Remote Ischemic Conditioning With Novel Optical Sensor Feedback Device in Acute Ischemic Stroke

NCT05408130 | Completed DMC

• 1 other identifier: Pro00117448
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a leading cause of physical and cognitive disabilities. The most common type of stroke is ischemic (lack of blood flow to the brain due to clot blocking a blood vessel). Many people with stroke (PwS) have changes on the brain imaging called small vessel disease (SVD). This is a condition that affects tiny blood vessels supplying the brain, leading to decreased blood flow in some parts of the brain. These brain changes may hamper the recovery process after stroke, or lead to recurrent stroke and cognitive impairment. SVD is a slow process that can be seen as multiple black spots on computed tomography or white spots on magnetic resonance imaging. Current treatments to reduce the effect of SVD on PwS are to control high blood pressure, high blood sugar, high cholesterol and increase physical activity. However, these approaches do not lead to a reduction in SVD. Remote Ischemic Conditioning is a type of treatment delivered with 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. Recent animal and human studies have suggested that the use of RIC may reduce the SVD load. A new device will be used to deliver remote ischemic conditioning therapy in a better manner. Existing devices generate the same amount of compression for all people. The pressure applied by the machine in the arm may be either more than required or less than required. The ideal compression would be one that achieves a low blood flow state in the arm at the least possible pressure. To achieve this our group is using a small light sensor to inform us. The light sensor is closely applied to the skin over the arm below the blood pressure cuff. It emits light that is absorbed by the skin and the light is then reflected. This is detected by other sensors placed together. From the reflected light the sensor can obtain information about blood flow in the skin. When the pressure increases with help of an automated machine the light sensor can detect that blood flow are reduced and this information is displayed on the computer. The information about skin blood flow will inform about the level of pressure to apply to give accurate treatment. The new device with optical feedback will deliver RIC in PwS and SVD in a safe and reliable manner. A total of 51 patients will take part in this study. Thirty-four will get remote ischemic conditioning therapy and 17 patients will get sham-control therapy. All patients will get standard post-stroke treatment according to the Canadian Stroke Best Practices Recommendation.

Conditions

Stroke, Acute Ischemic; Small Vessel Cerebrovascular Disease

Keywords

remote ischemic conditioning; stroke; small vessel cerebrovascular disease

Outcome Measures

Primary Outcomes (1)

• Likert scale

  The primary outcome measure is the safety and feasibility of RIC delivered during the first 7 days or at the time of discharge. In safety, we will assess the level of comfort with the Likert scale. The Likert scale will be divided into 5 levels very comfortable, comfortable, neither comfortable nor uncomfortable, uncomfortable and very uncomfortable. In safety, we would assess pain or any persistent bruises.

  at 7 days

Secondary Outcomes (2)

• Modified Rankin scale.

  at 90 days

• Fidelity of the device intervention.

  at 7 days

Study Arms (2)

Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device

EXPERIMENTAL

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.

Device: Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device

Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device

SHAM COMPARATOR

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.

Device: Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device

Interventions

Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device DEVICE

All patients randomized to intervention arm will receive 5 cycles of ischemia/reperfusion in non-paralysed 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.

Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device

Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device DEVICE

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

Sham Remote Ischemic Conditioning with Novel Optical Sensor Feedback Device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with ischemic stroke (anterior and posterior circulation involvement) with or without neurological deficit within 48h of symptom onset
• CT head or MRI Brain evidence of infarct
• CT head or MRI Brain evidence of moderate or severe small vessel disease. We will assess atrophy, leukoaraiosis and old vascular lesions.
• Premorbid functional disability assessed by mRS \<2
• National institute of Health Stroke scale \<15 at the time of enrollment

You may not qualify if:

• Patient is part of other clinical trial delivering intervention
• Injury to the upper arm or any other musculoskeletal disability/pain precluding from tolerating RIC therapy
• Treatment of ongoing malignancy with expected survival \< 6 months
• Presence of hypertensive urgency and emergency
• Presence of hemodynamic instability
• Presence of ongoing systemic infection with antibiotic therapy
• Pregnant and lactating women
• History of dermatological conditions affecting application of tissue perfusion sensor and remote ischemic conditioning pressure cuff

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (1)

• Nair R, Sarmiento R, Sheriff A, Shuaib A, Buck B, Gauthier M, Mushahwar V, Ferguson-Pell M, Kate M. Assessment of remote ischemic conditioning delivery with optical sensor in acute ischemic stroke: Randomised clinical trial protocol. PLoS One. 2023 May 4;18(5):e0284879. doi: 10.1371/journal.pone.0284879. eCollection 2023.

  PMID: 37141237 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Small Vessel Diseases; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Mahesh Kate

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized control trial with blinded end-point. 1:2 randomization to sham or intervention arm. We will use sealed envelope randomization.

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 7, 2022
• Study Start: July 7, 2022
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will be available 6 months after study completion
• Access Criteria: Please contact the principal investigator

Locations

CA (1)