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

Cerebrovascular Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02038998
• Other study ID #: CIBIR002
• Status: Withdrawn
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 2022

Study information

• Verified date: October 2021
• Source: Fundacion Rioja Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Stroke
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	Hospital San Pedro	Logroño	La Rioja

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion Rioja Salud	Hospital San Pedro

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood markers	Neuroprotective substances that can be released by pGz (nitric oxide, tissue plasminogen activator, adrenomedullin, prostaglandins, etc) will be measured in the blood of patients to investigate the efficacy of the treatment.	0, 1, 3, 5, and 7ds
Primary	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	Infarct volume	Infarct volume will be measured by nuclear magnetic resonance 7 days after stroke	7 days