NCT05408130

Remote Ischemic Conditioning With Novel Optical Sensor Feedback Device in Acute Ischemic Stroke

Completed NA Last updated 28 August 2024

What this trial tests

NA trial testing Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device in Stroke, Acute Ischemic in 51 participants. Completed in 1 August 2024.

Timeline

7 July 2022

Primary endpoint
1 June 2024

1 August 2024

Quick facts

Lead sponsor	University of Alberta
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	51
Start date	7 July 2022
Primary completion	1 June 2024
Estimated completion	1 August 2024
Sites	1 location across Canada

Drugs / interventions tested

• Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device
• Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device

Conditions studied

• Stroke, Acute Ischemic — all drugs for Stroke, Acute Ischemic →
• Small Vessel Cerebrovascular Disease — all drugs for Small Vessel Cerebrovascular Disease →

Sponsor

University of Alberta

Who can join

Adults 18 to 100, any sex, with Stroke, Acute Ischemic or Small Vessel Cerebrovascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Assessment of remote ischemic conditioning delivery with optical sensor in acute ischemic stroke: Randomised clinical trial protocol.
   Nair R, Sarmiento R, Sheriff A, Shuaib A, et al · · 2023 · cited 1× · PMID 37141237 · DOI 10.1371/journal.pone.0284879