Cerebrovascular StrokeNCT02038998
Randomized Study Comparing Periodic Acceleration Versus Static Position in Cerebrovascular Stroke Patients
A study testing Exer-Rest® TL in people with Cerebrovascular Stroke, run by Fundacion Rioja Salud at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Stroke
- What is being tested?
- Exer-Rest® TL
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unicentric, Phase II, Randomized Study Comparing Periodic Acceleration Versus Static Position in Cerebrovascular Stroke Patients
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.
Read the 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
- Being tested
- Exer-Rest® TL
- Keywords
- stroke, periodic acceleration, endothelium release, ischemic penumbra, shear stress, adrenomedullin
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Exer-Rest® TL |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIHSS and Rankin scales
The NIHSS and Rankin scales will be applied to the patients at the indicated times
Measured: 0hr, 2hr, 24hr, 48hr, 7ds, 90ds
Secondary outcomes (1)
Infarct volume
Infarct volume will be measured by nuclear magnetic resonance 7 days after stroke
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startJan 2015
- Primary completionMay 2022
- Study completionJun 2022
Why it stopped: Lack of available patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Rioja Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital San Pedro de Logroño
- Responsible party
- Principal investigator, Alfredo Martinez, Fundacion Rioja Salud
- Investigators
- Francisco Julian-Villaverde, MD, Principal investigator, Hospital San Pedro de LogroñoAlfredo Martinez, PhD, Study director, Fundacion Rioja Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038998
- Sponsor's protocol ID
- CIBIR002
- Status last verified
- Oct 2021
- First submitted
- 30 Dec 2013
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19135137
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unicentric, Phase II, Randomized Study Comparing Periodic Acceleration Versus Static Position in Cerebrovascular Stroke Patients
- ClinicalTrials.gov ID
- NCT02038998
- Acronym / sponsor ID
- CIBIR002
- Conditions
- Cerebrovascular Stroke
- Keywords
- stroke, periodic acceleration, endothelium release, ischemic penumbra, shear stress, adrenomedullin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of available patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundacion Rioja SaludUniversity, hospital or other
- Collaborators
- Hospital San Pedro de Logroño
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Static group | Sham comparator | Device: Exer-Rest® TLControl 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. |
| Single pGz intervention | Experimental | Device: Exer-Rest® TLIn 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. |
| Multiple pGz interventions | Experimental | Device: Exer-Rest® TLIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exer-Rest® TLExer-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. | Device | Multiple pGz interventions, Single pGz intervention, Static group |
Primary outcome
NIHSS and Rankin scales
Time frame: 0hr, 2hr, 24hr, 48hr, 7ds, 90ds
The NIHSS and Rankin scales will be applied to the patients at the indicated times
1 secondary outcome
Infarct volume
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 19135137Martinez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Julian-Villaverde, MD principal investigator
Hospital San Pedro de Logroño
Alfredo Martinez, PhD study director
Fundacion Rioja Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exer-Rest® TL in people with Cerebrovascular Stroke, run by Fundacion Rioja Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIHSS and Rankin scales (time frame: 0hr, 2hr, 24hr, 48hr, 7ds, 90ds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02038998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.