NCT02038998

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 15, 2023

Status Verified

October 1, 2021

Enrollment Period

7.3 years

First QC Date

December 30, 2013

Last Update Submit

February 14, 2023

Conditions

Cerebrovascular Stroke

Keywords

strokeperiodic accelerationendothelium releaseischemic penumbrashear stressadrenomedullin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Infarct volume

    7 days

Other Outcomes (1)

  • Blood markers

    0, 1, 3, 5, and 7ds

Study Arms (3)

Static group

SHAM COMPARATOR

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.

Device: Exer-Rest® TL

Single pGz intervention

EXPERIMENTAL

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.

Device: Exer-Rest® TL

Multiple pGz interventions

EXPERIMENTAL

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.

Device: Exer-Rest® TL

Interventions

Exer-Rest® TLDEVICE

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 interventionsSingle pGz interventionStatic group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San Pedro

Logroño, La Rioja, 26006, Spain

Location

Related 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.

    PMID: 19135137BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Francisco Julian-Villaverde, MD

    Hospital San Pedro de Logroño

    PRINCIPAL INVESTIGATOR

  • Alfredo Martinez, PhD

    Fundacion Rioja Salud

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group Leader

Study Record Dates

First Submitted

December 30, 2013

First Posted

January 17, 2014

Study Start

January 1, 2015

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

February 15, 2023

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)