To check the feasibility of a novel Remote Ischemic Conditioning (RIC) device.

RIC therapy is delivered by increasing the pressure in the arm cuff 50 mmHg above systolic BP to a maximum of 200 mmHg. This may be associated with discomfort and consequently reduced compliance with RIC therapy. Our group has developed a novel RIC device, with an optical skin perfusion sensor to assess distal limb ischemia during RIC therapy.

This is a prospective, single-center, randomized control trial for the feasibility of the device. Patients of acute ischemic stroke with moderate to severe small vessel disease are randomized 2:1 to intervention vs sham control arms for a period of 7 days or until discharge. All patients randomized to the intervention arm will receive 5 cycles of ischemia/ reperfusion in a non-paralyzed arm. Patients in the sham control arm will receive pressure sensation by keeping the cuff pressure at 30 mmHg for 5 minutes for 5 cycles.

We have enrolled a total of 10 (7 Intervention arm and 3 Sham Control) patients to date at a median(IQR) 71.5 (79.5) hours after symptom onset, with mean±SD age of 68.6±9years and median (IQR) NIHSS of 5(8). We found no differences in oxygenated hemoglobin and hemoglobin concentration with either 30 or 50 mmHg systolic BP increase in the arm cuff in the intervention group. The procedure-related comfort measured by the Likert scale showed a median(IQR) of 3.00(1, neither comfortable nor uncomfortable) in the intervention arm and 1.50(1, very comfortable) in the sham control arm. No safety concerns were noted in the intervention or sham arm.

RIC with the skin perfusion sensor assessment is feasible. There were no safety concerns.

Clinical Trial Registration Number: clinicaltrials.gov NCT05408130