Stroke, Acute IschemicNCT05408130
Remote Ischemic Conditioning With Novel Optical Sensor Feedback Device in Acute Ischemic Stroke
A study testing Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device in people with Stroke, Acute Ischemic and Small Vessel Cerebrovascular Disease, run by University of Alberta at 1 site in Canada.
Trial summary
Stroke is a leading cause of physical and cognitive disabilities. The most common type of stroke is ischemic (lack of blood flow to the brain due to clot blocking a blood vessel). Many people with stroke (PwS) have changes on the brain imaging called small vessel disease (SVD). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Acute Ischemic, Small Vessel Cerebrovascular Disease
- What is being tested?
- Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jul 2022to 1 Aug 2024
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with ischemic stroke (anterior and posterior circulation involvement) with or without neurological deficit within 48h of symptom onset
- CT head or MRI Brain evidence of infarct
- CT head or MRI Brain evidence of moderate or severe small vessel disease. We will assess atrophy, leukoaraiosis and old vascular lesions.
- Premorbid functional disability assessed by mRS <2
- National institute of Health Stroke scale <15 at the time of enrollment
Who cannot join
- Patient is part of other clinical trial delivering intervention
- Injury to the upper arm or any other musculoskeletal disability/pain precluding from tolerating RIC therapy
- Treatment of ongoing malignancy with expected survival < 6 months
- Presence of hypertensive urgency and emergency
- Presence of hemodynamic instability
- Presence of ongoing systemic infection with antibiotic therapy
- Pregnant and lactating women
- History of dermatological conditions affecting application of tissue perfusion sensor and remote ischemic conditioning pressure cuff
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is a leading cause of physical and cognitive disabilities. The most common type of stroke is ischemic (lack of blood flow to the brain due to clot blocking a blood vessel). Many people with stroke (PwS) have changes on the brain imaging called small vessel disease (SVD). This is a condition that affects tiny blood vessels supplying the brain, leading to decreased blood flow in some parts of the brain. These brain changes may hamper the recovery process after stroke, or lead to recurrent stroke and cognitive impairment. SVD is a slow process that can be seen as multiple black spots on computed tomography or white spots on magnetic resonance imaging. Current treatments to reduce the effect of SVD on PwS are to control high blood pressure, high blood sugar, high cholesterol and increase physical activity. However, these approaches do not lead to a reduction in SVD.
Remote Ischemic Conditioning is a type of treatment delivered with help of a regular blood pressure machine. This does not involve any drug. A typical treatment involves the application of a blood pressure cuff followed by brief sessions of compressions and relaxation on the arm muscles much akin to blood pressure measurement but for 5 min. It leads to a transient safe state of less blood flow in arm muscles which initiates the release of molecules and signals transmitted by blood. These signals may then go on to improve blood flow in the brain. Recent animal and human studies have suggested that the use of RIC may reduce the SVD load.
Read more
A new device will be used to deliver remote ischemic conditioning therapy in a better manner. Existing devices generate the same amount of compression for all people. The pressure applied by the machine in the arm may be either more than required or less than required. The ideal compression would be one that achieves a low blood flow state in the arm at the least possible pressure. To achieve this our group is using a small light sensor to inform us. The light sensor is closely applied to the skin over the arm below the blood pressure cuff. It emits light that is absorbed by the skin and the light is then reflected. This is detected by other sensors placed together. From the reflected light the sensor can obtain information about blood flow in the skin. When the pressure increases with help of an automated machine the light sensor can detect that blood flow are reduced and this information is displayed on the computer. The information about skin blood flow will inform about the level of pressure to apply to give accurate treatment.
The new device with optical feedback will deliver RIC in PwS and SVD in a safe and reliable manner. A total of 51 patients will take part in this study. Thirty-four will get remote ischemic conditioning therapy and 17 patients will get sham-control therapy. All patients will get standard post-stroke treatment according to the Canadian Stroke Best Practices Recommendation.
Read the detailed description
- Hypothesis In patients with ischemic stroke and small vessel disease, Remote Ischemic Conditioning (RIC) delivered by novel device with optical feedback sensor will be safe and feasible.
- Rationale Cerebral small vessel disease (SVD) is highly prevalent in aging societies and also in patients with ischemic stroke.SVD is independently associated with cognitive impairment and incidence of stroke.SVD is characterised by presence of white matter lesions (commonly seen as hyperintensities on magnetic resonance imaging (MRI) or hypodensities on computed tomography, CT), microbleeds, prominent perivascular spaces, lacunar infarcts and intracerebral hemorrhages. Risk of worse outcomes in patients with ischemic stroke as assessed by modified Rankin scale (mRS) >2 is increased by odds ratio (OR) of 1.96 if there is a presence of white-matter hyperintensities (WMH). Furthermore, WMH are also associated with increased risk of recurrent stroke (OR 1.93), cognitive impairment (OR 2.22) and all-cause mortality (OR1.82). Current standard of care focuses on control of vascular risk factors including hypertension, diabetes, dyslipidemia, smoking, physical activity and mental health concerns to reduce the impact of WMH on stroke outcomes. There is no targeted therapy available for reducing the burden of SVD.
