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Body Temperature in Persons With Tetraplegia When Exposed to Cold

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ClinicalTrials.gov Identifier: NCT01822535
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
John Handrakis, PT, DPT, EdD, James J. Peters Veterans Affairs Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label)
Conditions Tetraplegia
Hypothermia
Mild Cognitive Impairment
Intervention Drug: Midodrine hydrochloride
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tetraplegia Able-bodied (AB)
Hide Arm/Group Description Lesion level C3-T1, American Spinal Injury Association (ASIA) impairment levels A and B, ages 18-68 years Age- and gender-matched to individuals with tetraplegia.
Period Title: Visit 1 - Tetraplegia and Able-Bodied
Started 17 13
Completed 11 11
Not Completed 6 2
Reason Not Completed
Adverse Event             2             0
Withdrawal by Subject             4             2
Period Title: Visit 2 - Tetraplegia Only - Drug
Started 11 [1] 0 [2]
Completed 10 0
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
[1]
These subjects were individuals who completed Visit 1 of testing.
[2]
Able-bodied subjects were not enrolled for a second visit.
Arm/Group Title Tetraplegia Able-bodied Total
Hide Arm/Group Description Lesion level T1 and above, ASIA levels A and B, ages 18-68 years Age- and gender-matched to individuals with tetraplegia. Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  90.9%
11
 100.0%
21
  95.5%
>=65 years
1
   9.1%
0
   0.0%
1
   4.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
11
 100.0%
11
 100.0%
22
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 22 participants
11 11 22
1.Primary Outcome
Title Visit 1: Percent Change in Core Body Temperature
Hide Description We will test the effects of cool temperature (64°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 persons with tetraplegia through comparing the percent changes in core body temperatures between groups from baseline to after cool exposure.
Time Frame Baseline, Up to 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.
Arm/Group Title Tetraplegia Able-bodied
Hide Arm/Group Description:
Lesion level T1 and above, ASIA levels A and B, ages 18-68 years
Age- and gender-matched to individuals with tetraplegia.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: Percent Change
-1.2  (0.33) 0.05  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tetraplegia, Able-bodied
Comments Between-group differences in percent changes in core body temperature from baseline values to after cool exposure were analyzed. Because individuals with tetraplegia have impaired thermoregulatory mechanisms, we hypothesized that their percent change in core body temperature would be significantly larger than that of able-bodied controls.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Visit 2: Percent Change in Core Body Temperature With Midodrine
Hide Description We will test the effects of midodrine on the ability to maintain a constant body temperature (e.g., core temperature of 98.6°F) after exposure to cool temperatures (64°F) in persons with tetraplegia through comparing the percent changes in core body temperature during visit 1 to percent changes in core body temperature during visit 2.
Time Frame Baseline, Baseline Post-midodrine, Up to 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects analyzed were individuals who completed visit 1 of testing.
Arm/Group Title Tetraplegia
Hide Arm/Group Description:
Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Percent Change
-2.2  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tetraplegia
Comments

We hypothesized that administration of midodrine would attenuate the fall in core body temperature.

Within-group percent changes in core body temperature were analyzed to compare data from visit 1 (no drug) to visit 2 (drug).

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Visit 1: Percent Changes in Cognitive Performance - Stroop Interference
Hide Description Cognitive performance will be evaluated using the Interference T-Scores obtained using the Stroop Color and Word Test. We will measure the change in cognitive performance in persons with tetraplegia after exposure to a cool environment (64°F) of up to 120 min in the seated position. Note: 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.
Time Frame Baseline, Up to 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.
Arm/Group Title Tetraplegia Able-bodied
Hide Arm/Group Description:
Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
Age- and gender-matched to individuals with tetraplegia.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: Percent Change
-3.9  (3.8) 5.4  (9.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tetraplegia, Able-bodied
Comments

Between-group comparisons of percent changes in Stroop Interference T-scores from baseline values to after cool exposure were analyzed.

We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Visit 1: Percent Changes in Cognitive Performance - Delayed Recall
Hide Description Cognitive performance will be evaluated using the Delayed Recall obtained using the Memory section of the Montreal Cognitive Assessment (MoCA). We will measure the change in cognitive performance in persons with tetraplegia after exposure to a cool environment (64°F) of up to 120 min in the seated position. Note: Scores are based on individual performance. All subjects are asked to remember two lists of five words (one list during baseline, and one list during cool Challenge). Lower scores indicate poorer performance, and a positive percent change in indicates improved cognitive performance.
Time Frame Baseline, Up to 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.
Arm/Group Title Tetraplegia Able-bodied (AB)
Hide Arm/Group Description:
Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
Age- and gender-matched to individuals with tetraplegia.
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: Percent Change
-55.2  (47.4) 6.4  (49.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tetraplegia, Able-bodied (AB)
Comments

Between-group comparisons of percent changes in Delayed Recall from baseline values to after cool exposure were analyzed.

We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0431
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Throughout the entire study, i.e. 2011-2015, adverse events (AEs) were reported within 5 business days to the Institutional Review Board (IRB) via an AE form and included on the AE log on the annual continuing review application to comply with IRB policy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Drug: Tetraplegia No Drug: Able-bodied Drug: Tetraplegia
Hide Arm/Group Description Lesion level C3-T1, ASIA levels A and B, ages 18-68 years Age- and gender-matched to individuals with tetraplegia. Those individuals with tetraplegia who completed visit 1 of testing (i.e. no drug)
All-Cause Mortality
No Drug: Tetraplegia No Drug: Able-bodied Drug: Tetraplegia
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
No Drug: Tetraplegia No Drug: Able-bodied Drug: Tetraplegia
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      0/13 (0.00%)      1/11 (9.09%)    
Nervous system disorders       
Autonomic Dysreflexia  [1]  1/17 (5.88%)  1 0/13 (0.00%)  0 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
[1]
Subject experienced autonomic dysreflexia (i.e. increased blood pressure, decreased heart rate, diaphoresis) due to a need to be catheterized. Once catheterized, subject’s blood pressure and heart rate returned to normal.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Drug: Tetraplegia No Drug: Able-bodied Drug: Tetraplegia
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      0/13 (0.00%)      0/11 (0.00%)    
Musculoskeletal and connective tissue disorders       
Neck pain  [1]  1/17 (5.88%)  1 0/13 (0.00%)  0 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Subject experienced neck pain due to excessive muscle tightness, secondary to cold exposure.

Did not assess cognitive performance a third time, after Tcore in the group with tetraplegia had returned to baseline levels.

Study had a small sample size, and only included males.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. John P. Handrakis
Organization: James J. Peters VA Medical Center
Phone: 718-584-9000 ext 5439
Responsible Party: John Handrakis, PT, DPT, EdD, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01822535     History of Changes
Other Study ID Numbers: 01374
First Submitted: March 21, 2013
First Posted: April 2, 2013
Results First Submitted: November 23, 2015
Results First Posted: March 4, 2016
Last Update Posted: March 4, 2016