Cooling Vest for Hyperthermia in Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Ian A Paez, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cardiovascular, Kidney, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a "smart" cooling vest for individuals with spinal cord injuries above the 6th thoracic vertebrae (Hi-SCI) who struggle to maintain normal body temperature in warm environments. Researchers will first test the vest on able-bodied individuals to assess safety and comfort, then on those with Hi-SCI to evaluate effectiveness. The goal is to determine if the vest can reduce overheating and improve comfort and quality of life in hot weather. Individuals who have had a spinal cord injury for over a year and experience discomfort in warm temperatures may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily life for those with spinal cord injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you should avoid caffeine and alcohol, and maintain normal salt and water intake for 24 hours before the study.

What prior data suggests that this cooling vest is safe for use in humans?

Research shows that cooling vests, like the one under testing, can help manage body temperature in people with spinal cord injuries. However, some studies suggest these vests might not significantly reduce the increase in core temperature during exercise for athletes, regardless of spinal cord injuries. This indicates that while the vests might not completely prevent body heating, they can enhance comfort.

Regarding safety, the cooling vest being tested is lightweight and uses a safe electrical method to cool the body. It is generally well-tolerated and should not cause harm when used as directed. Since this trial is in the early stages for this specific vest, initial testing will occur on individuals without spinal cord injuries to ensure comfort and safety before use by those with spinal cord injuries.

In summary, while cooling vests are generally safe, their effectiveness can vary. This trial aims to improve the vest's design to enhance both safety and comfort for those most affected by heat. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cooling vest for hyperthermia in spinal cord injury patients because it offers a non-invasive method to manage body temperature. Unlike traditional treatments that often involve medications or environmental adjustments, this vest directly cools the body by being worn in a warm setting, providing immediate relief. It is designed to enhance thermal comfort and may improve the quality of life for those with limited ability to regulate their body temperature due to spinal cord injuries. By focusing on direct cooling through wearable technology, this method could offer a more convenient and targeted approach compared to existing options.

What evidence suggests that this cooling vest is effective for hyperthermia in spinal cord injury?

Research has shown that cooling vests can help control body temperature in people with spinal cord injuries. One study found that these vests lowered body temperature in athletes, regardless of spinal cord injuries. Another study suggested that cooling vests might prevent overheating by slowing the rise in body temperature in hot conditions. In this trial, participants will join different groups to evaluate the cooling vest's effectiveness. Although researchers have not widely tested these vests in people with severe spinal cord injuries, early results are promising. If effective, cooling vests could help prevent overheating and make warm conditions more comfortable. ^{1 2 3 6 7}

Who Is on the Research Team?

John Philip Handrakis, PT DPT EdD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with spinal cord injuries above the 6th thoracic vertebrae and have had their condition for over a year. It's also open to able-bodied people of similar age as controls. Participants should not have cardiovascular, kidney, or severe thyroid diseases; traumatic brain injury; acute illness; be pregnant; or have certain other medical conditions.

Inclusion Criteria

I have had a spinal cord injury for over a year.

I am within 5 years of age of the patient and do not have any disabilities.

You need to drink normal amounts of water and salt, and avoid caffeine, alcohol, and intense exercise for a day before the study.

Exclusion Criteria

You are having a magnetic resonance imaging (MRI) scan while the telemetry capsule is inside your body.

I have broken, inflamed, or fragile skin.

I have had a moderate to severe brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prototype Development and Bench Testing

Development of the 2nd prototype of the cooling vest and bench testing for safety criteria

4-6 weeks

Safety Testing in Able-bodied Participants

Able-bodied participants wear the cooling vest at maximal settings for 2 hours in a warm thermal chamber to assess safety and comfort

2 hours

1 visit (in-person)

Efficacy Testing in Participants with Hi-SCI

Participants with Hi-SCI wear the cooling vest or no vest in a warm thermal chamber for up to 2 hours to assess efficacy in maintaining core body temperature and thermal comfort

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cooling Vest

Trial Overview The study is testing a 'smart' cooling vest designed to help persons with high-level spinal cord injuries regulate their body temperature in warm environments. The goal is for the vest to reduce core body temperature increases by at least half during heat exposure.

How Is the Trial Designed?

Group I: Arm 2: Cooling Vest Experimental Treatment 1 Intervention

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.

Group II: Arm 1: Cooling Vest Experimental Treatment 1 Intervention

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.

Group III: Arm 3: No Vest Active Control 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Local cooling methods, such as an ice-packet vest and a refrigerated headpiece, were tested on six elite wheelchair athletes in a hot-humid environment, but they did not significantly reduce heat strain during strenuous exercise.

Despite the cooling methods providing some potential cooling power, they were ineffective in preventing heat storage in the body, indicating that local cooling may not be a reliable strategy for managing heat strain in wheelchair athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local cooling in wheelchair athletes during exercise-heat stress. Armstrong, LE., Maresh, CM., Riebe, D., et al.[2008]

Pre-cooling with an ice vest, combined with water sprays during play, significantly reduces thermal strain in athletes with tetraplegia compared to no cooling, as indicated by lower skin temperatures.

