Spinal Cord InjuriesNCT07488793
Remote Ischemic Conditioning for PwSCI
A study testing RIC high-dose standard blood pressure cuff, RIC high-dose automated blood flow restriction cuff and RIC low-dose standard blood pressure cuff in people with Spinal Cord Injuries, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The long-term goal of this project is to improve the overall cardiometabolic health of persons with spinal cord injury (SCI). This pilot study will test the feasibility and acceptability of remote ischemic conditioning implemented in a home setting by persons with SCI and collect cardiometabolic health outcomes to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- RIC high-dose standard blood pressure cuff, RIC high-dose automated blood flow restriction cuff and RIC low-dose standard blood pressure cuff
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosis of SCI
- Live within the community (not nursing facility)
- Not actively engaged in physical activity for exercise
- Not having the ability to participate in physical activity due to physical capacity or environmental barriers
- Medically stable
- Ability to obtain physician approval to participate in the study
- Willingness to participate in a 2-day initial assessment visit at research testing location, 30 intervention sessions conducted independently by the participant or caregivers, 2-day post intervention assessment visit at research testing location.
Who cannot join
- Medically unstable
- Have had a heart-related condition within the past year
- Have had a blood clot in the past year
- Have a stage 3 or 4 pressure injury
- Have taken blood thinners in the past year
- Have had surgery in the past year
Show all 17Show fewer
- Have uncontrolled hypertension
- Have peripheral artery disease
- Have Complex Regional Pain Syndrome (CRPS) in both arms
- Have had nerve or tendon transfers in the arms in the past year
- Have lymphedema in the arms
- Have recent acute illness or injury (within the past 3 months)
- Currently pregnant
- Enrolled in another clinical trial
- Are taking GLP-1 medications
- Unable to provide consent
- Currently engaged in physical activity for exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
Official title: Remote Ischemic Conditioning Intervention to Enhance the Cardiometabolic Health of Persons With SCI
The long-term goal of this project is to improve the overall cardiometabolic health of persons with spinal cord injury (SCI). This pilot study will test the feasibility and acceptability of remote ischemic conditioning implemented in a home setting by persons with SCI and collect cardiometabolic health outcomes to inform appropriate outcomes for a future larger trial. Researchers will compare, RIC high dose using standard blood pressure cuff to RIC high dose using automated blood flow restriction cuff to RIC low dose using standard blood pressure cuff, to determine cardiometabolic health improvements amongst groups.
Participants will:
Complete an initial 2-day assessment, participate in a 6-week intervention using remote ischemic conditioning (RIC) within their home, complete a 2-day post assessment.
Read the detailed description
The goal of this clinical trial is to collect preliminary data on examining the effects of remote ischemic conditioning (RIC) on cardiometabolic health outcomes for persons with spinal cord injury (SCI).
The main aims are:
To identify barriers, facilitators and reasons for positive determinants for implementation of RIC in a home setting.
To estimate improvements in cardiometabolic health of participants with SCI enrolled in an in-home, high-dose RIC intervention group compared to a low-dose RIC group.
The long-term impact will be implementing evidence-based interventions that are achievable and accessible to persons with SCI for improving cardiovascular and metabolic morbidity and mortality outcomes.
- Conditions
- Spinal Cord Injuries
- Being tested
- RIC high-dose standard blood pressure cuff, RIC high-dose automated blood flow restriction cuff, RIC low-dose standard blood pressure cuff
- Keywords
- remote ischemic conditioning, spinal cord injury, cardiometabolic health
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIC high-dose standard blood pressure cuffBehavioural
The RIC high-dose using a standard blood pressure cuff group will participate in 6-weeks of self or support-person applied/assisted remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participants will complete 1 session of 4 cycles of inflating/deflating a standard blood pressure cuff to 20 mmHg higher than their measured systolic blood pressure on an arm. The blood pressure cuff will be inflated and held for 5 minutes, then deflated (released) for 5 minutes and this will be repeated a total of 4 cycles. This process will take about 35 minutes to complete each day. The participants will also complete a daily log of their RIC sessions. The overall goal is to improve cardiometabolic health of persons with spinal cord injury.
