Testing of a System for Remote Ischemic Conditioning in Cerebral Small Vessel Disease and Pre-hospital Stroke Care
This early study is looking into a new device that aims to protect the brain. It uses a method called Remote Ischemic Conditioning (RIC), which involves gently squeezing and releasing an arm with a special cuff. This technique might help people with small vessel disease in the brain (a condition that can lead to memory problems and strokes) or those who have just had a stroke. The main goals are to check if the device is safe and easy for patients and healthcare workers to use. About 24 people with small vessel disease will use the device daily for 60 days, and a few stroke patients and paramedics will also test it. This research could lead to new ways to protect the brain and improve stroke care in the future.
At a glance
What is this study about?
This study explores a new way to help protect the brain using a technique called Remote Ischemic Conditioning (RIC). Imagine a special cuff, similar to a blood pressure cuff, that gently squeezes and then releases your arm. This process, repeated a few times, sends signals that might protect your brain from damage, for example, after a stroke or in a condition called Cerebral Small Vessel Disease.
Cerebral Small Vessel Disease is a common condition where tiny blood vessels in the brain are damaged. This can lead to small strokes and problems with memory and thinking. Currently, there aren't many treatments for this. Also, when someone has a stroke, getting treatment quickly is vital. However, for many, especially in big countries like Canada with long distances, getting to a hospital in time can be a challenge. We need new ways to protect the brain during this crucial period before hospital treatment can begin.
This early study, called a Phase 2 trial, aims to test a new device designed to deliver RIC. We want to see if it’s safe, if people can use it easily, and if it makes them feel comfortable. If successful, this research could pave the way for new treatments to help people with brain conditions and improve stroke care, potentially even before they reach the hospital.
Key takeaways
- This is an early study testing a new device for brain protection.
- The device uses a cuff on the arm, similar to a blood pressure cuff.
- It aims to help people with small vessel disease in the brain and stroke patients.
- The main goals are to check device safety and ease of use.
- Participation involves using the device daily for 60 days for some participants.
- It's exploring new ways to improve brain health and stroke care.
Who may be eligible?
To join this study, you would need to be at least 18 years old. There are two main groups of people being sought for the study.
One group is for people living with Cerebral Small Vessel Disease. To be eligible, you would need to show signs of this condition on your brain scans and either have concerns about your memory or thinking, or have had a small vessel stroke confirmed by your doctor. You also need to be able to talk and communicate clearly, and have a phone for us to check in with you. If you take certain blood-thinning medications or have specific issues with your arm (like a blocked artery or injury), you might not be able to participate.
Another very small group is for people who have just had a stroke and are being treated in a special 'mobile stroke unit' (a special ambulance fully equipped to treat strokes). Similar to the other group, you would need to be at least 18 years old. If you cannot give consent due to your stroke, or if you are on strong blood thinners or have an arm injury, this part of the study might not be suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have signs of Cerebral Small Vessel Disease on your brain scans and concerns about your memory, or a history of small vessel stroke?
- Can you speak and communicate clearly?
- Do you have access to a phone for study check-ins?
- Do you have any arm injuries or specific circulation problems that might prevent you from using an arm cuff?
What does participation involve?
If you take part in the study for Cerebral Small Vessel Disease, you will use the RIC device at home every day for 60 days. Each day, you'll have brief sessions with the device. For the first 30 days, you will either receive the actual RIC therapy or a 'dummy' treatment (sham control). After 30 days, those who received the dummy treatment will switch to the actual RIC therapy for the remaining 30 days. You will be asked to provide feedback on using the device. The study team will monitor you during this time. The total duration of your active participation will be 60 days.
For those involved in the mobile stroke unit part of the study, the device will be tested on you if you have an acute stroke. This will be a short-term assessment. Additionally, about 10 stroke doctors and paramedics will also use the device and provide feedback on how easy it is to operate.
Potential risks and benefits
Locations (1)
- Foothills Medical CentreVerified postcodeCalgary, Canada
Common questions
What is Remote Ischemic Conditioning (RIC)?
It's a treatment idea where a special cuff, like a blood pressure cuff, briefly squeezes and releases your arm. This is thought to send signals that protect other parts of your body, like your brain.
What is Cerebral Small Vessel Disease?
It's a common condition where tiny blood vessels in the brain are damaged. This can lead to small strokes and affect memory and thinking abilities.
Will I definitely get the active treatment?
If you're in the Cerebral Small Vessel Disease group, you'll be randomly assigned to either active treatment or a 'dummy' treatment for the first 30 days. However, everyone will receive the active treatment for the final 30 days.
How long will I be involved in the study?
If you have Cerebral Small Vessel Disease, you'll use the device daily for 60 days and provide feedback. For stroke patients in the mobile unit, participation will be during your acute care.
What are the main goals of this study?
The study aims to see if the device is safe, easy to use, and how well it works for protecting the brain in people with Cerebral Small Vessel Disease or who have had a stroke.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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