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

NCT06179797 | Unknown

• 1 other identifier: 1513705-3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• RBC deformability index

  from baseline to 4 weeks of treatment and one week off treatment

  5 weeks total study duration

Secondary Outcomes (2)

• inflammatory and anti-inflammatory Interleukins

  5 weeks

• tolerability

  4 weeks

Study Arms (5)

sham

SHAM COMPARATOR

BP cuff bilateral arm compression to 50 mmHg.

Device: remote ischemic conditioning

dose 1

ACTIVE COMPARATOR

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

dose 2

ACTIVE COMPARATOR

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

dose 3

ACTIVE COMPARATOR

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

Device: remote ischemic conditioning

dose 4

ACTIVE COMPARATOR

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

Device: remote ischemic conditioning

Interventions

remote ischemic conditioning DEVICE

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

Also known as: RIC

dose 1; dose 2; dose 3; dose 4; sham

Eligibility Criteria

• Age: 56 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• \. Contraindication to transient arm ischemia in either arm (such as symptomatic peripheral artery disease).

Sponsors & Collaborators

• Augusta University: lead
• Georgia Rehabilitation Institute: collaborator

Study Sites (1)

Wellstar MCG Health

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Carol Smith, RN

  Wellstar MCG Health

  STUDY DIRECTOR

Central Study Contacts

Askiel Bruno, MD

CONTACT

706-721-1691; abruno@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: concealed allocations and blinded laboratory personnel.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: randomized

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: August 15, 2020
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

US (1)