Cooling Vest for Hyperthermia in Spinal Cord Injury

Overseen by John Philip Handrakis, PT DPT EdD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

Disqualifiers: Cardiovascular, Kidney, Diabetes, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a special cooling vest designed for people with severe spinal cord injuries who struggle to stay cool in warm weather. The vest works by absorbing and evaporating body heat to prevent overheating. The goal is to improve comfort and safety for these individuals during hot conditions. Cooling vests have been studied for their effectiveness in reducing heat strain and improving thermal comfort in various populations, including athletes and construction workers.

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 data supports the effectiveness of the treatment Cooling Vest for Hyperthermia in Spinal Cord Injury?

Research shows that cooling interventions, like water sprays and ice vests, can help manage body temperature in people with spinal cord injuries during exercise in hot conditions. While cooling vests alone may not significantly reduce core temperature, they can increase heat loss from the body, which might help in managing heat stress. ^{1 2 3 4 5}

Is the cooling vest safe for humans?

The studies on cooling vests, including those used by athletes with spinal cord injuries, do not report any safety concerns, suggesting they are generally safe for human use. ^{1 2 3 6 7}

How does the cooling vest treatment for hyperthermia in spinal cord injury differ from other treatments?

The cooling vest treatment is unique because it provides a wearable solution that directly cools the body, potentially reducing heat stress by using phase change materials or ice, which is different from other methods like water sprays or ice slurry ingestion that are not wearable. ^{1 2 3 5 8}

Research Team

John Philip Handrakis, PT DPT EdD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Cooling Vest (Other)

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.

Participant Groups

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+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Local cooling in wheelchair athletes during exercise-heat stress. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. Australia pubmed.ncbi.nlm.nih.gov

Effects of cooling before and during simulated match play on thermoregulatory responses of athletes with tetraplegia. [2022]

4. Australia 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Would personal cooling vest be effective for use during exercise by people with thoracic spinal cord injury? [2019]

6. England pubmed.ncbi.nlm.nih.gov

A light-weight cooling vest enhances performance of athletes in the heat. [2006]

7. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of artificial sweat in athletes with spinal cord injuries. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Construction of a soft wearable body cooling system for persons with spinal cord injury. [2020]