Heated Vest for Persons With Spinal Cord Injury
NCT03662308, Not applicable, Completed, VA Office of Research and Development; results first posted 2024-02-01
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Heated Vest for Persons With Spinal Cord Injury | ClinicalTrials.gov |
| NCT number | NCT03662308 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 17 participants, actual | ClinicalTrials.gov |
| Lead sponsor | VA Office of Research and Development | ClinicalTrials.gov |
| Conditions | Spinal Cord Injuries | ClinicalTrials.gov |
| Interventions | Heated Vest, Non-Heated Vest | ClinicalTrials.gov |
| First posted | 2018-09-07 | ClinicalTrials.gov |
| Last updated | 2024-05-06 | ClinicalTrials.gov |
| Results first posted | 2024-02-01 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Core Body Temperature (Tcore) | 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. | ClinicalTrials.gov |
| Primary | Change in Cognitive Performance: WAIS-IV (Wechsler Adult Intelligence Scale-Fourth Edition) | 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 | 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. | ClinicalTrials.gov |
| Primary | Change in Cognitive Performance: Delayed Recall | 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. | 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. | ClinicalTrials.gov |
| Primary | Change in Cognitive Performance: Stroop | 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). 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. | ClinicalTrials.gov |
| Secondary | 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. | 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). | ClinicalTrials.gov |
| Other | 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. | 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. | ClinicalTrials.gov |
| Other | 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. | 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). | ClinicalTrials.gov |
Outcomes 7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change in Core Body Temperature (Tcore) | 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 measurement was not performed in able-bodied participants. | Degrees Celsius | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Cognitive Performance: WAIS-IV (Wechsler Adult Intelligence Scale-Fourth Edition) | 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 | We did not administer the Wechsler Adult Intelligence Scale Test to able-bodied participants. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Cognitive Performance: Delayed Recall | 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. | We did not measure working memory in able bodied participants. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change in Cognitive Performance: Stroop | 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. | We did not measure cognitive performance in able bodied participants. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | 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. | score on a scale | MEAN | ClinicalTrials.gov | |
| OTHER_PRE_SPECIFIED | 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. | Degrees Celcius | MEAN | ClinicalTrials.gov | |
| OTHER_PRE_SPECIFIED | 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. | We did not collect Thermal Sensation in persons with tetraplegia; we only collected this outcome measure in able-bodied controls. | units on a scale | MEAN | ClinicalTrials.gov |
Results by group 15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change in Core Body Temperature (Tcore) | Heated Vest Efficacy (Persons With Tetraplegia) | -0.22 | Standard Deviation .34 | Degrees Celsius | ClinicalTrials.gov | |
| Change in Core Body Temperature (Tcore) | Non-Heated Vest Control Condition (Persons With Tetraplegia) | -0.46 | Standard Deviation 0.24 | Degrees Celsius | ClinicalTrials.gov | |
| Change in Cognitive Performance: WAIS-IV (Wechsler Adult Intelligence Scale-Fourth Edition) | Heated Vest Efficacy (Persons With Tetraplegia) | -0.500 | Standard Error 0.707 | score on a scale | ClinicalTrials.gov | |
| Change in Cognitive Performance: WAIS-IV (Wechsler Adult Intelligence Scale-Fourth Edition) | Non-Heated Vest Control Condition (Persons With Tetraplegia) | -0.375 | Standard Error 0.460 | score on a scale | ClinicalTrials.gov | |
| Change in Cognitive Performance: Delayed Recall | Heated Vest Efficacy (Persons With Tetraplegia) | -0.38 | Standard Deviation 0.74 | score on a scale | ClinicalTrials.gov | |
| Change in Cognitive Performance: Delayed Recall | Non-Heated Vest Control Condition (Persons With Tetraplegia) | -2.00 | Standard Deviation 1.8 | score on a scale | ClinicalTrials.gov | |
| Change in Cognitive Performance: Stroop | Heated Vest Efficacy (Persons With Tetraplegia) | -2.125 | Standard Error 1.302 | score on a scale | ClinicalTrials.gov | |
| Change in Cognitive Performance: Stroop | Non-Heated Vest Control Condition (Persons With Tetraplegia) | -1.750 | Standard Error 1.590 | score on a scale | ClinicalTrials.gov | |
| Change in Thermal Comfort (TC) | Heated Vest Safety & Comfort (Able-bodied Subjects) | 0.031 | Standard Deviation .72 | score on a scale | ClinicalTrials.gov | |