RIC high-dose automated blood flow restriction cuffBehavioural
The RIC high-dose automated blood flow restriction cuff group will participate in 6-weeks of self or support-person applied/assisted remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participants will complete 1 session of 4 cycles of inflation/deflation of an automated blood flow restriction cuff to 20 mmHg higher than their measured systolic blood pressure on an arm. The restriction cuff will inflate and hold for 5 minutes, then deflate (release) for 5 minutes and this will be repeated a total of 4 cycles. This process will take about 35 minutes to complete each day. The participants will also complete a daily log of their RIC sessions. The overall goal is to improve the cardiometabolic health of persons with spinal cord injury.
RIC low-dose standard blood pressure cuffBehavioural
The RIC low-dose standard blood pressure cuff group will participate in 6-weeks of self or support-person applied/assisted remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participants will complete 1 session of 4 cycles of inflating/deflating a blood pressure cuff to 10 mmHg below their measured diastolic blood pressure on an arm. The blood pressure cuff will be inflated and held for 5 minutes, then deflated (released) for 5 minutes and this will be repeated a total of 4 cycles. This process will take about 35 minutes to complete each day. The participants will also complete a daily log of their RIC sessions.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic conditions (RIC) high-dose using standard blood pressure cuff | Active comparator | A group provided 6-weeks of remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participant will complete 1 session of 4 cycles of inflating/deflating a standard blood pressure cuff to 20 mmHg higher than their measured systolic blood pressure on an arm. The participant will also complete a daily log of their RIC sessions. Receives: Behavioral: RIC high-dose standard blood pressure cuff |
| Remote ischemic conditioning (RIC) high-dose using the automated blood flow restriction cuff | Active comparator | A group provided 6-weeks of remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participant will complete 1 session of 4 cycles of inflation/deflation of an automated blood flow restriction cuff to 20 mmHg higher than their measured systolic blood pressure on an arm. The participant will also complete a daily log of their RIC sessions. Receives: Behavioral: RIC high-dose automated blood flow restriction cuff |
| Remote ischemic conditioning (RIC) low-dose using standard blood pressure cuff | Placebo comparator | A group provided 6-weeks of remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participant will complete 1 session of 4 cycles of inflating/deflating a blood pressure cuff to 10 mmHg below their measured diastolic blood pressure on an arm. The participant will also complete a daily log of their RIC sessions. Receives: Behavioral: RIC low-dose standard blood pressure cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery diameter change (cm)
Participants will undergo a Brachial Artery Reactivity Test (BART) via upper arm doppler ultrasound. The test will measure flow-mediated dilation and endothelium independent dilation of the brachial artery using a high-resolution transducer on the Vivid E95, E9, Vivid IQ (portable) or Vivid I (portable) systems. Brachial artery flow-mediated vasodilation correlates with measures of coronary artery endothelial function and can predict future adverse coronary events. Results will be reported as brachial artery diameter change between baseline and 30 seconds into test, unit of measure is cm.
Measured: Baseline and up to 2 weeks post intervention
Arterial stiffness - Pulse wave velocity (PWV)
This test is a non-invasive cardiovascular assessment that measures arterial stiffness. Arterial stiffness will be obtained by measuring carotid-femoral pulse wave velocity using the SphygmoCor XCEL system.
Measured: Baseline and up to 2 weeks post intervention
Secondary outcomes (4)
Inflammation change - High sensitivity C reactive protein - hsCRP - (mg/L, reported as % change)
Participants will have blood drawn two times at initial assessment and two times at post assessment. The first draw will happen immediately before a session of remote ischemic conditioning (RIC) and then immediately after the session. The hsCRP results will measure inflammation within the body, elevated hsCRP levels are associated with an increased risk of cardiovascular disease.
Measured: Baseline and up to 2-weeks post intervention
Immune system activation/response change - Interleukin 6 - IL-6 - (pg/mL, reported as % change)
Participants will have blood drawn two times at initial assessment and two times at post assessment. The first draw will happen immediately before a session of remote ischemic conditioning (RIC) and then immediately after the session. The IL-6 results will measure pro- and anti- inflammatory responses, this will be reported as one score, higher levels are associated with an increased pro-inflammatory response and lower levels are associated with an anti-inflammatory response.
Measured: Baseline and up to 2-weeks post intervention
Low density lipoprotein cholesterol (LDL) change - (mg/dL, reported as % change)
Participants will have blood drawn one time at initial assessment and one time at post assessment. The LDL results will measure the amount of LDL within the blood. High levels of LDL can lead to plaque buildup in the arteries, increasing the risk of cardiovascular disease.
