Home-Based Heat Therapy in Spinal Cord Injury to Improve Cardiovascular Health (IIS_SCIDoD)

Home-Based Passive Heat Therapy-Towards a Scalable Intervention to Improve Cardiovascular Health in Persons With Spinal Cord Injury

The study is designed to investigate the effects of passive heat therapy on blood vessel health in 40 people (48 enrolled with attrition rate of 20%). Following an extensive set of vascular function tests, participants will engage in either a passive heat therapy intervention for 60 minutes, 4 times a week for 8 weeks, or a placebo intervention at a lower temperature. Seven of the 8 weeks of intervention will occur in the home setting. Vascular function tests will be repeated after the 8 weeks to determine if chronic passive heat stress improved vascular health.

Study Overview

• Status: Recruiting
• Conditions: SCI - Spinal Cord Injury
• Intervention / Treatment: Other: HEAT - Passive Heat Therapy; Other: Sham (No Treatment)

Detailed Description

The experimental arm (HEAT) participants undergo an 8-week intervention with 4 weekly passive heat therapy sessions. The aim of each session is to raise the participants' core temperature by at least 1°C by resting under heating blankets set at approximately 42°C. The control arm (SHAM) participants undergo the same procedure as above except the temperature setting of the blankets is lower at approximately 34°C.

Screening, baseline assessments and the first 4 sessions will be conducted in the investigator's SCI lab to familiarize the participant with how to apply the heating blankets and ensure safety. After the 4th session, participants will receive a heating blanket for use at home in the remaining 7 intervention weeks. Cardiac MRI and peripheral vascular assessments are performed at baseline and within two weeks after completing the intervention. Weekly sessions (4x per week) in weeks 2 to 8 will be performed at home and secure VA-approved online video conferencing software will be used by study staff to remotely supervise the sessions and collect data.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Trbovich, MD; Phone Number: 16986 210-617-5300; Email: michelle.trbovich@va.gov
• Study Contact Backup: Name: Dean L Kellogg, Jr, MD, PhD; Phone Number: 210-617-5300; Email: kelloggd@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Audie L Murphy Veterans Memorial Hospital, South Texas Veterans Health Care System
      • Contact: Michelle Paprocki, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEAT; The experimental arm (HEAT) participants undergo an 8-week intervention with 4 weekly passive heat therapy sessions (home based for 7 of 8 weeks) using an electrical heating blanket at a temperature of 42 degrees C.	Other: HEAT - Passive Heat Therapy; Participant rests under a heated blanket until the core body temperature has increased at minimum 1 degree Celsius. This usually takes approximately 1 hour. The intervention is performed 4 times a week for a total of 8 weeks.
Sham Comparator: SHAM; For participants in SHAM, the heating blankets will be warm (~34°C) but will not reach a temperature that elevates core temperature. As in the HEAT arm, sessions will be home based for 7 of 8 weeks.	Other: Sham (No Treatment); The SHAM intervention participant will rest under a heated blanket that is not set to the degree that the HEAT arm receives. There is no increase of core body temperature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laser Doppler Flowmetry (LDF)	Measure of skin blood flow due to local skin heating	From baseline to end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial Peripheral Arterial Tone (EndoPAT)	Measures the changes in finger pulsatile arterial volume	Baseline to end of treatment at 8 weeks
Venous Occlusion Plethysmography (VOP)	Limb blood flow measurement	From baseline to end of treatment at 8 weeks
Cardiac MRI	Measures stiffness of the aorta	Baseline to end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Congressionally Directed Medical Research Programs
• Investigators: Principal Investigator: Michelle Trbovich, MD, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: vascular function; SCI; heat therapy; heat stress; passive heat
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Body Temperature Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hyperthermia; Spinal Cord Injuries; Heat Stress Disorders; salicylhydroxamic acid
• Other Study ID Numbers: STUDY00002046; CDMRP-SC240010 (Other Grant/Funding Number: Congressionally Directed Medical Research Programs (CDMRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No