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Sponsor study identifier
Secondary identifiers
OTHER · James J. Peters Veterans Affairs Medical Center
OTHER · James J Peters VAMC IRB
interventional
41
1 country
1
Study Start
April 1, 2015
Actual (reported)Primary Completion
September 4, 2018
Actual (reported)Study Completion
September 4, 2018
Actual (reported)The ability to maintain normal body temperature (Tcore) is impaired in persons with tetraplegia: subnormal Tcore and vulnerability to hypothermia (\<95 F) have been documented in this population after exposure to even mild environmental temperatures. However, no work to date has addressed the effect of subnormal Tcore on cognitive performance in persons with tetraplegia despite studies with able-bodied (AB) individuals that have documented progressive decline in various aspects of cognitive performance associated with the magnitude of the depression in Tcore. The investigators' study will confirm and extend their initial observations in persons with higher cord lesions who have subnormal Tcore to show that cognitive performance will be improved by raising Tcore to euthermic levels. This improvement should be associated with greater function and independence, reintegration into society, and an improved quality of life. Specific Aims: During exposure to 95 F for up to 120 minutes in the seated position, the investigators' aims are: Primary Specific Aim: To determine if a modest rise in Tcore to euthermic levels has a positive effect on cognitive performance (attention, working memory, processing speed, and executive function) in persons with higher-level spinal cord injury (SCI). Primary Hypothesis: Based on the investigators' pilot data: (1) 80% of persons with SCI will demonstrate an increase of 1 F in Tcore, while none of the AB controls will demonstrate such an increase; (2) 80% of persons with SCI will have an improvement of at least one T-score in Stroop Interference scores (a validated measure of executive function), while none of the AB controls will demonstrate a change in cognitive performance. Secondary Specific Aim: To determine changes in: (1) The average of distal skin temperatures; (2) Sweat rate; and (3) Subjective rating of thermal sensitivity. Secondary Hypothesis: Persons with SCI will have less of a percent change in average distal skin temperatures and sweat rate, and will report blunted ratings of thermal sensitivity compared to that of AB controls.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 4, 2018
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2015
Actual (reported)April 20, 2015
Actual (reported)July 2, 2015
Actual (reported)September 4, 2018
Actual (reported)September 4, 2018
Actual (reported)November 1, 2019
Actual (reported)Change in Core Body Temperature From Baseline to 120 Minutes Post Warm Challenge
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.
From Baseline to 120 Minutes
Change in Cognitive Performance From Baseline to 120 Minutes Post Warm Challenge
Cognitive 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.
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 degrees Fahrenheit) 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
Subjects are able-bodied controls matched with participants with tetraplegia for age and gender. Procedure is exposure to warm temperature (95 degrees Fahrenheit) 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
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468, United States
John Philip Handrakis, PT DPT EdD
James J. Peters Veterans Affairs Medical Center
41 participants (actual enrollment reported by the registry).
First Submitted
April 20, 2015
First Posted
July 2, 2015
Study Start
April 1, 2015
Actual (reported)From Baseline to 120 Minutes
Change in Distal Skin Temperatures From Baseline to 120 Minutes Post Warm Challenge
From Baseline to 120 Minutes
Change in Sweat Rate From Baseline to 120 Minutes Post Warm Challenge
From Baseline to 120 Minutes
Change in Thermal Sensitivity From Baseline to 120 Minutes Post Warm Challenge
From Baseline to 120 Minutes
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Primary Completion
September 4, 2018
Actual (reported)Study Completion
September 4, 2018
Actual (reported)Last Updated
November 18, 2019
Results First Posted
November 1, 2019
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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