Randomized Study Comparing Periodic Acceleration Versus Static Position in Cerebrovascular Stroke Patients

N/AWithdrawnNCT02038998

Fundacion Rioja Salud

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Cerebrovascular Stroke

Interventions

Exer-Rest® TLDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital San Pedro

Logroño, La Rioja, Spain

Outcomes

Primary Outcomes

NIHSS and Rankin scales

The NIHSS and Rankin scales will be applied to the patients at the indicated times

Time frame: 0hr, 2hr, 24hr, 48hr, 7ds, 90ds

Secondary Outcomes

Infarct volume

Infarct volume will be measured by nuclear magnetic resonance 7 days after stroke

Time frame: 7 days

Data from ClinicalTrials.gov

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