RIC involves brief cyclic ischemia (5 minutes, inflation of BP cuff) and reperfusion (5 minutes, deflation of BP cuff) of a distant organ (arm muscles) to protect at-risk (cerebral tissue) organ tissue by increasing ischemia tolerance. In experimental stroke RIC alone or in combination revascularization therapy may have additive effect, improve collateral circulation and reduce the infarct size.Human clinical trial in ischemic stroke have been promising so far. In animal models for vascular contributions to cognitive impairment and dementia (VCID) RIC for 1 month demonstrated improved cerebral blood flow, prevented white matter damage, improved angiogenesis and cognitive outcomes. In a pilot human study RIC for 1 year lead to reduction in WMH.
An important ongoing issue is the fidelity of RIC delivered to the patients. Typically for ischemia to develop in the limb muscles, current standard practice is to increase the pressure in the limb 30-50 mmHg above the systolic blood pressure to maximum of 200 mmHg. However, this may be variable in individual subjects. Pressure in upper limb may be associated with discomfort and consequent reduced compliance.An effective solution would be to identify ideal pressure target for each individual person. Our group is developing a novel RIC device, which will identify precise BP target with optical feedback sensor to deliver optimal ischemia with least possible pressure. This will improve patient experience and improve fidelity of RIC.
- Being tested
- Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device, Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device
- Keywords
- remote ischemic conditioning, stroke, small vessel cerebrovascular disease
- Medical subject headings
- Ischemic Stroke, Cerebral Small Vessel Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic Conditioning with Novel Optical Sensor Feedback DeviceDevice
All patients randomized to intervention arm will receive 5 cycles of ischemia/reperfusion in non-paralysed upper limb or if no upper limb paralysis non-dominant arm. They will receive it once daily for a period of 7 days or during hospital stay whichever is shorter.
Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback DeviceDevice
In the sham group subjects will receive pressure sensation by keeping the pressure at 30 mmHg for 3 min in both arms All patients in sham and intervention group will receive standard of care management for ischemic stroke
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device | Experimental | All patients randomized to the intervention arm will receive 5 cycles of ischemia/reperfusion in the non-paralyzed upper limb or if no upper limb paralysis non-dominant arm. They will receive it once daily for a period of 7 days or during hospital stay whichever is shorter. Receives: Device: Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device |
| Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device | Sham comparator | In the sham group subjects will receive pressure sensation by keeping the pressure at 30 mmHg for 3 min in both arms All patients in sham and intervention group will receive standard of care management for ischemic stroke. Receives: Device: Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert scale
The primary outcome measure is the safety and feasibility of RIC delivered during the first 7 days or at the time of discharge. In safety, we will assess the level of comfort with the Likert scale. The Likert scale will be divided into 5 levels very comfortable, comfortable, neither comfortable nor uncomfortable, uncomfortable and very uncomfortable. In safety, we would assess pain or any persistent bruises.
Measured: at 7 days
Secondary outcomes (2)
Modified Rankin scale.
Functional disability. Modified rankin scale has 7 levels assigned 0 to 6. Low score suggest better outcome and high score means worse outcome
Measured: at 90 days
Fidelity of the device intervention.
Per protocol delivery of intervention. Total percentage of the intervention delivered over the study period will be calculated. We intend to deliver therapy for 7 days or up-to discharge after randomization. We will calculate the missing days and document reasons for the same. This will allow us to calculate the percentage of the therapy delivered.
Measured: at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start7 Jul 2022
- Primary completion1 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, Acute IschemicStudies 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
- Model description
- Prospective randomized control trial with blinded end-point. 1:2 randomization to sham or intervention arm. We will use sealed envelope randomization.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahesh Kate, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408130
- Sponsor's protocol ID
- Pro00117448
- Status last verified
- Aug 2024
- First submitted
- 25 May 2022
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be available to all interested investigators with main results of study.
Publications
Nair R, Sarmiento R, Sheriff A, Shuaib A, Buck B, Gauthier M, Mushahwar V, Ferguson-Pell M, Kate M. Assessment of remote ischemic conditioning delivery with optical sensor in acute ischemic stroke: Randomised clinical trial protocol. PLoS One. 2023 May 4;18(5):e0284879. doi: 10.1371/journal.pone.0284879. eCollection 2023.
