Heated Vest for Persons With Spinal Cord Injury

NCT03662308 | Completed Results FDA Device

• 2 other identifiers: B2884-P1I21RX002884-01A1
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Hypothermia; Body Temperature Regulation; Cognition

Outcome Measures

Primary Outcomes (4)

• Change in Core Body Temperature (Tcore)

  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.

  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.

• Change in Cognitive Performance: WAIS-IV (Wechsler Adult Intelligence Scale-Fourth Edition)

  WAIS-IV Digit Span test has 3, 16-point sections (Forward, Backward, Sequence) and assesses attention, processing speed, and working memory. Cognitive battery is administered at BL, after Thermal Challenge (tetra only). Testing conditions are distraction-free. The Forward section has 16 numerical sequences of successive increasing length (each 1 point). Participant is read the numbers, then asked to repeat the test numbers in the same order. In Backward, participant is asked to repeat the numbers in reverse order. In Sequence portion, the participant is asked to repeat the numbers in ascending order. Sections add to a WAIS-IV Total Score of 48. The greater the score, the better the cognitive function. The minimum score, which would represent not being able to repeat even the first sequence of numbers, is 0. We report the difference in WAIS-IV score before and after the cold challenge. The more negative the difference, the more cognitive impairment after cold challenge.

  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. Each WAIS is 10 min

• Change in Cognitive Performance: Delayed Recall

  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. In scoring the MoCA, one point is awarded for each of the five words. Thus, the score ranges from 0 (no words remembered) to 5 (all words remembered). A higher score represents a more intact delayed recall capacity. We administered the Delayed Recall of the MoCA before and after the cold challenge, in both the heated vest (powered) and non-heated vest control condition. The reported measure is the mean difference in MoCA Delayed Recall scores before and after the cold challenge. Here, a more negative number represents a greater degree of impairment in delayed recall (working memory) after the cold challenge.

  Visits 2 & 3 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. Each assessment requires 6 min.

• Change in Cognitive Performance: Stroop

  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). Each assessment is 4 min. The Stroop Test yields three scores. The Raw Word score is the number of words correctly completed on the Word page in 45 seconds. Similarly for Color, and Color-Word. For example, in the color-word section, a participant correctly identifying the color of 61 words, the score is 61. Greater scores reflects greater executive functioning. Zero is the minimum score, which corresponds to not being able to read any of the words of colors or colors of fonts. Each words of colors or color of fonts correctly identified in time confer 1 point. We report the difference in Word-Color before the cold challenge and after the cold challenge, for each intervention. Negative differences represent impaired executive function.

  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.

Secondary Outcomes (1)

• Change in Thermal Comfort (TC)

  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.

Other Outcomes (2)

• Change in Skin Temperature (Tsk) Under the Heated Vest

  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.

• Change in Thermal Sensation (TS)

  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.

Study Arms (3)

Heated Vest Safety & Comfort (able-bodied subjects)

OTHER

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 Efficacy (persons with tetraplegia)

EXPERIMENTAL

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

Non-Heated Vest control condition (persons with tetraplegia)

ACTIVE COMPARATOR

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

Interventions

Heated Vest DEVICE

Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature

Also known as: Feedback-controlled heated vest

Heated Vest Efficacy (persons with tetraplegia); Heated Vest Safety & Comfort (able-bodied subjects)

Non-Heated Vest DEVICE

A similarly insulated (compared to the experimental vest), but non-heated vest

Also known as: Active comparator vest, control condition

Non-Heated Vest control condition (persons with tetraplegia)

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• United States Military Academy West Point: collaborator

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

Related Publications (1)

• Zhang H, Huizenga C, Arens E, Wang D. Thermal sensation and comfort in transient non-uniform thermal environments. Eur J Appl Physiol. 2004 Sep;92(6):728-33. doi: 10.1007/s00421-004-1137-y.

  PMID: 15221406 BACKGROUND

Related Links

• Spinal Cord Damage Research Center

MeSH Terms

Conditions

Spinal Cord Injuries; Hypothermia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. John Handrakis
• Organization: SPINAL CORD DAMAGE RESEARCH CENTER

john.handrakis@va.gov

718.584.9000

Study Officials

• John Philip Handrakis, PT DPT EdD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: September 7, 2018
• Study Start: February 25, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: May 6, 2024
• Results First Posted: February 1, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)