Measured: Baseline and up to 2-weeks post intervention
High-density lipoprotein cholesterol (HDL) change - (mg/dL, reported as % change)
Participants will have blood drawn one time at initial assessment and one time at post assessment. The HDL results will measure the amount of HDL within the blood. High levels of HDL are associated with a lower risk of cardiovascular disease.
Measured: Baseline and up to 2-weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start23 Feb 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Kerri Morgan, Washington University School of Medicine
- Investigators
- Kerri A Morgan, PhD, Principal investigator, Washington University School of Medicine - Program in Occupational Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488793
- Sponsor's protocol ID
- 202504164
- Other IDs
- 1348401
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning Intervention to Enhance the Cardiometabolic Health of Persons With SCI
- ClinicalTrials.gov ID
- NCT07488793
- Acronym / sponsor ID
- 202504164
- Conditions
- Spinal Cord Injuries
- Keywords
- remote ischemic conditioning, spinal cord injury, cardiometabolic health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 23 Mar 2026 (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.
The long-term goal of this project is to improve the overall cardiometabolic health of persons with spinal cord injury (SCI). This pilot study will test the feasibility and acceptability of remote ischemic conditioning implemented in a home setting by persons with SCI and collect cardiometabolic health outcomes to inform appropriate outcomes for a future larger trial. Researchers will compare, RIC high dose using standard blood pressure cuff to RIC high dose using automated blood flow restriction cuff to RIC low dose using standard blood pressure cuff, to determine cardiometabolic health improvements amongst groups.
Participants will:
Complete an initial 2-day assessment, participate in a 6-week intervention using remote ischemic conditioning (RIC) within their home, complete a 2-day post assessment.
Detailed description
The goal of this clinical trial is to collect preliminary data on examining the effects of remote ischemic conditioning (RIC) on cardiometabolic health outcomes for persons with spinal cord injury (SCI).
The main aims are:
To identify barriers, facilitators and reasons for positive determinants for implementation of RIC in a home setting.
To estimate improvements in cardiometabolic health of participants with SCI enrolled in an in-home, high-dose RIC intervention group compared to a low-dose RIC group.
The long-term impact will be implementing evidence-based interventions that are achievable and accessible to persons with SCI for improving cardiovascular and metabolic morbidity and mortality outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditions (RIC) high-dose using standard blood pressure cuff | Active comparator | Behavioral: RIC high-dose standard blood pressure cuffA group provided 6-weeks of remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participant will complete 1 session of 4 cycles of inflating/deflating a standard blood pressure cuff to 20 mmHg higher than their measured systolic blood pressure on an arm. The participant will also complete a daily log of their RIC sessions. |
| Remote ischemic conditioning (RIC) high-dose using the automated blood flow restriction cuff | Active comparator | Behavioral: RIC high-dose automated blood flow restriction cuffA group provided 6-weeks of remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participant will complete 1 session of 4 cycles of inflation/deflation of an automated blood flow restriction cuff to 20 mmHg higher than their measured systolic blood pressure on an arm. The participant will also complete a daily log of their RIC sessions. |
| Remote ischemic conditioning (RIC) low-dose using standard blood pressure cuff | Placebo comparator | Behavioral: RIC low-dose standard blood pressure cuffA group provided 6-weeks of remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participant will complete 1 session of 4 cycles of inflating/deflating a blood pressure cuff to 10 mmHg below their measured diastolic blood pressure on an arm. The participant will also complete a daily log of their RIC sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- Diagnosis of SCI
- Live within the community (not nursing facility)
- Not actively engaged in physical activity for exercise
- Not having the ability to participate in physical activity due to physical capacity or environmental barriers
Key exclusion criteria (17 listed)
- Medically unstable
- Have had a heart-related condition within the past year
- Have had a blood clot in the past year
- Have a stage 3 or 4 pressure injury
- Have taken blood thinners in the past year
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 |
|---|---|---|
