Age-related Cerebral White Matter Changes, Cognition Disorder
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICEremote ischemic conditioning
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
Sponsors
Georgia Rehabilitation Institute
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
concealed allocations and blinded laboratory personnel.
Intervention model description
randomized
Eligibility
Sex/Gender
ALL
Age
56 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RBC deformability index | 5 weeks total study duration | from baseline to 4 weeks of treatment and one week off treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inflammatory and anti-inflammatory Interleukins | 5 weeks | ability to tolerate and adhere to protocol treatments. |
| tolerability | 4 weeks | any discontinuation and adverse events during treatment. |
Countries
United States
Contacts
Primary ContactAskiel Bruno, MD
Outcome results
None listed