Trial Outcomes & Findings for Body Temperature in Persons With Tetraplegia When Exposed to Heat (NCT NCT01890915)

NCT ID: NCT01890915

Last Updated: 2016-03-03

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 21 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2016-03-03

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	11	10
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	1	0
Overall Study Protocol Violation	2	0
Overall Study Equipment Malfunction	0	1

Baseline Characteristics

Body Temperature in Persons With Tetraplegia When Exposed to Heat

Baseline characteristics by cohort

Measure	Tetraplegia n=8 Participants 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.	Control n=9 Participants 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.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

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.

Outcome measures

Measure	Tetraplegia n=8 Participants 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.	Control n=9 Participants 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.
Core Body Temperature	2.04 Percent Change Standard Deviation 0.49	-0.05 Percent Change Standard Deviation 0.61

SECONDARY outcome

Timeframe: 2 hours

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).

Outcome measures

Measure	Tetraplegia n=8 Participants 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.	Control n=9 Participants 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.
Cognitive Performance - Stroop Interference T-Scores	8.3 Percent change Standard Deviation 5.9	0.3 Percent change Standard Deviation 6.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 hours

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.

Outcome measures

Measure	Tetraplegia n=8 Participants 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.	Control n=9 Participants 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.
Sweat Rate	51.4 Percent change Standard Deviation 12.6	1030.2 Percent change Standard Deviation 654.9

Adverse Events

Tetraplegia

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tetraplegia n=11 participants at risk 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.	Control n=10 participants at risk 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.
Nervous system disorders Autonomic dysreflexia	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/10 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Dr. John P. Handrakis

James J. Peters VA Medical Center

Phone: 718-584-9000

Email: john.handrakis@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place