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

Cognition Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179797
• Other study ID #: 1513705-3
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: December 15, 2023

Study information

• Verified date: December 2023
• Source: Augusta University
• Contact: Askiel Bruno, MD
• Phone: 706-721-1691
• Email: abruno[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 56 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognition Disorder
• Cognition Disorders
• Cognitive Dysfunction

Intervention

Device:
• remote ischemic conditioning
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.

Locations

Country	Name	City	State
United States	Wellstar MCG Health	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Augusta University	Georgia Rehabilitation Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RBC deformability index	from baseline to 4 weeks of treatment and one week off treatment	5 weeks total study duration
Secondary	inflammatory and anti-inflammatory Interleukins	ability to tolerate and adhere to protocol treatments.	5 weeks
Secondary	tolerability	any discontinuation and adverse events during treatment.	4 weeks