| Change in Thermal Comfort (TC) | Heated Vest Efficacy (Persons With Tetraplegia) | -1.04 | Standard Deviation 1.51 | score on a scale | ClinicalTrials.gov | |
| Change in Thermal Comfort (TC) | Non-Heated Vest Control Condition (Persons With Tetraplegia) | -0.96 | Standard Deviation 1.12 | score on a scale | ClinicalTrials.gov | |
| Change in Skin Temperature (Tsk) Under the Heated Vest | Heated Vest Safety & Comfort (Able-bodied Subjects) | 3.79 | Standard Deviation 1.26 | Degrees Celcius | ClinicalTrials.gov | |
| Change in Skin Temperature (Tsk) Under the Heated Vest | Heated Vest Efficacy (Persons With Tetraplegia) | 4.64 | Standard Deviation 1.20 | Degrees Celcius | ClinicalTrials.gov | |
| Change in Skin Temperature (Tsk) Under the Heated Vest | Non-Heated Vest Control Condition (Persons With Tetraplegia) | 0.77 | Standard Deviation 0.42 | Degrees Celcius | ClinicalTrials.gov | |
| Change in Thermal Sensation (TS) | Heated Vest Safety & Comfort (Able-bodied Subjects) | 0.59 | Standard Deviation 0.61 | units on a scale | ClinicalTrials.gov |
Participant flow 18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| First Intervention | STARTED | Heated Vest Safety & Comfort (Able-bodied Subjects) | 8 | ClinicalTrials.gov | |
| First Intervention | STARTED | Persons With Tetraplegia: Heated Vest First, Then Non-Heated Vest | 5 | ClinicalTrials.gov | |
| First Intervention | STARTED | Persons With Tetraplegia: Non-Heated Vest First, Then Heated Vest | 4 | ClinicalTrials.gov | |
| First Intervention | COMPLETED | Heated Vest Safety & Comfort (Able-bodied Subjects) | 8 | ClinicalTrials.gov | |
| First Intervention | COMPLETED | Persons With Tetraplegia: Heated Vest First, Then Non-Heated Vest | 5 | ClinicalTrials.gov | |
| First Intervention | COMPLETED | Persons With Tetraplegia: Non-Heated Vest First, Then Heated Vest | 4 | ClinicalTrials.gov | |
| First Intervention | NOT COMPLETED | Heated Vest Safety & Comfort (Able-bodied Subjects) | 0 | ClinicalTrials.gov | |
| First Intervention | NOT COMPLETED | Persons With Tetraplegia: Heated Vest First, Then Non-Heated Vest | 0 | ClinicalTrials.gov | |
| First Intervention | NOT COMPLETED | Persons With Tetraplegia: Non-Heated Vest First, Then Heated Vest | 0 | ClinicalTrials.gov | |
| Second Intervention (Tetraplegia ONLY) | STARTED | Heated Vest Safety & Comfort (Able-bodied Subjects) | 0 | ClinicalTrials.gov | |
| Second Intervention (Tetraplegia ONLY) | STARTED | Persons With Tetraplegia: Heated Vest First, Then Non-Heated Vest | 5 | ClinicalTrials.gov | |
| Second Intervention (Tetraplegia ONLY) | STARTED | Persons With Tetraplegia: Non-Heated Vest First, Then Heated Vest | 4 | ClinicalTrials.gov | |
| Second Intervention (Tetraplegia ONLY) | COMPLETED | Heated Vest Safety & Comfort (Able-bodied Subjects) | 0 | ClinicalTrials.gov | |
| Second Intervention (Tetraplegia ONLY) | COMPLETED | Persons With Tetraplegia: Heated Vest First, Then Non-Heated Vest | 5 | ClinicalTrials.gov | |
| Second Intervention (Tetraplegia ONLY) | COMPLETED | Persons With Tetraplegia: Non-Heated Vest First, Then Heated Vest | 4 | ClinicalTrials.gov | |
| Second Intervention (Tetraplegia ONLY) | NOT COMPLETED | Heated Vest Safety & Comfort (Able-bodied Subjects) | 0 | ClinicalTrials.gov | |
| Second Intervention (Tetraplegia ONLY) | NOT COMPLETED | Persons With Tetraplegia: Heated Vest First, Then Non-Heated Vest | 0 | ClinicalTrials.gov | |
| Second Intervention (Tetraplegia ONLY) | NOT COMPLETED | Persons With Tetraplegia: Non-Heated Vest First, Then Heated Vest | 0 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 9
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Heated Vest Safety & Comfort (Able-bodied Subjects) | 0 | 8 | ClinicalTrials.gov |
| Total, all-cause mortality | Heated Vest Efficacy (Persons With Tetraplegia) | 0 | 9 | ClinicalTrials.gov |
| Total, all-cause mortality | Non-Heated Vest Control Condition (Persons With Tetraplegia) | 0 | 9 | ClinicalTrials.gov |
| Total, other adverse events | Heated Vest Safety & Comfort (Able-bodied Subjects) | 0 | 8 | ClinicalTrials.gov |
| Total, other adverse events | Heated Vest Efficacy (Persons With Tetraplegia) | 0 | 9 | ClinicalTrials.gov |
| Total, other adverse events | Non-Heated Vest Control Condition (Persons With Tetraplegia) | 0 | 9 | ClinicalTrials.gov |
| Total, serious adverse events | Heated Vest Safety & Comfort (Able-bodied Subjects) | 0 | 8 | ClinicalTrials.gov |
| Total, serious adverse events | Heated Vest Efficacy (Persons With Tetraplegia) | 0 | 9 | ClinicalTrials.gov |
| Total, serious adverse events | Non-Heated Vest Control Condition (Persons With Tetraplegia) | 0 | 9 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 15221406 | BACKGROUND | PubMed |
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| I21RX002884 | Developing a Feedback-Controlled Heated Vest to Address Thermoregulatory Dysfunction in Persons with Spinal Cord Injury | HANDRAKIS, JOHN P | JAMES J PETERS VA MEDICAL CENTER | Veterans Affairs | 2019 to 2022 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)