What is the mechanism of action of this treatment?

Common treatments for Spinal Cord Injury (SCI) include interventions that help manage body temperature, such as the Smart Cooling Vest, which dissipates body heat to prevent hyperthermia. This is crucial for patients with high-level SCI (above the 6th thoracic vertebrae) who cannot regulate their core body temperature effectively. Other treatments include physical therapy to improve mobility and strength, functional electrical stimulation to enhance muscle function, and pharmacologic treatments targeting pain and spasticity. These treatments are essential for improving the quality of life, preventing complications, and enabling participation in daily activities for SCI patients.

What side effects are associated with this type of intervention?

Treatments for Spinal Cord Injury (SCI) that involve temperature regulation, such as the Smart Cooling Vest designed to prevent hyperthermia, can have side effects similar to those seen in scalp hypothermia used in chemotherapy. Common side effects include discomfort from feeling cold, headaches, scalp pain, neck pain, and a sensation of heaviness in the head. These side effects are typically mild and manageable.

What prior FDA approvals exist?

There are no specific FDA-approved treatments mentioned for spinal cord injury that are similar to the Smart Cooling Vest, which focuses on dissipating body heat to prevent hyperthermia. Generally, FDA-approved treatments for SCI include pharmacologic therapies, surgical interventions, and physical rehabilitation programs aimed at improving functional outcomes and managing complications. Cooling devices specifically designed for SCI patients to manage body temperature are still under investigation and have not yet received FDA approval.

What other types of research exist?

Promising alternatives to the Smart Cooling Vest for SCI patients may include: 1) Fan Cooling Jackets, which have shown effectiveness in reducing skin and core temperatures during and after exercise in hot environments. 2) Advanced thermoregulatory textiles, which can provide personalized and adaptive cooling through smart fabric technology. These alternatives could offer effective ways to manage body temperature and prevent hyperthermia in SCI patients.

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Cooling Vest for Hyperthermia in Spinal Cord Injury

N/A

Recruiting

Led By John Philip Handrakis, PT DPT EdD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Spinal cord injury (SCI) >1 year in duration

Gender and age-matched (±5 years) able-bodied (AB) controls

Must not have

Broken, inflamed, or otherwise fragile skin

Traumatic brain injury (mod-severe)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (0 min) and end of thermal challenge (120 min) will be compared

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, potential risks may include skin irritation from wearing the vest, discomfort due to cold temperatures, and possible malfunctioning of the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My spinal cord injury is between C4 and T2 and is classified as severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have broken, inflamed, or fragile skin.

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I have had a moderate to severe brain injury.

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I have a blockage in my digestive system.

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I am currently experiencing an acute illness or infection.

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I have a heart, kidney, or untreated thyroid condition.

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I have diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (0 min) and end of thermal challenge (120 min) will be compared

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (0 min) and end of thermal challenge (120 min) will be compared

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0 min) and end of thermal challenge (120 min) will be compared for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Skin temperature (Tsk) change

Thermal Sensation (TS) change

Secondary study objectives

Core body temperature (Tcore) change

Thermal comfort (TC) change

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2: Cooling VestExperimental Treatment1 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 VestExperimental Treatment1 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 VestActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cooling Vest

2017

N/A

~40

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Spinal Cord Injury (SCI) include interventions that help manage body temperature, such as the Smart Cooling Vest, which dissipates body heat to prevent hyperthermia. This is crucial for patients with high-level SCI (above the 6th thoracic vertebrae) who cannot regulate their core body temperature effectively. Other treatments include physical therapy to improve mobility and strength, functional electrical stimulation to enhance muscle function, and pharmacologic treatments targeting pain and spasticity. These treatments are essential for improving the quality of life, preventing complications, and enabling participation in daily activities for SCI patients.

Overview of Cochrane Systematic Reviews for Rehabilitation Interventions in Persons With Spinal Cord Injury: A Mapping Synthesis.Physical therapy treatment of a pediatric patient with symptoms consistent with a spinal cord injury without radiographic abnormality: A retrospective case report.No Difference Between Noxious and Innocuous Thermal Stimulation on Motor Recovery of Upper Extremity in Patients With Acute Stroke: A Randomized Controlled Trial With 6-Month Follow-up.