Trial Outcomes & Findings for Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia (NCT NCT02379156)
NCT ID: NCT02379156
Last Updated: 2025-03-21
Results Overview
We measured the effects of cool temperature (64°F) exposure, of up to 120 minutes, on the ability to maintain a constant Tcore (i.e., Tcore of 98.6°F) in all intervention arms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
120 minutes
Results posted on
2025-03-21
Participant Flow
Participant milestones
| Measure |
Able-bodied Cool Temperature Exposure / No Drug
Subjects are able-bodied persons, ages 18-65 years matched for age and gender to the SCI group. Procedure is exposure to cool temperature (64° 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 (Visit 1).
Cool Temperature: Subjects will be exposed to a routinely encountered cool temperature (64° F) for up to to 2 hours depending on the vital signs (Blood Pressure, Heart Rate, Tcore) and tolerance (comfort).
|
SCI Cool Temperature Exposure With no Drug First, Then SCI Cool Temperature Exposure With Midodrine
The study consists of two visits separated by a 14-day washout period.
The subjects are persons with tetraplegia: spinal cord lesion levels C3 to T1, American Spinal Injury Association Impairment Scale (AIS) levels A and B, ages 18-65. The Cool Temperature Exposure consists of a 64° F temperature-controlled room for up to 2 hours.
Visit 1 (120 minutes, SCI Cool Exposure without drug) consists of SCI Cool Temperature Exposure for up to 2 hours to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
A washout period of 14 days separates Visit 1 and Visit 2.
In Visit 2 (120 minutes, SCI Cool Exposure with drug), subjects who completed Visit 1 and did not rescind their study participation during the washout period are administered a 10 mg tablet of midodrine hydrochloride by a physician before being exposed to cool temperature (64° F) for up to 2 hours in a temperature-controlled room to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia
Baseline characteristics by cohort
| Measure |
Able-bodied Cool Temperature Exposure / No Drug
n=15 Participants
Subjects are able-bodied persons, ages 18-65 years matched for age and gender to the SCI group. Procedure is exposure to cool temperature (64° 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 (Visit 1).
Cool Temperature: Subjects will be exposed to a routinely encountered cool temperature (64° F) for up to to 2 hours depending on the vital signs (Blood Pressure, Heart Rate, Tcore) and tolerance (comfort).
|
SCI Cool Temperature Exposure With no Drug First, Then SCI Cool Temperature Exposure With Midodrine
n=12 Participants
The study consists of two visits separated by a 14-day washout period. The subjects are persons with tetraplegia: spinal cord lesion levels C3 to T1, AIS levels A and B, ages 18-65. The Cool Temperature Exposure consists of a 64° F temperature-controlled room for up to 2 hours.
Visit 1 (120 minutes, SCI Cool Exposure without drug) consists of SCI Cool Temperature Exposure for up to 2 hours to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
A washout period of 14 days separates Visit 1 and Visit 2. In Visit 2 (120 minutes, SCI Cool Exposure with drug), subjects who completed Visit 1 and did not rescind their study participation during the washout period are administered a 10 mg tablet of midodrine hydrochloride by a physician before being exposed to cool temperature (64° F) for up to 2 hours in a temperature-controlled room to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
|
Total
n=27 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
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 11.38 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
41.1 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White Non-Hispanic
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.42 Kg/m^2
STANDARD_DEVIATION 5.28 • n=5 Participants
|
25.19 Kg/m^2
STANDARD_DEVIATION 2.77 • n=7 Participants
|
25.93 Kg/m^2
STANDARD_DEVIATION 0.46 • n=5 Participants
|
PRIMARY outcome
Timeframe: 120 minutesWe measured the effects of cool temperature (64°F) exposure, of up to 120 minutes, on the ability to maintain a constant Tcore (i.e., Tcore of 98.6°F) in all intervention arms.
Outcome measures
| Measure |
Able-bodied Control Cool Temperature Exposure / No Drug
n=15 Participants
Subjects are able-bodied (AB) persons, ages 18-65. AB participants were matched to the SCI group by age and gender. Procedure is exposure to cool temperature (64° 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 (Visit 1).
Cool Temperature: Subjects will be exposed to a routinely encountered cool temperature (64° F) for up to to 2 hours depending on the vital signs (Blood Pressure (BP), Heart Rate (HR), Tcore) and tolerance (comfort).
|
SCI Cool Temperature Exposure With no Drug First, Then SCI Cool Temperature Exposure With Midodrine
n=12 Participants
The study consists of two visits separated by a 14-day washout period. The subjects are persons with tetraplegia: spinal cord lesion levels C3 to T1, AIS levels A and B, ages 18-65. The Cool Temperature Exposure consists of a 64° F temperature-controlled room for up to 2 hours.
Visit 1 (120 minutes, SCI Cool Exposure without drug) consists of SCI Cool Temperature Exposure for up to 2 hours to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
A washout period of 14 days separates Visit 1 and Visit 2. In Visit 2 (120 minutes, SCI Cool Exposure with drug), subjects who completed Visit 1 and did not rescind their study participation during the washout period are administered a 10 mg tablet of midodrine hydrochloride by a physician before being exposed to cool temperature (64° F) for up to 2 hours in a temperature-controlled room to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
|
|---|---|---|
|
Change in Core Body Temperature
Change in Core Temperature during Cool Temperature Exposure (64 °F, 120 minutes), no drug
|
-0.24 °C
Standard Deviation 0.33
|
-0.97 °C
Standard Deviation 0.33
|
|
Change in Core Body Temperature
Change in Core Temperature during Cool Temperature Exposure (64 °F, 120 minutes), drug
|
NA °C
Standard Deviation NA
Midodrine hydrochloride (HCl) was not given to Able-Bodied controls.
|
0.79 °C
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 120 minutesCognitive performance was assessed using the Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV) Digit Span test, which measures working memory and attention. The test consists of three subtests: Digit Span Forward, Digit Span Backward, and Digit Span Sequencing. Each subtest yields a scaled score ranging from 1 to 19 based on age-based normative data. The total scaled score is obtained by summing the three subtest scores, resulting in a possible total scaled score range of 3 to 57. For each subtest (Digit Span Forward, Digit Span Backward, and Digit Span Sequencing) and for the total scaled score, higher scores indicate better working memory performance (better outcome), while lower scores indicate poorer working memory performance (worse outcome). Assessments were conducted at baseline (BL) and after cold ambient exposure. The reported results represent the percent change in each participant's total scaled score from baseline to post-exposure (\[(Cold - BL) / BL\] × 100).
