Age-related Cerebral White Matter ChangesNCT06179797
Chronic Remote Ischemic Conditioning in Vascular Cognitive Impairment: A Dose Escalation Study
A study testing remote ischemic conditioning in people with Age-related Cerebral White Matter Changes and Cognition Disorder, run by Augusta University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 56 years and older
- Conditions the study is for
- Age-related Cerebral White Matter Changes, Cognition Disorder
- What is being tested?
- remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2020to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wellstar MCG Health
Augusta, Georgia, 30912
Askiel Bruno, MD, 706-721-1691, abruno@augusta.edu
About this 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.
Read the 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.
- Being tested
- remote ischemic conditioning
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic conditioningDevice
Also called RIC
suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| sham | Sham comparator | BP cuff bilateral arm compression to 50 mmHg. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBC deformability index
from baseline to 4 weeks of treatment and one week off treatment
Measured: 5 weeks total study duration
Secondary outcomes (2)
inflammatory and anti-inflammatory Interleukins
ability to tolerate and adhere to protocol treatments.
Measured: 5 weeks
tolerability
any discontinuation and adverse events during treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start15 Aug 2020
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Cerebral White Matter ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Rehabilitation Institute
- Responsible party
- Principal investigator, Askiel Bruno, Augusta University
- Investigators
- Carol Smith, RN, Study director, Wellstar MCG Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179797
- Sponsor's protocol ID
- 1513705-3
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: yes, upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Remote Ischemic Conditioning in Vascular Cognitive Impairment: A Dose Escalation Study
- ClinicalTrials.gov ID
- NCT06179797
- Acronym / sponsor ID
- 1513705-3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Georgia Rehabilitation Institute
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- randomized
| Arm | Type | Receives |
|---|---|---|
| sham | Sham comparator | Device: remote ischemic conditioningBP cuff bilateral arm compression to 50 mmHg. |
| dose 1 | Active comparator | Device: remote ischemic conditioningBP cuff bilateral arm compression to 50 mmHg above systolic BP for 2.5 minutes on/off for 4 cycles every other day. |
| dose 2 | Active comparator | Device: remote ischemic conditioningBP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off for 4 cycles every other day. |
| dose 3 | Active comparator | Device: remote ischemic conditioningBP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off once daily. |
| dose 4 | Active comparator | Device: remote ischemic conditioningBP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off twice daily. |
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischemic conditioningAlso: RICsuprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles. | Device | dose 1, dose 2, dose 3, dose 4, sham |
Primary outcome
RBC deformability index
Time frame: 5 weeks total study duration
from baseline to 4 weeks of treatment and one week off treatment
2 secondary outcomes
inflammatory and anti-inflammatory Interleukins
Time frame: 5 weeks
tolerability
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: Undecided. yes, upon reasonable request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Smith, RN study director
Wellstar MCG Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic conditioning in people with Age-related Cerebral White Matter Changes and Cognition Disorder, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Askiel Bruno, MD (706-721-1691, abruno@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RBC deformability index (time frame: 5 weeks total study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.