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

Not Applicable

Recruiting

• Conditions: Cognition Disorder; Age-related Cerebral White Matter Changes
• Interventions: Device: remote ischemic conditioning

• Registration Number: NCT06179797
• Lead Sponsor: Augusta University

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.

Study Timeline

• Study Start: 2020-08-15
• Status Verified: 2023-12
• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Study First Posted: 2023-12-22
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dose 4	remote ischemic conditioning	BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off twice daily.
sham	remote ischemic conditioning	BP cuff bilateral arm compression to 50 mmHg.
dose 1	remote ischemic conditioning	BP cuff bilateral arm compression to 50 mmHg above systolic BP for 2.5 minutes on/off for 4 cycles every other day.
dose 3	remote ischemic conditioning	BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off once daily.
dose 2	remote ischemic conditioning	BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off for 4 cycles every other day.

Primary Outcome Measures

Name	Time	Method
RBC deformability index	5 weeks total study duration	from baseline to 4 weeks of treatment and one week off treatment

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Wellstar MCG Health; 🇺🇸 Augusta, Georgia, United States