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| Name | Class |
|---|---|
| Hospital San Pedro de Logroño | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Static group | Sham Comparator | Control group. They will receive the standard care provided by the protocols of the ictus unit. They will lay on the Exer-Rest® TL device but the acceleration will NOT be connected. |
|
| Single pGz intervention | Experimental | In addition to the standard care established in the ictus unit, these patients will receive a single exposure to pGz on the Exer-Rest® TL, for 3 hours, during the first day of their stay in the hospital. |
|
| Multiple pGz interventions | Experimental | In addition to the standard care, these patients will be exposed to 45 minutes of pGz, on the Exer-Rest® TL, every day during their first week in the Hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exer-Rest® TL | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS and Rankin scales | The NIHSS and Rankin scales will be applied to the patients at the indicated times | 0hr, 2hr, 24hr, 48hr, 7ds, 90ds |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct volume | Infarct volume will be measured by nuclear magnetic resonance 7 days after stroke | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Blood markers | 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. | 0, 1, 3, 5, and 7ds |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Julian-Villaverde, MD | Hospital San Pedro de Logroño | Principal Investigator |
| Alfredo Martinez, PhD | Fundacion Rioja Salud | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Pedro | Logroño | La Rioja | 26006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19135137 | Background | Martinez-Murillo R, Serrano J, Fernandez AP, Martinez A. Whole-body periodic acceleration reduces brain damage in a focal ischemia model. Neuroscience. 2009 Feb 18;158(4):1390-6. doi: 10.1016/j.neuroscience.2008.12.005. Epub 2008 Dec 14. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |