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

NCT07317843 | Recruiting

• 2 other identifiers: STUDY00002046CDMRP-SC240010
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SCI - Spinal Cord Injury

Keywords

SCI; heat therapy; heat stress; passive heat; vascular function

Outcome Measures

Primary Outcomes (1)

• Laser Doppler Flowmetry (LDF)

  Measure of skin blood flow due to local skin heating

  From baseline to end of treatment at 8 weeks

Secondary Outcomes (3)

• Endothelial Peripheral Arterial Tone (EndoPAT)

  Baseline to end of treatment at 8 weeks

• Venous Occlusion Plethysmography (VOP)

  From baseline to end of treatment at 8 weeks

• Cardiac MRI

  Baseline to end of treatment at 8 weeks

Study Arms (2)

HEAT

EXPERIMENTAL

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

SHAM

SHAM COMPARATOR

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)

Interventions

HEAT - Passive Heat Therapy OTHER

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.

HEAT

Sham (No Treatment) OTHER

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.

SHAM

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant demonstrates understanding of the study and has provided an appropriately signed and dated informed consent.
• Participants will be male or female, 18-60 years of age, at the time of Visit 0.
• 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.
• Stable SCI (AIS A or B) of longer than 1-year duration.

You may not qualify if:

• Participants who smoke, or:
• Uses daily administration of vasoactive medications (e.g., alpha antagonists or agonists or phosphodiesterase inhibitors).
• Has a current pressure ulcer or skin breakdown.
• Has an active, uncontrolled, autoimmune or inflammatory disorder
• Has no history of or current alcohol or substance use disorder
• Has a history of heat related illness (e.g., heat stroke)
• 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.
• Is unlikely to cooperate with the requirements of the study.

Sponsors & Collaborators

• Congressionally Directed Medical Research Programs: collaborator
• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Audie L Murphy Veterans Memorial Hospital, South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Hyperthermia; Heat Stress Disorders

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelle Trbovich, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Trbovich, MD

CONTACT

210-617-5300; michelle.trbovich@va.gov

Dean L Kellogg, Jr, MD, PhD

CONTACT

210-617-5300; kelloggd@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 5, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): July 1, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)