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Remote Ischemic Conditioning for Stroke
N/A
Recruiting
Led By Mahesh Kate
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Premorbid functional disability assessed by mRS <2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 90 days
Awards & highlights
Study Summary
This trial will test whether a new device that uses optical feedback to deliver remote ischemic conditioning therapy is safe and feasible in people who have had a stroke.
Who is the study for?
This trial is for adults who've had an ischemic stroke within the last 48 hours, have moderate to severe small vessel disease evident on brain scans, and are generally functional (mRS <2). They must not be pregnant, in another clinical trial, or have conditions that prevent RIC therapy like skin issues or arm injuries.Check my eligibility
What is being tested?
The study tests a new device delivering Remote Ischemic Conditioning (RIC) using optical sensors to optimize blood flow restriction. It compares this method against a sham procedure in patients with ischemic stroke and small vessel disease alongside standard post-stroke care.See study design
What are the potential side effects?
Since RIC doesn't involve drugs but uses a blood pressure cuff-like device on the arm, side effects may include discomfort or bruising at the cuff site. The treatment is non-invasive so more serious side effects are unlikely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was independent in daily activities before my current illness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Likert scale
Secondary outcome measures
Fidelity of the device intervention.
Modified Rankin scale.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Remote Ischemic Conditioning with Novel Optical Sensor Feedback DeviceExperimental Treatment1 Intervention
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.
Group II: Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback DevicePlacebo Group1 Intervention
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.
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Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,083 Total Patients Enrolled
Mahesh KatePrincipal InvestigatorUniversity of Alberta
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your stroke severity score is less than 15 when you join the study.I have unstable blood pressure or heart issues.You have evidence of moderate or severe small vessel disease in your brain, as seen in a CT scan or MRI.I have experienced severe hypertension crises.I was independent in daily activities before my current illness.I had a stroke affecting any part of my brain within the last 2 days.I have an injury or disability in my upper arm that prevents me from undergoing certain therapies.I am currently on antibiotics for an infection.You have evidence of a stroke in your brain on a CT scan or MRI.I have skin conditions that may interfere with medical device use on my skin.My doctor expects I have less than 6 months to live due to my cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device
- Group 2: Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial accept individuals over the age of 70?
"This clinical trial's terms of eligibility state that potential participants must be aged 18 or above, yet no older than 100."
Answered by AI
Is enrollment for this trial currently open?
"Per the latest update on clinicaltrials.gov, this medical research is presently searching for members to take part in the experiment that was initially posted on July 7th 2022. The most recent modification occurred on July 19th 2022."
Answered by AI
How many individuals are presently engaged in this experiment?
"Affirmative. Data accessible on clinicaltrials.gov enumerates that this trial is currently enrolling participants, with the initial post being made in July 7th 2022 and most recently updated on 19th of the same month. 51 volunteers are required to be gathered from a single location for this study."
Answered by AI
To whom is participation in this research open?
"To be considered for eligibility, applicants must possess a healthy vascular system and fall between the ages of 18-100. 51 participants are being recruited in total."
Answered by AI
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