Recruiting

Remote Ischemic Conditioning

Sponsor:

Augusta University

Code:

NCT06179797

Conditions

Age-related Cerebral White Matter Changes

Cognition Disorder

Eligibility Criteria

Sex: All

Age: 56+

Healthy Volunteers: Not accepted

Interventions

remote ischemic conditioning

Study Details

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.

Conditions

Age-related Cerebral White Matter Changes

Cognition Disorder

Study ID

NCT06179797

Start date

Aug 15, 2020

Status verified date

Dec, 2023

Completion date

Dec 15, 2023

Anticipated

Primary completion date

Dec 15, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 56+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: sham

BP cuff bilateral arm compression to 50 mmHg.

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.

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.

active comparator: dose 3

BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off once daily.

active comparator: dose 4

BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off twice daily.

Interventions

remote ischemic conditioning

suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.

Primary outcome measure

  • RBC deformability index [ Time Frame: 5 weeks total study duration ]

Central Contacts and Locations

Central contacts

Askiel Bruno, MD

706-721-1691abruno@augusta.edu

Locations

Wellstar MCG Health

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Askiel Bruno, MD

706-721-1691abruno@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Dec 22, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2023-12-22.