PubMed 37141237Bhangoo G, Kashinkunti C, Sarmiento RJ, Khan N, Nair RK, Buck B, Gauthier M, Mushahwar V, Shuaib A, Ferguson-Pell M, Kate M. Monitoring of Remote Ischemic Conditioning with a Tissue Reflectance Sensor: A Randomized Control Trial. Cerebrovasc Dis. 2026 Oct 10:1. doi: 10.1159/ced/accag037. Online ahead of print.
PubMed 42858287
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning With Novel Optical Sensor Feedback Device in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05408130
- Acronym / sponsor ID
- Pro00117448
- Keywords
- remote ischemic conditioning, stroke, small vessel cerebrovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 7 Jun 2022 (actual)
- 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 a leading cause of physical and cognitive disabilities. The most common type of stroke is ischemic (lack of blood flow to the brain due to clot blocking a blood vessel). Many people with stroke (PwS) have changes on the brain imaging called small vessel disease (SVD). This is a condition that affects tiny blood vessels supplying the brain, leading to decreased blood flow in some parts of the brain. These brain changes may hamper the recovery process after stroke, or lead to recurrent stroke and cognitive impairment. SVD is a slow process that can be seen as multiple black spots on computed tomography or white spots on magnetic resonance imaging. Current treatments to reduce the effect of SVD on PwS are to control high blood pressure, high blood sugar, high cholesterol and increase physical activity. However, these approaches do not lead to a reduction in SVD.
Remote Ischemic Conditioning is a type of treatment delivered with help of a regular blood pressure machine. This does not involve any drug. A typical treatment involves the application of a blood pressure cuff followed by brief sessions of compressions and relaxation on the arm muscles much akin to blood pressure measurement but for 5 min. It leads to a transient safe state of less blood flow in arm muscles which initiates the release of molecules and signals transmitted by blood. These signals may then go on to improve blood flow in the brain. Recent animal and human studies have suggested that the use of RIC may reduce the SVD load.
A new device will be used to deliver remote ischemic conditioning therapy in a better manner. Existing devices generate the same amount of compression for all people. The pressure applied by the machine in the arm may be either more than required or less than required. The ideal compression would be one that achieves a low blood flow state in the arm at the least possible pressure. To achieve this our group is using a small light sensor to inform us. The light sensor is closely applied to the skin over the arm below the blood pressure cuff. It emits light that is absorbed by the skin and the light is then reflected. This is detected by other sensors placed together. From the reflected light the sensor can obtain information about blood flow in the skin. When the pressure increases with help of an automated machine the light sensor can detect that blood flow are reduced and this information is displayed on the computer. The information about skin blood flow will inform about the level of pressure to apply to give accurate treatment.
The new device with optical feedback will deliver RIC in PwS and SVD in a safe and reliable manner. A total of 51 patients will take part in this study. Thirty-four will get remote ischemic conditioning therapy and 17 patients will get sham-control therapy. All patients will get standard post-stroke treatment according to the Canadian Stroke Best Practices Recommendation.
Detailed description
- Hypothesis In patients with ischemic stroke and small vessel disease, Remote Ischemic Conditioning (RIC) delivered by novel device with optical feedback sensor will be safe and feasible.
- Rationale Cerebral small vessel disease (SVD) is highly prevalent in aging societies and also in patients with ischemic stroke.SVD is independently associated with cognitive impairment and incidence of stroke.SVD is characterised by presence of white matter lesions (commonly seen as hyperintensities on magnetic resonance imaging (MRI) or hypodensities on computed tomography, CT), microbleeds, prominent perivascular spaces, lacunar infarcts and intracerebral hemorrhages. Risk of worse outcomes in patients with ischemic stroke as assessed by modified Rankin scale (mRS) >2 is increased by odds ratio (OR) of 1.96 if there is a presence of white-matter hyperintensities (WMH). Furthermore, WMH are also associated with increased risk of recurrent stroke (OR 1.93), cognitive impairment (OR 2.22) and all-cause mortality (OR1.82). Current standard of care focuses on control of vascular risk factors including hypertension, diabetes, dyslipidemia, smoking, physical activity and mental health concerns to reduce the impact of WMH on stroke outcomes. There is no targeted therapy available for reducing the burden of SVD.
RIC involves brief cyclic ischemia (5 minutes, inflation of BP cuff) and reperfusion (5 minutes, deflation of BP cuff) of a distant organ (arm muscles) to protect at-risk (cerebral tissue) organ tissue by increasing ischemia tolerance. In experimental stroke RIC alone or in combination revascularization therapy may have additive effect, improve collateral circulation and reduce the infarct size.Human clinical trial in ischemic stroke have been promising so far. In animal models for vascular contributions to cognitive impairment and dementia (VCID) RIC for 1 month demonstrated improved cerebral blood flow, prevented white matter damage, improved angiogenesis and cognitive outcomes. In a pilot human study RIC for 1 year lead to reduction in WMH.
