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

Study Overview
=================
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.

Official Title
-----------------
Unicentric, Phase II, Randomized Study Comparing Periodic Acceleration Versus Static Position in Cerebrovascular Stroke Patients

Conditions
-----------------
Cerebrovascular Stroke

Intervention / Treatment
-----------------
* Device: Exer-Rest® TL


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Static group<br>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. | Device: Exer-Rest® TL<br>* 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.<br>|
| Experimental: Single pGz intervention<br>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. | Device: Exer-Rest® TL<br>* 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.<br>|
| Experimental: Multiple pGz interventions<br>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. | Device: Exer-Rest® TL<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct volume | Infarct volume will be measured by nuclear magnetic resonance 7 days after stroke | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adrenomedullin, stroke, periodic acceleration, endothelium release, ischemic penumbra, shear stress