However, this cooling strategy does not improve performance or perceptual responses during simulated wheelchair rugby, suggesting that while it helps manage heat, it doesn't enhance athletic output.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cooling before and during simulated match play on thermoregulatory responses of athletes with tetraplegia. Griggs, KE., Havenith, G., Paulson, TAW., et al.[2022]

A study involving 16 participants tested three different cooling vests and found that using these vests before and after exercise significantly reduced core and skin temperatures, with reductions of approximately 0.5°C for rectal temperature and 0.1-1.4°C for abdominal skin temperature.

The cooling vests also improved endurance performance, increasing running times at high intensity by up to 49 seconds, while participants reported greater satisfaction regarding their thermal comfort and skin wetness during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A light-weight cooling vest enhances performance of athletes in the heat. Webster, J., Holland, EJ., Sleivert, G., et al.[2006]

Pre-cooling significantly reduces core temperature (Tc) more effectively than per-cooling in individuals with spinal cord injuries, which is crucial for preventing heat-related illnesses during exercise.

Both pre- and per-cooling methods effectively lower core and skin temperatures, as well as thermal sensation, with greater benefits observed in individuals with tetraplegia, highlighting the importance of cooling strategies for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of pre-cooling or per-cooling in athletes with a spinal cord injury: A systematic review and meta-analysis. O'Brien, TJ., Lunt, KM., Stephenson, BT., et al.[2022]

The study developed a bioheat model to evaluate the effectiveness of personal cooling vests for individuals with paraplegia during exercise, showing that these vests can enhance heat loss from the body.

While using cooling vests increased sensible heat loss from the torso, it did not significantly change core temperatures or overall body heat storage, indicating that while cooling vests help, they may not fully prevent heat stress in individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Would personal cooling vest be effective for use during exercise by people with thoracic spinal cord injury? Mneimneh, F., Ghaddar, N., Ghali, K., et al.[2019]

In a study involving seven paraplegic athletes, the use of a spray bottle for evaporative cooling during rest breaks did not significantly affect heat storage or performance during high-intensity arm exercise.

Despite the application of mist, there were no notable differences in skin temperature, rectal temperature, or perceived exertion compared to control conditions, indicating that the spray bottle was ineffective in reducing heat strain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of artificial sweat in athletes with spinal cord injuries. Pritchett, RC., Bishop, PA., Yang, Z., et al.[2022]

A prototype neck cooling system was developed to prevent heatstroke in individuals with cervical spinal cord injuries, utilizing a refrigerated circulator and thermoplastic films for effective heat transfer.

Testing on two unimpaired participants in a hot environment showed that the cooling system significantly reduced sweating and helped maintain lower skin and core temperatures compared to no cooling, demonstrating its potential efficacy in heat management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Construction of a soft wearable body cooling system for persons with spinal cord injury. Takashima, A., Sato, K., Takizawa, K., et al.[2020]

In a study involving three participants with varying degrees of spinal cord injury (SCI) and one without, it was found that core temperature (TC) rose the most in individuals with complete tetraplegia during exercise in high heat, highlighting the impact of neurological injury on thermoregulation.

Among the cooling interventions tested, water spray (WS) was the most effective in reducing TC rise during exercise in heat for those with SCI, suggesting it could be a valuable strategy for preventing hyperthermia in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Various Cooling Techniques During Exercise in Persons With Spinal Cord Injury: A Pilot Crossover Intervention Study. Trbovich, M.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6368108/

Efficacy of Various Cooling Techniques During Exercise in ... Effect of a cooling vest on core temperature in athletes with and without spinal cord injury. Top Spinal Cord Inj Rehabil. 2014;20(1):70–80. doi: 10.1310 ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/49/NCT05441449/Prot_SAP_001.pdf

Development of a Novel Cooling Vest to Prevent Heat- ... If the self- regulating cooling vest proves to be an effective treatment for maintenance of Tcore during warm temperature exposure in this study, it or a ...

3. jsams.org jsams.org/article/S1440-2440(22)00039-1/fulltext

The effect of pre-cooling or per-cooling in athletes with a ... Pre-cooling may reduce T c to a greater extent than per-cooling during subsequent exercise. Pre- and per-cooling can attenuate the increase in thermal strain.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306456519300154

Would personal cooling vest be effective for use during ... Would personal cooling vest be effective for use during exercise by people with thoracic spinal cord injury? · Problem statement · Modelling methodology.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3919696/

Effect of a Cooling Vest on Core Temperature in Athletes With ... TP athletes have the highest risk of exercise-induced hyperthermia. The cooling vest does not significantly attenuate rise in T c in SCI or AB athletes.

6. ctv.veeva.com ctv.veeva.com/study/a-novel-cooling-vest-to-protect-persons-with-sci-from-hyperthermia

A Novel Cooling Vest to Protect Persons With SCI From ... 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 ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/49/NCT05441449/ICF_000.pdf

Development of a Novel Cooling Vest to Prevent Heat- ... Development of a Novel Cooling Vest to Prevent. Heat-Induced Thermoregulatory Dysfunction in. Persons with Spinal Cord Injury. NCT05441449. September 7, 2023 ...