Remote Ischemic Conditioning for Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to improve heart and metabolic health for people with spinal cord injuries (SCI) through remote ischemic conditioning (RIC). Participants will use a blood pressure cuff at home to determine if this technique can enhance their health. The trial compares various cuff usage methods to identify the most effective approach. People with SCI who live in the community and are not currently exercising might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve health outcomes for SCI patients.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken blood thinners or are taking GLP-1 medications. It's best to discuss your medications with the trial team.
What prior data suggests that remote ischemic conditioning is safe for persons with spinal cord injury?
Research has shown that remote ischemic conditioning (RIC) is generally safe and well-tolerated for improving brain health. One study described RIC as using a blood pressure cuff to briefly stop and restart blood flow, which can help protect body tissues from harm.
Another study found that RIC can enhance blood flow and guard against heart and blood vessel damage. This suggests the treatment is safe for people with spinal cord injuries who might want to join a trial. While more research is needed, current evidence supports RIC as a safe option for improving heart and metabolic health.12345Why are researchers excited about this trial?
Researchers are excited about Remote Ischemic Conditioning (RIC) for spinal cord injury because it offers a unique, non-invasive approach compared to traditional treatments like surgery or medications. RIC involves using a blood pressure cuff to temporarily restrict blood flow in an arm, which might help protect and repair spinal cord tissues by triggering the body's natural defense mechanisms. Unlike other treatments that directly target the injury site, RIC harnesses the body's systemic response, potentially offering a broader protective effect. Plus, it's convenient for patients, as this technique can be done at home, making it a practical option for long-term use.
What evidence suggests that this trial's remote ischemic conditioning treatments could be effective for improving cardiometabolic health in spinal cord injury?
This trial will compare different methods of remote ischemic conditioning (RIC) for spinal cord injury. Research has shown that RIC might improve neurological conditions, such as spinal cord injuries. Studies have found that RIC can protect against damage from reduced blood flow, benefiting heart and nerve health. Early findings suggest RIC might enhance muscle strength and balance, especially when combined with other exercises. RIC involves using a blood pressure cuff to temporarily reduce blood flow, which activates protective effects in the body. Although more research is needed, early results are promising for improving health in people with spinal cord injuries.12345
Who Is on the Research Team?
Kerri A Morgan, PhD
Principal Investigator
Washington University School of Medicine - Program in Occupational Therapy
Are You a Good Fit for This Trial?
This trial is for adults (18+) with a spinal cord injury who are medically stable, live in the community (not a nursing facility), aren't currently exercising, and can get their doctor's approval. Participants must be able to attend assessment visits and do home-based sessions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 6-week remote ischemic conditioning (RIC) intervention at home, with daily logs of sessions
Post-assessment
Participants complete a 2-day post-assessment to evaluate cardiometabolic health outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RIC
Trial Overview
The study tests three ways of doing remote ischemic conditioning (RIC) at home: high-dose using an automated cuff, high-dose using a standard blood pressure cuff, and low-dose using a standard cuff. The goal is to see which method best improves heart and metabolic health.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
The Craig H. Neilsen Foundation
Collaborator
Citations
Remote Ischemic Conditioning for Spinal Cord Injury
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Remote Ischemic Conditioning for PwSCI | NCT07488793
This pilot study will test the feasibility and acceptability of remote ischemic conditioning implemented in a home setting by persons with SCI and collect ...
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