A Novel Cooling Vest to Protect Persons With SCI From Hyperthermia

Technology
General health
Online since 10 November 2022, updated 473 days ago

About this trial

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 expos...

Included participants

Gender
All
Age
18 - 68 years
Injury level
C4 - T2
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    ≥ 1 year
    Healthy volunteers
    Yes
    C4-T2
    Additionally, participants must
    NO cardiovascular, kidney or untreated thyroid disease
    NO diabetes mellitus
    NO cardiac pacemaker or other implanted electromedical device

    What’s involved

    Type

    Technology

    Details

    Problem Statement: Loss of supraspinal control of autonomic pathways interrupts homeostasis of multiple organ systems including thermoregulation. Thermoregulatory mechanisms are dysfunctional due to interrupted sympathetic pathways for hypothalamic control of vasomotor and sudomotor function and motor/sensory pathways for shivering and thermal sensation. During exposure to warm seasonal temperatures, dysregulation of heat dissipating mechanisms (vasodilation and sweating) allows core body temperature (Tcore) to rise in persons with SCI rather than remaining stable and tightly regulated (~37°0.6°C), as occurs in able-bodied (AB) persons. The investigators have reported in persons with higher lesions (SCI >T6: Hi-SCI), that even limited exposure (1-2 hours) to typical summer temperatures (35°C) can result in Tcore rising to values approaching hyperthermia ( 38°C). Mild hyperthermia causes physical discomfort and can impair cognition. Unchecked, hyperthermia can progress to heat exhaustion and heat stroke causing seizures, loss of consciousness, and potentially death, as occurred in vulnerable residents of the Pacific Northwest during a heat wave in late June 2021. Current medical advice for those with SCI is to avoid direct sunlight, dress sparingly, drink plenty of fluids, and stay indoors on hot, humid days. Despite heeding this advice, persons with SCI frequently find themselves in hot environments for prolonged periods during social, religious, or work functions. During these conditions, there is rapid progression to feeling "overheated" and an increased risk for heat-related illness. Warm seasonal temperatures limit perceived comfort, performance of activities, and participation in societal functions to a greater extent in persons with cervical injury (tetraplegia) than in AB controls. Identifying a safe, non-invasive, efficacious bioengineering intervention to restore thermoregulatory function during heat exposure has the potential to minimize the negative impact of heat on activities, participation, and quality of life (QOL) in Veterans with SCI. If efficacious, other Veteran populations adversely affected by heat exposure may also benefit from this intervention. Goals: This pilot study will develop and test a self-regulating cooling vest for Veterans with SCI that can utilize both conductive and evaporative methods to dissipate body heat as a proof-of-concept to prevent an excessive rise in Tcore and thermal discomfort during controlled exposure to a warm environment. An initial prototype of the vest has been developed in collaboration with Dr. Hao Su, a Co-Investigator. This initial prototype requires further development prior to human subject testing. If this study is successful, the investigators will collaborate with the Human Engineering Research Laboratory (HERL) to make the vest appropriate for home testing to determine its effectiveness in improving societal participation and QOL in Veterans with SCI during warmer seasons or when residing in or traveling to hot climate zones. Primary Objective (Safety): To complete development of the 2nd prototype of the cooling vest and determine its safety. After satisfying bench testing criteria, AB participants will wear the wet cooling vest at maximal settings for 2 hours in the seated position in a warm thermal chamber (35°C), to determine: (1) minimum skin temperatures beneath the cooling vest and (2) subjective comfort of the cooling vest. Primary Hypotheses: (1) Skin temperatures beneath the vest will be 20°C to protect against cold injury. (2) AB participants will report a thermal sensation (TS) no less than "cool" on a validated 9-point thermal sensation scale. If during testing, a skin temperature of <20°C is measured or a TS < "cool", or "cold spots" are reported, vest development will continue to ensure that the prototype is safe for testing in persons with SCI. Once safety criteria for the cooling vest are met in AB subjects, efficacy testing will be performed in persons with SCI who will wear the cooling vest during a controlled warm challenge. Secondary Objective (Efficacy in SCI): To determine the efficacy of the wet cooling vest to maintain Tcore (within 0.3°C) in participants with Hi-SCI when exposed to 2 hours of a warm environment. Using a repeated measures design, participants with Hi-SCI will wear the wet vest (experimental condition) or no vest (control condition) in a warm thermal chamber (35°C) for up to 2 hours in the seated position, to determine: (1) change in Tcore and (2) perception of heat and thermal comfort. Secondary Hypotheses: In the investigators' previous investigation of heat exposure, 65% of persons with Hi-SCI had increases of >0.5°C in Tcore (mean increase 0.6°0.3°C) while wearing only shorts. The investigators expect that wearing a cooling vest during the same heat exposure, will significantly increase heat dissipation and, thus, enhance maintenance of Tcore and thermal comfort. The investigators hypothesize that during a controlled warm exposure (35°C), participants with Hi-SCI wearing the wet cooling vest compared to the same participants not wearing a vest: 1) 65% will have a significantly reduced elevation in Tcore ( 0.3°C), and 2) a greater percentage of participants will report increased thermal comfort (decreased perception of feeling "hot", "very hot", or "uncomfortable").

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 18 Dec 2023
    • Organisation
    • VA Office of Research and Development
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 18 Dec 2023
    • Organisation
    • VA Office of Research and Development

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more