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

Primary Purpose

Cerebrovascular Stroke

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exer-Rest® TL
Sponsored by
Fundacion Rioja Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Stroke focused on measuring stroke, periodic acceleration, endothelium release, ischemic penumbra, shear stress, adrenomedullin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital San Pedro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Static group

Single pGz intervention

Multiple pGz interventions

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

NIHSS and Rankin scales
The NIHSS and Rankin scales will be applied to the patients at the indicated times

Secondary Outcome Measures

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

Full Information

First Posted
December 30, 2013
Last Updated
February 14, 2023
Sponsor
Fundacion Rioja Salud
Collaborators
Hospital San Pedro de Logroño
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1. Study Identification

Unique Protocol Identification Number
NCT02038998
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of available patients
Study Start Date
January 2015 (Actual)
Primary Completion Date
May 2022 (Actual)
Study Completion Date
June 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Rioja Salud
Collaborators
Hospital San Pedro de Logroño

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Stroke
Keywords
stroke, periodic acceleration, endothelium release, ischemic penumbra, shear stress, adrenomedullin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Static group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Single pGz intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Multiple pGz interventions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Exer-Rest® TL
Intervention Description
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.
Primary Outcome Measure Information:
Title
NIHSS and Rankin scales
Description
The NIHSS and Rankin scales will be applied to the patients at the indicated times
Time Frame
0hr, 2hr, 24hr, 48hr, 7ds, 90ds
Secondary Outcome Measure Information:
Title
Infarct volume
Description
Infarct volume will be measured by nuclear magnetic resonance 7 days after stroke
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Blood markers
Description
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.
Time Frame
0, 1, 3, 5, and 7ds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Julian-Villaverde, MD
Organizational Affiliation
Hospital San Pedro de Logroño
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alfredo Martinez, PhD
Organizational Affiliation
Fundacion Rioja Salud
Official's Role
Study Director
Facility Information:
Facility Name
Hospital San Pedro
City
Logroño
State/Province
La Rioja
ZIP/Postal Code
26006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19135137
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.
Results Reference
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Randomized Study Comparing Periodic Acceleration Versus Static Position in Cerebrovascular Stroke Patients

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