| RIC high-dose standard blood pressure cuffThe RIC high-dose using a standard blood pressure cuff group will participate in 6-weeks of self or support-person applied/assisted remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participants will complete 1 session of 4 cycles of inflating/deflating a standard blood pressure cuff to 20 mmHg higher than their measured systolic blood pressure on an arm. The blood pressure cuff will be inflated and held for 5 minutes, then deflated (released) for 5 minutes and this will be repeated a total of 4 cycles. This process will take about 35 minutes to complete each day. The participants will also complete a daily log of their RIC sessions. The overall goal is to improve cardiometabolic health of persons with spinal cord injury. | Behavioural | Remote ischemic conditions (RIC) high-dose using standard blood pressure cuff |
| RIC high-dose automated blood flow restriction cuffThe RIC high-dose automated blood flow restriction cuff group will participate in 6-weeks of self or support-person applied/assisted remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participants will complete 1 session of 4 cycles of inflation/deflation of an automated blood flow restriction cuff to 20 mmHg higher than their measured systolic blood pressure on an arm. The restriction cuff will inflate and hold for 5 minutes, then deflate (release) for 5 minutes and this will be repeated a total of 4 cycles. This process will take about 35 minutes to complete each day. The participants will also complete a daily log of their RIC sessions. The overall goal is to improve the cardiometabolic health of persons with spinal cord injury. | Behavioural | Remote ischemic conditioning (RIC) high-dose using the automated blood flow restriction cuff |
| RIC low-dose standard blood pressure cuffThe RIC low-dose standard blood pressure cuff group will participate in 6-weeks of self or support-person applied/assisted remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participants will complete 1 session of 4 cycles of inflating/deflating a blood pressure cuff to 10 mmHg below their measured diastolic blood pressure on an arm. The blood pressure cuff will be inflated and held for 5 minutes, then deflated (released) for 5 minutes and this will be repeated a total of 4 cycles. This process will take about 35 minutes to complete each day. The participants will also complete a daily log of their RIC sessions. | Behavioural | Remote ischemic conditioning (RIC) low-dose using standard blood pressure cuff |
Primary outcome
Brachial artery diameter change (cm)
Time frame: Baseline and up to 2 weeks post intervention
Participants will undergo a Brachial Artery Reactivity Test (BART) via upper arm doppler ultrasound. The test will measure flow-mediated dilation and endothelium independent dilation of the brachial artery using a high-resolution transducer on the Vivid E95, E9, Vivid IQ (portable) or Vivid I (portable) systems. Brachial artery flow-mediated vasodilation correlates with measures of coronary artery endothelial function and can predict future adverse coronary events. Results will be reported as brachial artery diameter change between baseline and 30 seconds into test, unit of measure is cm.
Arterial stiffness - Pulse wave velocity (PWV)
Time frame: Baseline and up to 2 weeks post intervention
This test is a non-invasive cardiovascular assessment that measures arterial stiffness. Arterial stiffness will be obtained by measuring carotid-femoral pulse wave velocity using the SphygmoCor XCEL system.
4 secondary outcomes
Inflammation change - High sensitivity C reactive protein - hsCRP - (mg/L, reported as % change)
Time frame: Baseline and up to 2-weeks post intervention
Immune system activation/response change - Interleukin 6 - IL-6 - (pg/mL, reported as % change)
Time frame: Baseline and up to 2-weeks post intervention
Low density lipoprotein cholesterol (LDL) change - (mg/dL, reported as % change)
Time frame: Baseline and up to 2-weeks post intervention
High-density lipoprotein cholesterol (HDL) change - (mg/dL, reported as % change)
Time frame: Baseline and up to 2-weeks post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Related trials for Spinal Cord Injuries
Recruiting
Comparison Between Objective Biomechanical Cost and Perceived Physical Demand in Manual Wheelchair Users During Propulsion Tasks
Manual Wheelchair Use, Spinal Cord Injury
Not yet recruitingObservational study
Risk Factors for Spinal Cord Injury After Minimally Invasive Aortic Repair
Spinal Cord Ischemia
Not yet recruiting
Feasibility of Transcutaneous Spinal Stimulation in Rehabilitation
Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injuries (SCI)
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruiting
Functional Electrical Stimulation Plus High Intensity Interval Training at Home
Spinal Cord Injuries (SCI)
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.
Kerri A Morgan, PhD principal investigator
Washington University School of Medicine - Program in Occupational Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIC high-dose standard blood pressure cuff, RIC high-dose automated blood flow restriction cuff and RIC low-dose standard blood pressure cuff in people with Spinal Cord Injuries, run by Washington University School of Medicine 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 8 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerri A Morgan, PhD (314-286-1659, morgank@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery diameter change (cm) (time frame: Baseline and up to 2 weeks post intervention). The study lists 2 primary outcomes in all. 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 23 Mar 2026.