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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
Wellstar MCG Health
Augusta, Georgia, United States
RECRUITINGRBC deformability index
from baseline to 4 weeks of treatment and one week off treatment
Time frame: 5 weeks total study duration
inflammatory and anti-inflammatory Interleukins
ability to tolerate and adhere to protocol treatments.
Time frame: 5 weeks
tolerability
any discontinuation and adverse events during treatment.
Time frame: 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.