Chronic Remote Ischemic Conditioning in Vascular Cognitive Impairment: A Dose Escalation Study
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Askiel Bruno, MD
- Phone Number: 706-721-1691
- Email: abruno@augusta.edu
Study Locations
-
-
Georgia
-
Augusta, Georgia, United States, 30912
- Recruiting
- Wellstar MCG Health
-
Contact:
- Askiel Bruno, MD
- Phone Number: 706-721-1691
- Email: abruno@augusta.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥55 years
- Head MRI in the past 6 months showing no more than moderate age related cerebral white matter changes (Fazekas score 0-2).
- Able to walk without assistance & independently perform basic activities of daily living.
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: sham
BP cuff bilateral arm compression to 50 mmHg.
|
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
Other Names:
|
|
Active Comparator: dose 1
BP cuff bilateral arm compression to 50 mmHg above systolic BP for 2.5 minutes on/off for 4 cycles every other day.
|
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
Other Names:
|
|
Active Comparator: dose 2
BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off for 4 cycles every other day.
|
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
Other Names:
|
|
Active Comparator: dose 3
BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off once daily.
|
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
Other Names:
|
|
Active Comparator: dose 4
BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off twice daily.
|
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RBC deformability index
Time Frame: 5 weeks total study duration
|
from baseline to 4 weeks of treatment and one week off treatment
|
5 weeks total study duration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
inflammatory and anti-inflammatory Interleukins
Time Frame: 5 weeks
|
ability to tolerate and adhere to protocol treatments.
|
5 weeks
|
|
tolerability
Time Frame: 4 weeks
|
any discontinuation and adverse events during treatment.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Carol Smith, RN, Wellstar MCG Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1513705-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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