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The deleterious effects of hyperthermia are well appreciated in able-bodied persons. However, the consequences of impaired regulation of normal body temperature on cognitive performance of persons with tetraplegia is not known. This study will provide the preliminary findings necessary for future work to design and explore physical and medical interventions to improve temperature regulation in those with tetraplegia with the goal of improved clinical care, health, and quality of life.
The proposed study consists of 1 visit during which 20 subjects (10 with tetraplegia, 10 controls) will be exposed to 81°F for 40 minutes and then 95° F for up to 2 hours. Physiological as well as psychological processes will be monitored in all subjects during the study for safety and to determine differences in responses to exposure to hot ambient temperatures
After a cervical spinal cord injury (SCI) the motor, sensory and autonomic deficits cause, among other detriments, a blunted ability to maintain a constant core temperature. Impaired thermoregulation leaves persons with tetraplegia more susceptible to hyperthermia than able-bodied persons (AB). There has been a paucity of work addressing the thermoregulatory responses of persons with SCI to hot ambient temperatures, and even less study addressing the effect of these temperatures on cognitive performance. The goals of this pilot study are: to improve our understanding of the thermoregulatory mechanisms of individuals with tetraplegia when exposed to heat and to determine the effect of impaired thermoregulatory mechanisms on cognitive performance during exposure to 35°C for up to 2 hours. In order to address our goals we have designed a study methodology which consists of comparing the physiological and psychological responses of the two study groups (tetraplegia versus AB controls) from thermoneutral (27°C) to hot (35°C) environments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetraplegia | Persons with spinal cord injury, level of injury C4-T1, American Spinal Injury Association (ASIA) impairment levels A-B and duration of injury greater than 1 year. Ages 18-65 years old. |
| |
| Control | Age and gender-matched able-bodied controls. Ages 18-65 years old. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat Exposure | Other | Heat exposure of 95 degrees F for up to 2 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Core Body Temperature | To determine the change in core body temperature in the seated position from 79 degrees F for 30 minutes to 95 degrees F for up to 2 hours. Hypotheses: Persons with tetraplegia will have a greater increase in core body temperature than able-bodied (AB) control subjects. Core body temperature in AB persons will be maintained. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Performance - Stroop Interference T-Scores | To determine the change in cognitive performance as measured by the Stroop Color and Word Interference T-Scores, measured after 30 min at 79 degrees F and after up to 2 hours at 95 degrees F. Interference T-Scores are derived from the difference between the raw Color-Word score and the projected Color-Word score (which is, in turn, based on the raw scores obtained in the Word and Color portions of the Test). Lower scores indicate poorer performance, and a positive percent change in T-scores indicates improved performance. Hypothesis: Persons with tetraplegia compared with AB will have a greater change in cognitive performance from baseline (79 degrees) to warm exposure (95 degrees). |
| Measure | Description | Time Frame |
|---|---|---|
| Sweat Rate | To determine the change in sweat rate using QSweat methodology (WR TestWorks) from 30 minutes at 79 degrees F compared to after up to 2 hours at 95 degrees F. Sweat collection capsules will be placed on the left lateral anterior shoulder, volar aspect of the distal forearm, proximal anterior thigh, and mid-lateral calf (dermatomes C5, T1, L3, L5) for measurement of sweat rate. Hypothesis: Persons with tetraplegia compared with AB will have less of a percent change in average sweat rate after heat exposure. |
Inclusion Criteria:
Exclusion Criteria:
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10 subjects with tetraplegia (SCI, C4-T1), ages 18-65 years old and 10 age- and gender-matched, able-bodied controls will be accepted for participation.
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| Name | Affiliation | Role |
|---|---|---|
| John P Handrakis, PT, DPT, EdD | Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC | The Bronx | New York | 10468 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33882698 | Derived | Kumar NS, Bart J, Barton C, Graham ML, Leung PP, Tittley TD, Lee I, Bang C, Bauman WA, Handrakis JP. Core Temperature Lability Predicts Sympathetic Interruption and Cognitive Performance during Heat Exposure in Persons with Spinal Cord Injuries. J Neurotrauma. 2021 Aug 1;38(15):2141-2150. doi: 10.1089/neu.2020.7598. Epub 2021 May 26. | |
| 28462685 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tetraplegia | Persons with spinal cord injury, level of injury C4-T1, American Spinal Injury Association (ASIA) impairment levels A-B and duration of injury greater than 1 year. Ages 18-65 years old. Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours. |
| FG001 | Control | Age and gender-matched able-bodied controls. Ages 18-65 years old. Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tetraplegia | Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old. Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Core Body Temperature | To determine the change in core body temperature in the seated position from 79 degrees F for 30 minutes to 95 degrees F for up to 2 hours. Hypotheses: Persons with tetraplegia will have a greater increase in core body temperature than able-bodied (AB) control subjects. Core body temperature in AB persons will be maintained. | Posted | Mean | Standard Deviation | Percent Change | 2 hours |
|
Adverse events were reported within five business days to the VA's Institutional Review Board (IRB) via an Adverse Event form and were also included on the Adverse Events log on the annual continuing review application in accordance with VA IRB policy.
Adverse event data were collected throughout the entire course of the study, i.e. from 2012 to 2015.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tetraplegia | Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old. Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autonomic dysreflexia | Nervous system disorders | Systematic Assessment | Subject experienced autonomic dysreflexia (AD), presenting with high blood pressure, flushing, and diaphoresis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John P. Handrakis | James J. Peters VA Medical Center | 718-584-9000 | 5439 | john.handrakis@va.gov |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Venous blood samples
| 2 hours |
| 2 hours |
| Handrakis JP, Ni Guan Z, Nulty JW, Tascione O, Rosado-Rivera D, White D, Bang C, Spungen AM, Bauman WA. Effect of Heat Exposure on Cognition in Persons with Tetraplegia. J Neurotrauma. 2017 Dec 15;34(24):3372-3380. doi: 10.1089/neu.2016.4850. Epub 2017 Aug 16. |
| Equipment Malfunction |
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Age and gender-matched able-bodied controls. Ages 18-65 years old.
Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Cognitive Performance - Stroop Interference T-Scores | To determine the change in cognitive performance as measured by the Stroop Color and Word Interference T-Scores, measured after 30 min at 79 degrees F and after up to 2 hours at 95 degrees F. Interference T-Scores are derived from the difference between the raw Color-Word score and the projected Color-Word score (which is, in turn, based on the raw scores obtained in the Word and Color portions of the Test). Lower scores indicate poorer performance, and a positive percent change in T-scores indicates improved performance. Hypothesis: Persons with tetraplegia compared with AB will have a greater change in cognitive performance from baseline (79 degrees) to warm exposure (95 degrees). | Posted | Mean | Standard Deviation | Percent change | 2 hours |
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| Other Pre-specified | Sweat Rate | To determine the change in sweat rate using QSweat methodology (WR TestWorks) from 30 minutes at 79 degrees F compared to after up to 2 hours at 95 degrees F. Sweat collection capsules will be placed on the left lateral anterior shoulder, volar aspect of the distal forearm, proximal anterior thigh, and mid-lateral calf (dermatomes C5, T1, L3, L5) for measurement of sweat rate. Hypothesis: Persons with tetraplegia compared with AB will have less of a percent change in average sweat rate after heat exposure. | Posted | Mean | Standard Deviation | Percent change | 2 hours |
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| 1 |
| 11 |
| 0 |
| 11 |
| EG001 | Control | Age and gender-matched able-bodied controls. Ages 18-65 years old. Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours. | 0 | 10 | 0 | 10 |
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| D014947 | Wounds and Injuries |