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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognition Disorder; Age-related Cerebral White Matter Changes
• Intervention / Treatment: Device: remote ischemic conditioning

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: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Askiel Bruno, MD; Phone Number: 706-721-1691; Email: abruno@augusta.edu

Study Locations

• United States
  • 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: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham; BP cuff bilateral arm compression to 50 mmHg.	Device: remote ischemic conditioning; suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.; Other Names: RIC
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.	Device: remote ischemic conditioning; suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.; Other Names: RIC
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.	Device: remote ischemic conditioning; suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.; Other Names: RIC
Active Comparator: dose 3; BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off once daily.	Device: remote ischemic conditioning; suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.; Other Names: RIC
Active Comparator: dose 4; BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off twice daily.	Device: remote ischemic conditioning; suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.; Other Names: RIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RBC deformability index	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	ability to tolerate and adhere to protocol treatments.	5 weeks
tolerability	any discontinuation and adverse events during treatment.	4 weeks

Collaborators and Investigators

• Sponsor: Augusta University
• Collaborators: Georgia Rehabilitation Institute
• Investigators: Study Director: Carol Smith, RN, Wellstar MCG Health

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognitive Dysfunction; Cognition Disorders
• Other Study ID Numbers: 1513705-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: yes, upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No