Status:
COMPLETED
A Novel Cooling Vest to Protect Persons With SCI From Hyperthermia
Lead Sponsor:
VA Office of Research and Development
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-68 years
Phase:
NA
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 expos...
Detailed Description
Problem Statement: Loss of supraspinal control of autonomic pathways interrupts homeostasis of multiple organ systems including thermoregulation. Thermoregulatory mechanisms are dysfunctional due to i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05441449
Start Date
December 18 2023
End Date
January 31 2025
Last Update
April 30 2025
Active Locations (1)
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1
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States, 10468-3904