An important ongoing issue is the fidelity of RIC delivered to the patients. Typically for ischemia to develop in the limb muscles, current standard practice is to increase the pressure in the limb 30-50 mmHg above the systolic blood pressure to maximum of 200 mmHg. However, this may be variable in individual subjects. Pressure in upper limb may be associated with discomfort and consequent reduced compliance.An effective solution would be to identify ideal pressure target for each individual person. Our group is developing a novel RIC device, which will identify precise BP target with optical feedback sensor to deliver optimal ischemia with least possible pressure. This will improve patient experience and improve fidelity of RIC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized control trial with blinded end-point. 1:2 randomization to sham or intervention arm. We will use sealed envelope randomization.
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device | Experimental | Device: Remote Ischemic Conditioning with Novel Optical Sensor Feedback DeviceAll patients randomized to the intervention arm will receive 5 cycles of ischemia/reperfusion in the non-paralyzed upper limb or if no upper limb paralysis non-dominant arm. They will receive it once daily for a period of 7 days or during hospital stay whichever is shorter. |
| Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device | Sham comparator | Device: Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback DeviceIn the sham group subjects will receive pressure sensation by keeping the pressure at 30 mmHg for 3 min in both arms All patients in sham and intervention group will receive standard of care management for ischemic stroke. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with ischemic stroke (anterior and posterior circulation involvement) with or without neurological deficit within 48h of symptom onset
- CT head or MRI Brain evidence of infarct
- CT head or MRI Brain evidence of moderate or severe small vessel disease. We will assess atrophy, leukoaraiosis and old vascular lesions.
- Premorbid functional disability assessed by mRS <2
- National institute of Health Stroke scale <15 at the time of enrollment
Key exclusion criteria (8 listed)
- Patient is part of other clinical trial delivering intervention
- Injury to the upper arm or any other musculoskeletal disability/pain precluding from tolerating RIC therapy
- Treatment of ongoing malignancy with expected survival < 6 months
- Presence of hypertensive urgency and emergency
- Presence of hemodynamic instability
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 |
|---|---|---|
| Remote Ischemic Conditioning with Novel Optical Sensor Feedback DeviceAll patients randomized to intervention arm will receive 5 cycles of ischemia/reperfusion in non-paralysed upper limb or if no upper limb paralysis non-dominant arm. They will receive it once daily for a period of 7 days or during hospital stay whichever is shorter. | Device | Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device |
| Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback DeviceIn the sham group subjects will receive pressure sensation by keeping the pressure at 30 mmHg for 3 min in both arms All patients in sham and intervention group will receive standard of care management for ischemic stroke | Device | Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device |
Primary outcome
Likert scale
Time frame: at 7 days
The primary outcome measure is the safety and feasibility of RIC delivered during the first 7 days or at the time of discharge. In safety, we will assess the level of comfort with the Likert scale. The Likert scale will be divided into 5 levels very comfortable, comfortable, neither comfortable nor uncomfortable, uncomfortable and very uncomfortable. In safety, we would assess pain or any persistent bruises.
2 secondary outcomes
Modified Rankin scale.
Time frame: at 90 days
Fidelity of the device intervention.
Time frame: at 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Background: PubMed 37141237Nair R, Sarmiento R, Sheriff A, Shuaib A, Buck B, Gauthier M, Mushahwar V, Ferguson-Pell M, Kate M. Assessment of remote ischemic conditioning delivery with optical sensor in acute ischemic stroke: Randomised clinical trial protocol. PLoS One. 2023 May 4;18(5):e0284879. doi: 10.1371/journal.pone.0284879. eCollection 2023.
- Derived from this study: PubMed 42858287Bhangoo G, Kashinkunti C, Sarmiento RJ, Khan N, Nair RK, Buck B, Gauthier M, Mushahwar V, Shuaib A, Ferguson-Pell M, Kate M. Monitoring of Remote Ischemic Conditioning with a Tissue Reflectance Sensor: A Randomized Control Trial. Cerebrovasc Dis. 2026 Oct 10:1. doi: 10.1159/ced/accag037. Online ahead of print.
- Individual participant dataSharing planned: Yes. Study data will be available to all interested investigators with main results of study.
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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.
Mahesh Kate principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device in people with Stroke, Acute Ischemic and Small Vessel Cerebrovascular Disease, run by University of Alberta at 1 site in Canada.
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 8 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: finished, as of the sponsor's last update on 28 Aug 2024. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Likert scale (time frame: at 7 days). 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 NCT05408130, which also lists 2 linked publications.
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 28 Aug 2024.