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Cooling Vest for Hyperthermia in Spinal Cord Injury

N/A

Waitlist Available

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 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.

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

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,588 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

Cooling Vest (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05441449 — N/A

Spinal Cord Injury Research Study Groups: Arm 2: Cooling Vest, Arm 1: Cooling Vest, Arm 3: No Vest

Spinal Cord Injury Clinical Trial 2023: Cooling Vest Highlights & Side Effects. Trial Name: NCT05441449 — N/A

Cooling Vest (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05441449 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must potential participants fulfill in order to join this trial?

"Aspiring patients of this medical trial should possess a spinal cord injury and be within the age range of 18 to 68. Fifteen people are anticipated to take part in this research endeavour."

Answered by AI

Are there still spots available for enrolment in the trial?

"According to the information available at clinicaltrials.gov, no new patients are currently being recruited for this medical trial which was first made public on February 13th 2023 and last updated August 1st 2022. However, there are currently 428 other investigations looking for volunteers."

Answered by AI