A Novel Cooling Vest to Protect Persons With SCI From Hyperthermia

NCT05441449 | Completed Results FDA Device

• 1 other identifier: A4084-P
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries

Keywords

Body Temperature Regulation; Hyperthermia; Body Temperature

Outcome Measures

Primary Outcomes (2)

• Skin Temperature (Tsk) Change

  Tsk will be monitored using TX-4 Skin Surface probes and Iso-Thermex Multichannel Thermometer (Columbus Instruments, Columbus, OH). Skin thermocouples will be taped to 12 sites on the trunk (chest/abdomen) of AB controls (6 on each side) and on 10 sites on the chest/abdomen (5 on each side) and 4 sites on the bilateral hands and feet (2 on each side) for a total of 14 sites on persons with Hi-SCI determine change and minimum skin temperatures beneath the cooling vest

  Baseline (0 min) and end of thermal challenge (120 min) will be compared

• Thermal Sensation (TS) Change

  TS will be measured by a 9-point (+4 to -4) thermal sensation scale (+4 Very Hot. +3 Hot, +2 Warm, +1 Slightly Warm, 0 Neutral, -1 Slightly Cool, -2 Cool, -3 Cold, -4 Very Cold). During a thermal challenge, a subjective score of "0" (Neutral) would be preferred as it indicates thermoregulatory mechanisms are effective for the participant.

  Baseline (0 min) and end of thermal challenge (120 min) will be compared

Secondary Outcomes (2)

• Core Body Temperature (Tcore) Change

  Baseline (0 min) and end of thermal challenge (120 min) will be compared in persons with Hi-SCI

• Thermal Comfort (TC) Change

  Baseline (0 min) and end of thermal challenge (120 min) will be compared in persons with Hi-SCI

Study Arms (3)

Arm 1: Cooling Vest

EXPERIMENTAL

Phase 1: 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 thermal sensation of their skin beneath the cooling vest.

Device: Cooling Vest

Arm 2: Cooling Vest

EXPERIMENTAL

Phase 2: Participants with Hi-SCI will wear the wet vest (experimental 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.

Device: Cooling Vest

Arm 3: No Vest

NO INTERVENTION

Phase 2: Participants with Hi-SCI will wear 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.

Interventions

Cooling Vest DEVICE

A self-regulating cooling vest for persons 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 a controlled exposure to a warm environment. The vest is an article of clothing, is made of commercially-available "wicking" material, which once saturated with water, uses evaporation to dissipate heat. Channels embedded in the vest supply cooled water to keep the wet vest cool. The cooling capacity of the vest is regulated by a microprocessor which continuously receives feedback from the user's skin and core temperature. The vest is non-invasive and supplies no energy to the user.

Also known as: Novel Cooling Vest

Arm 1: Cooling Vest; Arm 2: Cooling Vest

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

Related Links

• Spinal Cord Damage Research Center

MeSH Terms

Conditions

Spinal Cord Injuries; Hyperthermia

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; Heat Stress Disorders

Results Point of Contact

• Title: Dr. John Handrakis
• Organization: Spinal Cord Damage research Center, James J. Peters VA Medical Center

john.handrakis@va.gov

(718) 584-9000

Study Officials

• John Philip Handrakis, PT DPT EdD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: After the cooling vest has been fully bench-tested, two phases (AB safety; SCI efficacy) will be performed. Phase 1 (Safety): Descriptive design: because persons with SCI have impaired sensation, one group of able-bodied (AB) participants will wear the wet "smart" cooling vest during a heat challenge (sitting in a warm room) to determine its safety. Phase 2 (Efficacy): 1 x 2 Repeated Measures design: one group of persons with Hi-SCI will undergo 2 heat challenges (sitting in a warm room) under 2 conditions (experimental: wet vest, control: no vest) in random order to determine efficacy of the cooling vest in maintaining Tcore and thermal comfort..

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 1, 2022
• Study Start: December 18, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 30, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)