Augmenting Cerebral Blood Flow in Acute Ischemic Stroke

Augmenting Cerebral Blood Flow Using a Novel Combined Treatment Approach in Patients With Ischemic Stroke: Protocol Development

The most common type of stroke is ischemic (lack of blood flow to the brain due to a clot blocking a blood vessel). Time is brain and an average of 1.9 million brain nerve cells per minute are destroyed in patients experiencing a typical LVO. The main goal of treatment is to help restore blood flow as quickly as possible and prevent brain tissue and cell death. Acute treatments like clot-busting medication or clot removal by wire are standard of care but are available in comprehensive stroke centers in a few urban centers. Often, patients need to be transferred to these centers via ground or air ambulance, sometimes over hours, and no active treatment can be provided during these transfers.

Enhancing or increasing blood flow to the brain is associated with good outcomes in stroke. This study involves an innovative approach combining two treatment interventions - Remote ischemic conditioning (arms) and Air compression therapy (legs, applied simultaneously to all four limbs, that may help improve blood flow to the brain. Remote Ischemic Conditioning is a type of treatment delivered with the 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. Air Compression is delivered by a commercially available device (Normatech Elite). They are inflatable sleeves resembling puffy thigh-high boots that deliver compressive pulses stimulating blood flow in the legs, in a graded manner from the ankles to the thighs. We believe this air compression device may help improve and divert blood flow to stroke-affected areas in the brain.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Arm Remote Ischemic Conditioning plus Pneumatic Compression lower limb

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Emmanuella Osuji, PMP, MSc; Phone Number: 780-492-4137; Email: osuji@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age > 18 years
2. Both male and female participants will be included
3. History of Stroke Symptoms
4. Baseline modified Rankin scale score < 2
5. Participant or substitute decision-maker able to provide informed consent.

Exclusion Criteria:

1. Injury to the upper arms, lower limbs (from ankles to thighs), or any other musculoskeletal disability/pain that precludes tolerating RIC and/or Pneumatic compression therapy.
2. History of dermatological conditions affecting application of RIC cuff with tissue perfusion sensor and pneumatic compression boots.
3. History of peripheral arterial disease
4. Treatment of ongoing malignancy with expected survival < 6 months
5. Presence of hypertensive urgency and emergency
6. Presence of hemodynamic instability and ongoing pulmonary edema
7. Presence of clinical or imaging signs of raised intracranial, intrathoracic, and /or intra-abdominal pressure.
8. Presence of ongoing systemic infection with antibiotic therapy
9. Pregnant and lactating women
10. Participant not part of other clinical intervention trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote ischemic conditioning plus Pneumatic Compression	Device: Arm Remote Ischemic Conditioning plus Pneumatic Compression lower limb; Arm Remote Ischemic Conditioning (4 cycles) plus Pneumatic Compression lower limb (100 mmHg for 1 hour)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of intervention completion	The primary outcome measure is the feasibility of intervention completion as assessed by proportion of patients able to complete the treatment protocol including pre-treatment assessment, intervention, and post-treatment assessment.	End of intervention at 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of intervention	The secondary outcome measure is tolerability of intervention as assessed by the 5-point Likert scale (1 Very comfortable, 2 Comfortable, 3 neither comfortable nor uncomfortable, 4 uncomfortable, 5 very uncomfortable).	End of intervention at 1 hour
Change in cortical oxygenation content	The secondary physiological outcome measure is change in cortical oxygenation content as assessed by continuous wave-fNIRS before and after treatment.	End of intervention at 1 hour
Feasibility of ease of delivery of the intervention	The secondary feasibility outcome measure is ease of delivery of the intervention individual patients by study team member as assessed by 5-point Likert scale (1-very easy, 2-easy, 3-neither easy nor difficult, 4-difficult and 5-very difficult).	End of intervention at 1 hour

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Mahesh Kate, MD, DM, University of Alberta

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Cerebral blood flow; Remote ischemic conditioning; Functional near infrared spectroscopy; Pneumatic Lower limb Compression
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: Pro00139595; RES0060767 (Other Grant/Funding Number: Health Everywhere: Building an ecosystem of innovation in eHealth and mHealth in Alberta)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 6 months after completion of study
• IPD Sharing Access Criteria: Please contact the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No