Chronic Remote Ischemic Conditioning in Vascular Cognitive Impairment: A Dose Escalation Study

Augusta University

Status: Enrolling

Conditions: Cognition Disorder; Age-related Cerebral White Matter Changes

Treatments: Device: remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT06179797

1513705-3

Details and patient eligibility

About

To evaluate the dose-response of relevant blood biomarkers to remote ischemic conditioning in patients with age-related cerebral white matter hyperintensities on MRI, in preparation for a subsequent larger efficacy trial.

Full description

Objective: The objective of this early phase study is to evaluate the dose-response of relevant blood biomarkers to remote ischemic conditioning in preparation for a subsequent larger efficacy trial. In addition, we will evaluate the tolerability and adherence to the treatment protocol.

Aim: We aim to measure blood biomarkers in response to daily remote ischemic conditioning (RIC) using a dose escalation study design in 40 patients with age-related cerebral white matter hyperintensities on MRI.

Hypothesis: We hypothesize that there will be a significant change in the biomarker levels in a dose dependent fashion.

Enrollment: 40 estimated patients

Sex: All

Ages: 56+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥55 years
2. Head MRI in the past 6 months showing no more than moderate age related cerebral white matter changes (Fazekas score 0-2).
3. Able to walk without assistance & independently perform basic activities of daily living.
4. Able to understand this study and agree for a valid consent.

Exclusion criteria

Prior non-lacunar (cortical) stroke. 2. Unable to cooperate with the use of the conditioning device. 3. Confounding illness that might interfere with the interpretation of results (such as active malignancy or multiple sclerosis).

4. Contraindication to transient arm ischemia in either arm (such as symptomatic peripheral artery disease).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups

sham

Sham Comparator group

Description:

BP cuff bilateral arm compression to 50 mmHg.

Treatment:

Device: remote ischemic conditioning

dose 1

Active Comparator group

Description:

BP cuff bilateral arm compression to 50 mmHg above systolic BP for 2.5 minutes on/off for 4 cycles every other day.

Treatment:

Device: remote ischemic conditioning

dose 2

Active Comparator group

Description:

BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off for 4 cycles every other day.

Treatment:

Device: remote ischemic conditioning

dose 3

Active Comparator group

Description:

BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off once daily.

Treatment:

Device: remote ischemic conditioning

dose 4

Active Comparator group

Description:

BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off twice daily.

Treatment:

Device: remote ischemic conditioning