Trial Outcomes & Findings for Effect of Heat Exposure on Cognition in Persons With Tetraplegia (NCT NCT02488824)
NCT ID: NCT02488824
Last Updated: 2019-11-18
Results Overview
The investigators measured the effects of warm temperature (95 F) exposure, of up to 120 minutes, on the ability to maintain a constant body temperature (e.g., core temperature of 98.6 F) in both groups of subjects. Core temperature was measured at baseline (thermoneutral) and after 120 minutes of warm temperature exposure (Warm Challenge). The change in core temperature from baseline to 120 minutes of Warm Challenge was calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
From Baseline to 120 Minutes
Results posted on
2019-11-18
Participant Flow
Participant milestones
| Measure |
Experimental: Warm Temperature Exposure in Tetraplegia
Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 deg F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 deg F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
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Active Comparator: Warm Temperature Exposure in Able-Bodied
Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 deg F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 deg F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
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|---|---|---|
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Overall Study
STARTED
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21
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20
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Overall Study
COMPLETED
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20
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19
|
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Overall Study
NOT COMPLETED
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1
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1
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Reasons for withdrawal
| Measure |
Experimental: Warm Temperature Exposure in Tetraplegia
Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 deg F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 deg F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
|
Active Comparator: Warm Temperature Exposure in Able-Bodied
Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 deg F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 deg F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
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|---|---|---|
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Overall Study
Adverse Event
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1
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1
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Baseline Characteristics
Effect of Heat Exposure on Cognition in Persons With Tetraplegia
Baseline characteristics by cohort
| Measure |
Experimental: Warm Temperature Exposure in Tetraplegia
n=20 Participants
Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
|
Active Comparator: Warm Temperature Exposure in Able-Bodied
n=19 Participants
Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
|
Total
n=39 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
42.4 years
STANDARD_DEVIATION 11.4 • n=99 Participants
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44.3 years
STANDARD_DEVIATION 13.8 • n=107 Participants
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43.3 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 120 MinutesThe investigators measured the effects of warm temperature (95 F) exposure, of up to 120 minutes, on the ability to maintain a constant body temperature (e.g., core temperature of 98.6 F) in both groups of subjects. Core temperature was measured at baseline (thermoneutral) and after 120 minutes of warm temperature exposure (Warm Challenge). The change in core temperature from baseline to 120 minutes of Warm Challenge was calculated.
Outcome measures
| Measure |
Experimental: Warm Temperature Exposure in Tetraplegia
n=20 Participants
Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
|
Active Comparator: Warm Temperature Exposure in Able-Bodied
n=19 Participants
Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
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|---|---|---|
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Change in Core Body Temperature From Baseline to 120 Minutes Post Warm Challenge
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0.59 degrees Centigrade
Standard Deviation 0.33
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-0.05 degrees Centigrade
Standard Deviation 0.23
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PRIMARY outcome
Timeframe: From Baseline to 120 MinutesCognitive performance was assessed using a neuropsychological battery. Cognitive performance was assessed at 2 time points, at the end of baseline and after heat exposure (warm challenge) in both groups of subjects. The Stroop Word test measures processing speed. A T-Score of 50 means "0" difference of actual - predicted score (based on subject's age \& education level). T-Scores \<40 are considered "low"; T-Scores \>40 are considered "normal". Changes of 10 or greater are considered clinically significant. The lowest possible T-Score is 21; the highest possible T-Score is 80. The WAIS-IV Digit Span Sequencing measures auditory processing and working memory. Each test score is converted to a scaled score (M=10, SD=3) with higher scores considered better performance. The lowest possible scaled score is 1; the highest possible scaled score is 19.
Outcome measures
| Measure |
Experimental: Warm Temperature Exposure in Tetraplegia
n=20 Participants
Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
|
Active Comparator: Warm Temperature Exposure in Able-Bodied
n=19 Participants
Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
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|---|---|---|
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Change in Cognitive Performance From Baseline to 120 Minutes Post Warm Challenge
Stroop Word
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6.2 Scores on a scale
Standard Deviation 5.5
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2.1 Scores on a scale
Standard Deviation 5.4
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Change in Cognitive Performance From Baseline to 120 Minutes Post Warm Challenge
WAIS-IV Digit Span Sequencing
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1.6 Scores on a scale
Standard Deviation 2.1
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0.3 Scores on a scale
Standard Deviation 2.1
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SECONDARY outcome
Timeframe: From Baseline to 120 MinutesThe investigators measured the effects of warm temperature (95 F) exposure, of up to 120 minutes, on the change in distal skin temperatures in the seated position.
