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

Not Applicable

Withdrawn

• Conditions: Cerebrovascular Stroke

• Registration Number: NCT02038998
• Lead Sponsor: Fundacion Rioja Salud

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.

Study Timeline

• Study First Submitted: 2013-12-30
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-17
• Study Start: 2015-01
• Status Verified: 2021-10
• Primary Completion: 2022-05
• Study Completion: 2022-06
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Hospital San Pedro; 🇪🇸 Logroño, La Rioja, Spain