Arm 1: Cooling Vest for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
James J. Peters VA Medical Center, Bronx, NY, Bronx, NY
Spinal Cord Injuries+1 More
Cooling Vest - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Spinal Cord Injuries

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Spinal Cord Injuries

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Baseline (0 min) and end of thermal challenge (120 min) will be compared

Baseline (0 min) and end of thermal challenge (120 min) will be compared
Skin temperature (Tsk) change
Thermal Sensation (TS) change
Baseline (0 min) and end of thermal challenge (120 min) will be compared in persons with Hi-SCI
Core body temperature (Tcore) change
Thermal comfort (TC) change

Trial Safety

Safety Progress

1 of 3

Other trials for Spinal Cord Injuries

Trial Design

3 Treatment Groups

Arm 3: No Vest
1 of 3
Arm 1: Cooling Vest
1 of 3
Arm 2: Cooling Vest
1 of 3
Active Control
Experimental Treatment

15 Total Participants · 3 Treatment Groups

Primary Treatment: Arm 1: Cooling Vest · No Placebo Group · N/A

Arm 1: Cooling Vest
Device
Experimental Group · 1 Intervention: Cooling Vest · Intervention Types: Device
Arm 2: Cooling Vest
Device
Experimental Group · 1 Intervention: Cooling Vest · Intervention Types: Device
Arm 3: No VestNoIntervention Group · 1 Intervention: Arm 3: No Vest · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cooling Vest
2017
N/A
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (0 min) and end of thermal challenge (120 min) will be compared
Closest Location: James J. Peters VA Medical Center, Bronx, NY · Bronx, NY
Photo of Bronx  1Photo of Bronx  2Photo of Bronx  3
2007First Recorded Clinical Trial
14 TrialsResearching Spinal Cord Injuries
25 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Level of injury C4-T2, ASIA Impairment Scale A & B.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.