Home-based passive heat therapy to improve cardiovascular health after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional study will compare an 8-week passive heat therapy program to a lower-temperature sham in adults with chronic spinal cord injury. Participants will undergo baseline vascular function testing and cardiac MRI, then complete four 60-minute heat or sham sessions per week for eight weeks, aiming for a ≥1°C rise in core temperature in the heat group. The first four sessions are supervised in the SCI lab to teach safe blanket use, and the remaining weekly sessions are performed at home with remote VA-approved video supervision. Vascular and cardiac measures are repeated within two weeks after completing the intervention to determine chronic effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant demonstrates understanding of the study and has provided an appropriately signed and dated informed consent.
2. Participants will be male or female, 18-60 years of age, at the time of Visit 0.
3. Female participants must be non-lactating. Female patients are eligible only if they have a negative pregnancy test throughout the study period (or are postmenopausal). Postmenopausal women taking hormone replacement will be included if they have been on a stable dose for =6 months.
4. Stable SCI (AIS A or B) of longer than 1-year duration.
5. Use of medications for clinical management of medical problems directly related to SCI is not considered an exclusion criterion. Status such as detrusor instability, muscle spasms, and other common SCI problems (other than those that could alter vascular responsiveness) may be allowed for those SCI participants who have been on stable doses for =6 months. Results from participants taking such medications will be analyzed to determine possible medication-related differences from those on no medications.

Exclusion Criteria:

1. Participants who smoke, or:
2. Uses daily administration of anti-inflammatory medications (stable doses of NSAIDs or statins are acceptable; steroids are exclusionary)
3. Uses daily administration of vasoactive medications (e.g., alpha antagonists or agonists or phosphodiesterase inhibitors).
4. Has a current pressure ulcer or skin breakdown.
5. Has an active, uncontrolled, autoimmune or inflammatory disorder
6. Has no history of or current alcohol or substance use disorder
7. Has a history of heat related illness (e.g., heat stroke)
8. Has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study. This includes, but is not limited to, a clinically relevant medical or surgical history.
9. Is unlikely to cooperate with the requirements of the study.

Where it's running

• Audie L Murphy Veterans Memorial Hospital, South Texas Veterans Health Care System
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Michelle Trbovich, MD — The University of Texas Health Science Center at San Antonio
• Study coordinator: Michelle Trbovich, MD
• Email: michelle.trbovich@va.gov
• Phone: 210-617-5300

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.