Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Georgia Rehabilitation Institute | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sham | Sham Comparator | BP cuff bilateral arm compression to 50 mmHg. |
|
| 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. |
|
| 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. |
|
| dose 3 | Active Comparator | BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off once daily. |
|
| dose 4 | Active Comparator | BP cuff bilateral arm compression to 50 mmHg above systolic BP for 5 minutes on/off twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote ischemic conditioning | Device | suprasystolic BP sequential compression of both arms with blood pressure cuffs for 5 min on/off for 4 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| RBC deformability index | from baseline to 4 weeks of treatment and one week off treatment | 5 weeks total study duration |
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory and anti-inflammatory Interleukins | ability to tolerate and adhere to protocol treatments. | 5 weeks |
| tolerability | any discontinuation and adverse events during treatment. |
Not provided
Inclusion Criteria:
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Askiel Bruno, MD | Contact | 706-721-1691 | abruno@augusta.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carol Smith, RN | Wellstar MCG Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellstar MCG Health | Recruiting | Augusta | Georgia | 30912 | United States |
yes, upon reasonable request.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
randomized
Not provided
Not provided
concealed allocations and blinded laboratory personnel.
|
| 4 weeks |