Outcome measures
| Measure |
Experimental: Warm Temperature Exposure in Tetraplegia
n=20 Participants
Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
|
Active Comparator: Warm Temperature Exposure in Able-Bodied
n=19 Participants
Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
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|---|---|---|
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Change in Distal Skin Temperatures From Baseline to 120 Minutes Post Warm Challenge
|
3.9 degrees Centigrade
Standard Deviation 1.7
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3.9 degrees Centigrade
Standard Deviation 2.1
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SECONDARY outcome
Timeframe: From Baseline to 120 MinutesThe investigators measured the effects of warm temperature (95 F) exposure, of up to 120 minutes, on the change in sweat rate in the seated position.
Outcome measures
| Measure |
Experimental: Warm Temperature Exposure in Tetraplegia
n=20 Participants
Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
|
Active Comparator: Warm Temperature Exposure in Able-Bodied
n=19 Participants
Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
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|---|---|---|
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Change in Sweat Rate From Baseline to 120 Minutes Post Warm Challenge
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24.9 nL/min
Standard Deviation 31.8
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77.0 nL/min
Standard Deviation 52.5
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SECONDARY outcome
Timeframe: From Baseline to 120 MinutesThe investigators measured the effects of warm temperature (95 F) exposure, of up to 120 minutes, on the change in thermal sensitivity in the seated position on the 9-Point Thermal sensation scale (+4=very hot, +3=hot, +2=warm, +1=slightly warm, 0=neutral, -1=slightly cool, -2=cool, -3=cold, -4=very cold). A higher score means the subject feels hotter, which, for the identical heat challenge, means less effective thermoregulation.
Outcome measures
| Measure |
Experimental: Warm Temperature Exposure in Tetraplegia
n=20 Participants
Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
|
Active Comparator: Warm Temperature Exposure in Able-Bodied
n=19 Participants
Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
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|---|---|---|
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Change in Thermal Sensitivity From Baseline to 120 Minutes Post Warm Challenge
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3.3 score on a scale
Standard Deviation 1.2
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2.6 score on a scale
Standard Deviation 1.5
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Adverse Events
Experimental: Warm Temperature Exposure in Tetraplegia
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Active Comparator: Warm Temperature Exposure in Able-Bodied
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: Warm Temperature Exposure in Tetraplegia
n=20 participants at risk
Subjects are persons with higher-level spinal cord injury, levels C3 to T4, and ASIA Impairment Scale (AIS) level A and B, ages 18-68 years. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
|
Active Comparator: Warm Temperature Exposure in Able-Bodied
n=19 participants at risk
Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 F) for up to 2 hours in a temperature-controlled room in order to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance
Warm Temperature: Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
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|---|---|---|
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Vascular disorders
Autonomic dysreflexia
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5.0%
1/20 • Number of events 1 • 3 hours
1 person with in the group with SCI (Experimental) developed autonomic dysreflexia. 1 person in the able-bodied group (Active comparator) complained of dizziness most likely due to dehydration. The study was stopped for both persons and both persons returned to their baseline status before leaving the lab.
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0.00%
0/19 • 3 hours
1 person with in the group with SCI (Experimental) developed autonomic dysreflexia. 1 person in the able-bodied group (Active comparator) complained of dizziness most likely due to dehydration. The study was stopped for both persons and both persons returned to their baseline status before leaving the lab.
|
|
Vascular disorders
Dehydration
|
0.00%
0/20 • 3 hours
1 person with in the group with SCI (Experimental) developed autonomic dysreflexia. 1 person in the able-bodied group (Active comparator) complained of dizziness most likely due to dehydration. The study was stopped for both persons and both persons returned to their baseline status before leaving the lab.
|
5.3%
1/19 • Number of events 1 • 3 hours
1 person with in the group with SCI (Experimental) developed autonomic dysreflexia. 1 person in the able-bodied group (Active comparator) complained of dizziness most likely due to dehydration. The study was stopped for both persons and both persons returned to their baseline status before leaving the lab.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place