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

NCT ID: NCT02038998

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2022-06-30

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.

Conditions

Cerebrovascular Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Static group

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.

Group Type: SHAM_COMPARATOR

Exer-Rest® TL

Intervention Type: 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.

Single pGz intervention

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.

Group Type: EXPERIMENTAL

Exer-Rest® TL

Intervention Type: 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.

Multiple pGz interventions

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.

Group Type: EXPERIMENTAL

Exer-Rest® TL

Intervention Type: 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.

Interventions

Exer-Rest® TL

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital San Pedro de Logroño

OTHER

Sponsor Role: collaborator

Fundacion Rioja Salud

OTHER

Sponsor Role: lead

Responsible Party

Alfredo Martinez

Group Leader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco Julian-Villaverde, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Pedro de Logroño

Alfredo Martinez, PhD

Role: STUDY_DIRECTOR

Fundacion Rioja Salud

Locations

Hospital San Pedro

Logroño, La Rioja, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 19135137 (View on PubMed)

Other Identifiers

CIBIR002

Identifier Type: -

Identifier Source: org_study_id