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NCT Number: NCT06911385

Augmenting Cerebral Blood Flow in Acute Ischemic Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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)

Primary outcomes

  1. Feasibility of intervention completion

    Time frame: End of intervention at 1 hour

    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.

Secondary outcomes

  1. Tolerability of intervention

    Time frame: End of intervention at 1 hour

    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).

  2. Change in cortical oxygenation content

    Time frame: End of intervention at 1 hour

    The secondary physiological outcome measure is change in cortical oxygenation content as assessed by continuous wave-fNIRS before and after treatment.

  3. Feasibility of ease of delivery of the intervention

    Time frame: End of intervention at 1 hour

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuella Osuji, PMP, MSc

CONTACT

[email protected]

780-492-4137

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 4, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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