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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 min) and end of thermal challenge (120 min) will be compared
Awards & highlights
Study Summary
This trial is testing a "smart" cooling vest that will help people with high spinal cord injuries keep their core temperature within a normal range when exposed to warm temperatures.
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.Check my eligibility
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.See study design
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 belowSelect...
I have had a spinal cord injury for over a year.
Select...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Skin temperature (Tsk) change
Thermal Sensation (TS) change
Secondary outcome measures
Core body temperature (Tcore) change
Thermal comfort (TC) change
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
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.
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.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,621 Previous Clinical Trials
3,323,486 Total Patients Enrolled
John Philip Handrakis, PT DPT EdDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
2 Previous Clinical Trials
58 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a spinal cord injury for over a year.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.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.I have a blockage in my digestive system.I am currently experiencing an acute illness or infection.Participants who smoke and have spinal cord injury will be excluded from the study.You have a heart pacemaker or another implanted electrical device.I have a heart, kidney, or untreated thyroid condition.I have diabetes.You have a body mass index (BMI) higher than 30.My spinal cord injury is between C4 and T2 and is classified as severe.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Cooling Vest
- Group 2: Arm 1: Cooling Vest
- Group 3: Arm 3: No Vest
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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