Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device for Blood Vessel

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alberta Hospital, Edmonton, Canada
Blood Vessel+8 More
Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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). 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.

Eligible Conditions

  • Blood Vessel
  • Cerebrovascular accident

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: at 90 days

at 7 days
Fidelity of the device intervention.
Likert scale
at 90 days
Modified Rankin scale.

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device
1 of 2
Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device
1 of 2
Experimental Treatment
Non-Treatment Group

51 Total Participants · 2 Treatment Groups

Primary Treatment: Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device · Has Placebo Group · N/A

Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device
Device
Experimental Group · 1 Intervention: Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device · Intervention Types: Device
Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device
Device
ShamComparator Group · 1 Intervention: Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 90 days
Closest Location: University of Alberta Hospital · Edmonton, Canada
Photo of university of alberta hospital 1Photo of university of alberta hospital 2Photo of university of alberta hospital 3
2009First Recorded Clinical Trial
0 TrialsResearching Blood Vessel
277 CompletedClinical Trials

Who is running the clinical trial?

University of AlbertaLead Sponsor
797 Previous Clinical Trials
368,765 Total Patients Enrolled
Mahesh KatePrincipal InvestigatorUniversity of Alberta

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have evidence of a brain infarct on CT or MRI.
You have a premorbid mRS score of <2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.