Clinical trial NCT02038998: Randomized Study Comparing Periodic Acceleration Versus Static Position in Cerebrovascular Stroke Patients
Official title: Unicentric, Phase II, Randomized Study Comparing Periodic Acceleration Versus Static Position in Cerebrovascular Stroke Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cerebrovascular Stroke
Keywords: stroke
periodic acceleration
endothelium release
ischemic penumbra
shear stress
adrenomedullin
Lead sponsor: Fundacion Rioja Salud
Sponsor class: OTHER
Collaborators: name: Hospital San Pedro de Logroño
First posted: 2014-01-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: NIHSS and Rankin scales
timeFrame: 0hr, 2hr, 24hr, 48hr, 7ds, 90ds
Secondary outcomes:
measure: Infarct volume
timeFrame: 7 days
Other outcomes:
measure: Blood markers
timeFrame: 0, 1, 3, 5, and 7ds
Locations:
city: Logroño
country: Spain
facility: Hospital San Pedro
state: La Rioja
Study officials:
affiliation: Hospital San Pedro de Logroño
name: Francisco Julian-Villaverde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacion Rioja Salud
name: Alfredo Martinez, PhD
role: STUDY_DIRECTOR
References:
citation: 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.