Augmenting Cerebral Blood Flow in Acute Ischemic Stroke

NCT06911385 | Not Yet Recruiting Phase 1

• 2 other identifiers: Pro00139595RES0060767
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke

Keywords

Remote ischemic conditioning; Pneumatic Lower limb Compression; Stroke; Cerebral blood flow; Functional near infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Tolerability of intervention

  End of intervention at 1 hour

• Change in cortical oxygenation content

  End of intervention at 1 hour

• Feasibility of ease of delivery of the intervention

  End of intervention at 1 hour

Study Arms (1)

Remote ischemic conditioning plus Pneumatic Compression

EXPERIMENTAL

Device: Arm Remote Ischemic Conditioning plus Pneumatic Compression lower limb

Interventions

Arm Remote Ischemic Conditioning plus Pneumatic Compression lower limb DEVICE

Arm Remote Ischemic Conditioning (4 cycles) plus Pneumatic Compression lower limb (100 mmHg for 1 hour)

Remote ischemic conditioning plus Pneumatic Compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• History of dermatological conditions affecting application of RIC cuff with tissue perfusion sensor and pneumatic compression boots.
• History of peripheral arterial disease
• Treatment of ongoing malignancy with expected survival \< 6 months
• Presence of hypertensive urgency and emergency
• Presence of hemodynamic instability and ongoing pulmonary edema
• Presence of clinical or imaging signs of raised intracranial, intrathoracic, and /or intra-abdominal pressure.
• Presence of ongoing systemic infection with antibiotic therapy
• Pregnant and lactating women
• Participant not part of other clinical intervention trial

Sponsors & Collaborators

• University of Alberta: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mahesh Kate, MD, DM

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuella Osuji, PMP, MSc

CONTACT

780-492-4137; osuji@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months after completion of study
• Access Criteria: Please contact the principal investigator