Spinal Cord Injuries Clinical Trial
Official title:
Development of a Novel Cooling Vest to Prevent Heat-Induced Thermoregulatory Dysfunction in Persons With Spinal Cord Injury
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | October 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 68 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | James J. Peters VA Medical Center, Bronx, NY | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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). | Baseline (0 min) and end of thermal challenge (120 min) will be compared | |
Secondary | Core body temperature (Tcore) change | Tcore: will be monitored by an ingestible telemetry capsule, CorTemp (HQ Inc, Palmetto, Fla) in persons with Hi-SCI only. Less of an increase in Tcore is considered desirable during the thermal challenge. | Baseline (0 min) and end of thermal challenge (120 min) will be compared in persons with Hi-SCI | |
Secondary | Thermal comfort (TC) change | TC will be measured by a 6-point thermal comfort scale (+3 Very Comfortable, +2 Comfortable, +1 Just Comfortable, -1 Just Uncomfortable, -2 Uncomfortable, -3 Very Uncomfortable). Scores of +1, +2, and +3 scores are considered more desirable than -1, -2, and -3 scores during the thermal challenge. | Baseline (0 min) and end of thermal challenge (120 min) will be compared in persons with Hi-SCI |
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