endothelium (the cells lining the inside of the blood vessels). Application of pGz in an animal model of stroke resulted in a dramatic reduction of associated brain damage. This trial will investigate whether stroke patients exposed to pGz experiment significantly higher recovery than patients that remained static during their treatment.
Interventions
DEVICEExer-Rest® TL
Exer-Rest® TL is a therapeutic motorized platform that allows the application of pGz forces to a patient. The typical application would provide an acceleration of 0.4 Gz.
Sponsors
Hospital San Pedro de Logroño
Fundacion Rioja Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A signed informed consent form must be obtained prior to recruitment * Patients with symptoms of acute ischemic stroke * Less than 12 hours from initiation of the stroke * Age: 18 years or older * Capable of following the protocol
Exclusion criteria
* Pregnant or lactating women, and women that do not follow a contraceptive plan and may become pregnant * Less than 18 years of age * More than 12 hours from the initiation of the stroke or when the initiation time is unknown. * Hemorrhagic stroke * Candidates to receive thrombolytic treatment * Spine traumatism or other conditions that may be aggravated by pGz * Patients that cannot be properly followed because of phycological, social, familiar, or geographical reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIHSS and Rankin scales | 0hr, 2hr, 24hr, 48hr, 7ds, 90ds | The NIHSS and Rankin scales will be applied to the patients at the indicated times |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infarct volume | 7 days | Infarct volume will be measured by nuclear magnetic resonance 7 days after stroke |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood markers | 0, 1, 3, 5, and 7ds | Neuroprotective substances that can be released by pGz (nitric oxide, tissue plasminogen activator, adrenomedullin, prostaglandins, etc) will be measured in the blood of patients to investigate the efficacy of the treatment. |
Countries
Spain
Outcome results
None listed