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N/A N=15 Randomized Device Feasibility

A Novel Cooling Vest to Protect Persons With SCI From Hyperthermia

Spinal Cord Injuries

Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Skin Temperature (Tsk) Change — -5.6; -6.9; 2.1 Degrees Celsius — p=0.002

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Cooling Vest (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Jan 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Skin Temperature (Tsk) Change
-5.6; -6.9; 2.1 0.002 sig
PRIMARY
Thermal Sensation (TS) Change
-2.1; 0.5; 2.6 0.043 sig
SECONDARY
Core Body Temperature (Tcore) Change
-0.1; 0.8 0.352
SECONDARY
Thermal Comfort (TC) Change
0.4; 0.9; 0.8 0.374

Summary

Persons with higher levels of spinal cord injury (above the 6th thoracic vertebrae: Hi-SCI) are unable to maintain their core body temperature (Tcore) within the normal range (97.5-99.7 °F) when exposed to warm environments. Even limited exposure to warm temperatures can cause hyperthermia (Tcore 100.4°F) in Hi-SCI. Mild hyperthermia causes discomfort and impaired thinking, but if unchecked, can lead to permanent damage to the brain, multiple body organ failure, and death. Warm seasonal temperatures have an adverse effect on personal comfort and the ability to participate in daily social activities in persons with Hi-SCI. Interventions addressing this vulnerability to hyperthermia are limited. A self-regulating "smart" cooling vest designed for persons with Hi-SCI, that can effectively dissipate body heat, is a novel and promising strategy to address this problem. Once the current prototype is further developed and bench-tested, the investigators will test the vest in able-bodied participants for safety and comfort. The investigators will then test the vest in participants with Hi-SCI for efficacy. The aim for the cooling vest to minimize the expected increase of 1.1°F in Tcore by at least 50 percent and increase thermal comfort, during a controlled exposure to heat (95°F). If successful, the vest will provide a promising intervention to decrease the adverse impact of warm temperatures on comfort, quality of life, and participation in societal functions for Veterans with Hi-SCI during the warmer seasons.

Eligibility Criteria

Inclusion Criteria

  • Spinal cord injury (SCI) >1 year in duration
  • Level of SCI C4-T2, ASIA Impairment Scale A & B
  • Gender and age-matched (±5 years) able-bodied (AB) controls
  • Euhydration (participants will be instructed to avoid caffeine and alcohol, maintain normal salt and water intake and avoid strenuous exercise for 24 hours prior to study)

Exclusion Criteria

  • Known cardiovascular, kidney or untreated thyroid disease
  • Traumatic brain injury (mod-severe)
  • Diabetes mellitus
  • Acute illness or infection
  • Broken, inflamed, or otherwise fragile skin
  • Pregnancy
  • BMI >30 kg/m2
  • Smoking Participants with SCI only (secondary to telemetry capsule (CorTemp®) measurement of Tcore)
  • Undergoing magnetic resonance imaging while the telemetry capsule is within the body (2-5 days)
  • Cardiac pacemaker or other implanted electromedical device
  • Known or suspected obstructive disease of the GI tract
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05441449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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