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Heated Vest for Persons With Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662308
Recruitment Status : Active, not recruiting
First Posted : September 7, 2018
Last Update Posted : August 6, 2020
Sponsor:
Collaborator:
United States Military Academy
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Persons with higher levels of spinal cord injury (above the 2nd thoracic vertebrae; tetraplegia) are unable to maintain normal core body temperature (Tcore) when exposed to cool environments. In persons with tetraplegia, even limited exposure to cool temperatures may cause Tcore to approach hypothermic values and impair cognitive performance. Conversely, an increase in Tcore from subnormal to normal range may improve cognitive performance. Prior work has shown that cool seasonal temperatures have an adverse effect on personal comfort and the ability to perform vital daily activities of self-care in persons with tetraplegia. Interventions that address the vulnerability to hypothermia are limited. A self-regulating heated vest designed specifically for persons with tetraplegia is a novel and promising strategy to address this problem. By more effectively maintaining Tcore, the vest can decrease the adverse impact of cool temperatures on comfort, quality of life, and performance of vital daily tasks for Veterans with tetraplegia during the cooler seasons.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Heated Vest Device: Non-Heated Vest Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

After the heated vest has 1) been fully bench-tested and 2) satisfied safety and tolerability testing in able-bodied subjects, it will be tested in persons with tetraplegia using a crossover design with the order of the two visits randomized.

  1. Thermal Challenge with heated vest (subjects with tetraplegia only): Subjects with tetraplegia, while seated and wearing only a standard T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest.
  2. Thermal Challenge with non-heated vest (subjects with tetraplegia only): The same subjects with tetraplegia (from Visit 2), while seated and wearing only a standard T-shirt and shorts, will be fitted with an appropriately sized, similar, but non-heated vest. Subjects will be transferred to a pre-cooled thermal chamber and data will be collected for up to 2 hours.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Developing a Feedback-Controlled Heated Vest to Address Thermoregulatory Dysfunction in Persons With Spinal Cord Injury
Actual Study Start Date : February 25, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Heated Vest Safety & Comfort (able-bodied subjects)
Able-bodied controls will be fitted with an appropriately sized heated vest, while wearing only a standard cotton T-shirt and shorts, and will remain seated in a wheelchair. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for 2 hours with the heated vest on full power. Outcome Variables for Visit 1: Skin thermocouple temperatures, subjective ratings of thermal sensation.
Device: Heated Vest
Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature
Other Name: Feedback-controlled heated vest

Experimental: Heated Vest Efficacy (persons with tetraplegia)
Subjects with tetraplegia, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized heated vest. Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the self-regulating heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort.
Device: Heated Vest
Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature
Other Name: Feedback-controlled heated vest

Active Comparator: Non-Heated Vest control condition (persons with tetraplegia)
The same subjects with tetraplegia from the experimental arm, while seated and wearing only a standard cotton T-shirt and shorts, will be fitted with an appropriately sized, similarly insulated, but non-heated vest (control condition). Subjects will be transferred to a pre-cooled (18 degrees C) thermal chamber and data will be collected for up to 2 hours with the non-heated vest. Primary Dependent variables: core body temperature (Tcore), cognitive performance, and thermal comfort.
Device: Non-Heated Vest
A similarly insulated (compared to the experimental vest), but non-heated vest
Other Name: Active comparator vest, control condition




Primary Outcome Measures :
  1. Change in Core Body Temperature (Tcore) [ Time Frame: Visits 2 & 3 (subjects with tetraplegia only): Continuously throughout baseline & Thermal Challenge (2 hrs) periods. The change in Tcore from baseline to the end of Thermal Challenge will be determined. ]
    Tcore will be continuously monitored throughout baseline and thermal challenge periods (with heated & non-heated vests) by a TX-2 Rectal probe and Iso-Thermex Multichannel Thermometer (Columbus Instruments, Columbus, OH). The probe will be placed 10 cm beyond the anal sphincter.

  2. Change in Cognitive Performance: WAIS-IV [ Time Frame: Visits 2 & 3 (subjects with tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined. ]

    The cognitive battery will be administered once at BL and once after Thermal Challenge in persons with tetraplegia only (Visits 2 & 3). Testing conditions will be identical, quiet, and distraction-free. Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV): Subjects will be asked to repeat 2-9 numbers forward, backward and in ascending order to assess attention, processing speed, and working memory.

