Trial of Remote Ischemic Pre-conditioning in Vascular Cognitive Impairment (TRIC-VCI)
Vascular Dementia, Cerebral Small Vessel Diseases, Cerebral Small Vessel Ischaemic Disease
About this trial
This is an interventional treatment trial for Vascular Dementia focused on measuring vascular cognitive impairment, cerebral small vessel diseases, remote ischemic conditioning
Eligibility Criteria
Inclusion Criteria:
- Evidence of cerebral small vessel disease on CT or MRI, defined as either beginning confluent white matter hypodensities/hyperintensities (ARWMC scale) or two or more supratentorial infarcts
- Montreal Cognitive Assessment <25
- Concern on the part of the patient, caregiver, or clinician that there has been a decline from previous level of cognitive functioning
- Independent with basic activities of daily living (response (a) to questions 2, 4, 5, 6, 7, 8, 9, and 14 on the Bristol Activities of Daily Living scale).
Exclusion Criteria:
- Cortical infarcts larger than 10 mm axial diameter
- Neuroimaging evidence of mass lesion, intracerebral hemorrhage, vascular malformation, or evidence of non-vascular disease such as hydrocephalus.
- Residence in long-term care facility.
- Other significant neurological or psychiatric disease (e.g. multiple sclerosis).
- Does not have a study partner who can provide corroborative information.
- English or French is not sufficiently proficient for clinical assessment and neuropsychological testing
- Montreal Cognitive Assessment score <13
- Unable to undergo MRI due to medical contraindications or inability to tolerate the procedure.
- Co-morbid medical illness that in the judgment of the study investigator makes it unlikely that the participant will be able to complete three months of study follow-up.
- On therapeutic anticoagulation with doses used for treatment of deep venous thrombosis, pulmonary embolism, or for stroke prevention in atrial fibrillation.
- Significant bleeding diathesis.
- Any symptomatic or previously known arm soft-tissue disease, vascular injury, or peripheral vascular disease
- Hypertension with systolic blood pressure >=180 mmHg despite medical treatment at the time of enrolment.
- Planned revascularization (any angioplasty or vascular surgery) within the next 3 months.
- Planned surgical procedure within the next 3 months.
- Currently receiving an investigational drug or device by other studies
- Blood pressure cuff cannot be sized properly (arm circumference is <23 cm or >42 cm)
Sites / Locations
- Foothills Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
RIC once per day
RIC twice per day
RIC performed once a day on one arm. Each RIC session will consist of 4 cycles of unilateral or simultaneous bilateral upper arm ischemia for 5 minutes followed by reperfusion for another 5 minutes. The procedure will be performed by using an electric auto-control device with cuffs that inflate to a pressure of 200 mmHg during the ischemic period.
RIC performed twice a day on one arm, approximately 12 hours apart. Each RIC session will consist of 4 cycles of unilateral or simultaneous bilateral upper arm ischemia for 5 minutes followed by reperfusion for another 5 minutes. The procedure will be performed by using an electric auto-control device with cuffs that inflate to a pressure of 200 mmHg during the ischemic period.