Heat Therapy for Spinal Cord Injury

(IIS_SCIDoD Trial)

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Overseen ByDean L Kellogg, Jr, MD, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how passive heat therapy might improve blood vessel health in people with a stable spinal cord injury (SCI). Participants will use a heating blanket set at either a therapeutic or a lower, non-therapeutic temperature for eight weeks. The goal is to determine if the therapy enhances vascular health over time. This trial suits individuals who have had a stable SCI for over a year and do not smoke or take certain medications. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to improved therapies for SCI-related vascular health.

Will I have to stop taking my current medications?

The trial does not require you to stop taking medications for managing spinal cord injury if you've been on a stable dose for at least 6 months. However, you cannot participate if you use daily steroids or certain vasoactive medications.

What prior data suggests that passive heat therapy is safe for spinal cord injury patients?

Research has shown that passive heat therapy is generally safe and well-tolerated by people with spinal cord injuries. Studies have found that participants can undergo repeated sessions without major issues. In one study, people with spinal cord injuries reported that passive heat therapy was not only safe but also helped reduce their chronic pain. Another study found that this therapy is practical and safe, suggesting it can be a good option for improving heart and blood vessel health. Overall, the evidence supports that passive heat therapy does not cause serious side effects, making it a promising treatment to consider.12345

Why are researchers excited about this trial?

Researchers are excited about passive heat therapy for spinal cord injury because it offers a non-invasive, home-based treatment option. Unlike traditional methods, which often involve medication or surgery, this therapy uses an electrical heating blanket to safely increase body temperature, potentially improving blood flow and promoting healing. Its ease of use and minimal side effects make it an appealing alternative or complement to existing treatment options, providing hope for better quality of life for those with spinal cord injuries.

What evidence suggests that passive heat therapy is effective for improving vascular health in spinal cord injury?

Research has shown that passive heat therapy, which participants in this trial may receive, might improve blood vessel health in people with spinal cord injuries. Some studies suggest that regular heat exposure can reduce long-term pain in veterans with these injuries, indicating that frequent heat therapy sessions could help manage pain. This trial will explore how this therapy affects inflammation and metabolism over eight weeks. Although more research is needed, these early findings offer promise for enhancing health and comfort in people with spinal cord injuries.56789

Who Is on the Research Team?

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Michelle Trbovich, MD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for individuals with spinal cord injury who can participate in an 8-week study to test the effects of heat therapy on blood vessel health. Participants will undergo vascular function tests and must be able to commit to four sessions per week, mostly from home.

Inclusion Criteria

Participant demonstrates understanding of the study and has provided an appropriately signed and dated informed consent
My spinal cord injury is stable and occurred over a year ago.
I am between 18 and 60 years old.
See 2 more

Exclusion Criteria

Participants who smoke
Has an active, uncontrolled, autoimmune or inflammatory disorder
Has no history of or current alcohol or substance use disorder
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Baseline Assessment

Baseline assessments including cardiac MRI and peripheral vascular assessments are performed

1 week
1 visit (in-person)

Treatment

Participants undergo an 8-week intervention with 4 weekly passive heat therapy sessions, with the first week in the lab and the remaining 7 weeks at home

8 weeks
4 visits (in-person), 28 sessions (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeat vascular function tests

2 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Passive Heat Therapy

Trial Overview

The study compares passive heat therapy (60 minutes at a therapeutic temperature) against a sham treatment (lower temperature) to see if regular heat exposure improves cardiovascular health in those with spinal cord injuries.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: HEATExperimental Treatment1 Intervention
Group II: SHAMPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

Congressionally Directed Medical Research Programs

Collaborator

Trials
59
Recruited
10,600+

Citations

The Effect of Eight Weeks of Passive Heat Therapy on Mental ...

This pilot study suggests that supervised repeated passive heat therapy may confer benefits for chronic pain in veterans with chronic SCI.

Impact of Passive Heat on Metabolic, Inflammatory and ...

This study will test the impact of repeated bouts (3x/week) of passive heat stress over a longer term (8 weeks) on inflammation, metabolism and vascular ...

Impact of passive heat stress on persons with spinal cord ...

A recent 20-year longitudinal study of persons with SCI in Scotland found hospitalizations to be more common in those who were older at time of SCI and who had ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40429561/

The Effect of Eight Weeks of Passive Heat Therapy on ...

Conclusions: This pilot study suggests that supervised repeated passive heat therapy may confer benefits for chronic pain in veterans with ...

The Effect of Eight Weeks of Passive Heat Therapy on ...

Conclusions: This pilot study suggests that supervised repeated passive heat therapy may confer benefits for chronic pain in veterans with chronic SCI. Follow- ...

Impact of passive heat stress on persons with spinal cord injury

Environmental heat stress can negatively impact health, work capacity, and athletic performance and potentially to lead to life-threatening consequences if ...

Cardioprotective Benefit of Passive Heat Therapy in Higher ...

As compared to the general population, those living with a spinal cord injury (SCI) are at a greater risk of cardiovascular (CV) diseases.

Passive heat therapy to improve cardiometabolic health in ...

Conclusion: These preliminary findings suggest that it is feasible, well-tolerated and safe for persons with SCI to engage in repeated heat ...

The Effect of Eight Weeks of Passive Heat Therapy on ...

This pilot study suggests that supervised repeated passive heat therapy may confer benefits for chronic pain in veterans with chronic SCI.