    Each assessment requires 10 min.


  3. Change in Cognitive Performance: Delayed Recall [ Time Frame: Visits 2 & 3 (subjects with tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined. ]

    Delayed Recall section of the Montreal Cognitive Assessment (MoCA): Subjects will be asked to repeat 5 simple words immediately and then recall them after a 5-minute delay to assess working memory.

    Each assessment requires 6 min.


  4. Change in Cognitive Performance: Stroop [ Time Frame: Visits 2 & 3 (subjects with tetraplegia only): At the end baseline (at 15 min) & end of Thermal Challenge (at 120 min) periods. The change in cognitive performance from baseline to the end of Thermal Challenge will be determined. ]

    Stroop Color and Word: Subjects will be asked to read words of colors, colors of fonts to assess attention and processing speed; color of fonts of words which describe conflicting colors to assess response inhibition (executive functioning). Subjects will practice each of the assessments for approximately 10 seconds prior to the actual test to ensure understanding of the instructions.

    Each assessment requires 4 min.



Secondary Outcome Measures :
  1. Change in Thermal Comfort (TC) [ Time Frame: Visits 1, 2, & 3 (all subjects): During baseline & every 10 minutes throughout Thermal Challenge (2 hrs). The change in TC from baseline to the end of Thermal Challenge will be determined. ]

    Thermal Comfort will be measured every 10 minutes throughout BL and thermal challenge periods by the Zhang 6-point thermal comfort scale: +3 (very comfortable), +2 (comfortable), +1 (just comfortable), -1 (just uncomfortable), -2 (uncomfortable), and -3 (very uncomfortable). A greater frequency of +1, +2, and +3 scores are considered more desirable than -1, -2, and -3 scores during the Thermal Challenge.

    Each assessment requires only the time needed for the subject to respond (typically less than 10 seconds).



Other Outcome Measures:
  1. Change in Skin Temperature (Tsk) under the heated vest [ Time Frame: Visits 2 & 3 (all subjects): Continuously throughout baseline (15 min) & Thermal Challenge (2 hrs) periods. The change in Tsk from baseline to the end of Thermal Challenge will be determined. ]
    Skin thermocouples (TX-4 Skin Surface probes, Columbus Instruments, Columbus, OH) will be taped to 12 sites on the anterior trunk. Tsk data will be collected continuously throughout the baseline (BL) and Thermal Challenge periods. All areas under the vest will have skin temperatures less than or equal to 39 degrees C.

  2. Change in Thermal Sensation (TS) [ Time Frame: Visit 1 (able-bodied subjects only): During baseline & every 10 minutes throughout Thermal Challenge (2 hrs). The change in TS from baseline to the end of Thermal Challenge will be determined. ]

    Thermal sensation will be measured on the Zhang 9-point Thermal Sensation scale: +4 (very hot), +3 (hot), +2 (warm), +1 (slightly warm), 0 (neutral), -1 (slightly cool), -2 (cool), -3 (cold), and -4 (very cold). TS should be no greater than "warm" this would include identification of "hot spots".

    Each assessment requires only the time needed for the subject to respond (typically less than 10 seconds).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects with spinal cord injury (SCI) and able-bodied subjects will be recruited according to the following criteria:

  • Duration of injury 1 year
  • Neurological Level of SCI [C3-T1]; American Spinal Injury Association (ASIA) Impairment Scale (AIS) A & B
  • Euhydration

    • Subjects will be instructed to avoid caffeine and alcohol
    • maintain normal salt and water intake
    • avoid strenuous exercise for 24 hours prior to study

Exclusion Criteria:

  • Known heart, kidney, peripheral vascular or cerebrovascular disease
  • High blood pressure
  • History of Traumatic Brain Injury (TBI) or diagnosed cognitive impairment
  • Untreated thyroid disease
  • Diabetes mellitus
  • Acute illness or infection
  • Dehydration
  • Smoking
  • Pregnant women
  • BMI>30 kg/m2
  • Broken, inflamed, or otherwise fragile skin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662308


Locations
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United States, New York
James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
United States Military Academy
Investigators
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Principal Investigator: John Philip Handrakis, PT DPT EdD James J. Peters Veterans Affairs Medical Center
Additional Information:
Publications:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03662308    
Other Study ID Numbers: B2884-P
1I21RX002884-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Hypothermia
Body Temperature Regulation
Cognition
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System