Outcome measures
| Measure |
Able-bodied Control Cool Temperature Exposure / No Drug
n=15 Participants
Subjects are able-bodied (AB) persons, ages 18-65. AB participants were matched to the SCI group by age and gender. Procedure is exposure to cool temperature (64° 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 (Visit 1).
Cool Temperature: Subjects will be exposed to a routinely encountered cool temperature (64° F) for up to to 2 hours depending on the vital signs (Blood Pressure (BP), Heart Rate (HR), Tcore) and tolerance (comfort).
|
SCI Cool Temperature Exposure With no Drug First, Then SCI Cool Temperature Exposure With Midodrine
n=12 Participants
The study consists of two visits separated by a 14-day washout period. The subjects are persons with tetraplegia: spinal cord lesion levels C3 to T1, AIS levels A and B, ages 18-65. The Cool Temperature Exposure consists of a 64° F temperature-controlled room for up to 2 hours.
Visit 1 (120 minutes, SCI Cool Exposure without drug) consists of SCI Cool Temperature Exposure for up to 2 hours to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
A washout period of 14 days separates Visit 1 and Visit 2. In Visit 2 (120 minutes, SCI Cool Exposure with drug), subjects who completed Visit 1 and did not rescind their study participation during the washout period are administered a 10 mg tablet of midodrine hydrochloride by a physician before being exposed to cool temperature (64° F) for up to 2 hours in a temperature-controlled room to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
|
|---|---|---|
|
Percent Change in Cognitive Performance - Wechsler Adult Intelligence Scale 4th Edition (WAIS IV)
Percent Change in Cognitive performance - (WAIS IV), no drug
|
3.81 Percent Change
Standard Deviation 15.90
|
-11.08 Percent Change
Standard Deviation 21.47
|
|
Percent Change in Cognitive Performance - Wechsler Adult Intelligence Scale 4th Edition (WAIS IV)
Percent Change in Cognitive performance - (WAIS IV), drug
|
NA Percent Change
Standard Deviation NA
Midodrine HCl was not given to Able-Bodied controls.
|
-1.73 Percent Change
Standard Deviation 16.98
|
SECONDARY outcome
Timeframe: 120 minutesWe measured the effects of cool ambient exposure (64°F) in each intervention arm by taping 4 thermocouples to the skin of distal areas of the extremities (i.e. the fingers and toes).
Outcome measures
| Measure |
Able-bodied Control Cool Temperature Exposure / No Drug
n=15 Participants
Subjects are able-bodied (AB) persons, ages 18-65. AB participants were matched to the SCI group by age and gender. Procedure is exposure to cool temperature (64° 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 (Visit 1).
Cool Temperature: Subjects will be exposed to a routinely encountered cool temperature (64° F) for up to to 2 hours depending on the vital signs (Blood Pressure (BP), Heart Rate (HR), Tcore) and tolerance (comfort).
|
SCI Cool Temperature Exposure With no Drug First, Then SCI Cool Temperature Exposure With Midodrine
n=12 Participants
The study consists of two visits separated by a 14-day washout period. The subjects are persons with tetraplegia: spinal cord lesion levels C3 to T1, AIS levels A and B, ages 18-65. The Cool Temperature Exposure consists of a 64° F temperature-controlled room for up to 2 hours.
Visit 1 (120 minutes, SCI Cool Exposure without drug) consists of SCI Cool Temperature Exposure for up to 2 hours to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
A washout period of 14 days separates Visit 1 and Visit 2. In Visit 2 (120 minutes, SCI Cool Exposure with drug), subjects who completed Visit 1 and did not rescind their study participation during the washout period are administered a 10 mg tablet of midodrine hydrochloride by a physician before being exposed to cool temperature (64° F) for up to 2 hours in a temperature-controlled room to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
|
|---|---|---|
|
Change in Distal Skin Temperature (Tsk)
Change in Distal Skin Temperature (Tsk), no drug
|
-10.82 °C
Standard Deviation 2.10
|
-4.35 °C
Standard Deviation 1.69
|
|
Change in Distal Skin Temperature (Tsk)
Change in Distal Skin Temperature (Tsk), drug
|
NA °C
Standard Deviation NA
Midodrine HCl was not given to Able-Bodied controls.
|
-1.45 °C
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Up to 120 minutesWe measured the effects of ambient cool exposure (64°F), for up to 120 minutes, on microvascular perfusion by taping laser doppler flowmetry (LDF) probes to the skin of the hands and feet. LDF was measured in all intervention arms and compared the percent changes in microvascular perfusion within and between groups.
Outcome measures
| Measure |
Able-bodied Control Cool Temperature Exposure / No Drug
n=15 Participants
Subjects are able-bodied (AB) persons, ages 18-65. AB participants were matched to the SCI group by age and gender. Procedure is exposure to cool temperature (64° 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 (Visit 1).
Cool Temperature: Subjects will be exposed to a routinely encountered cool temperature (64° F) for up to to 2 hours depending on the vital signs (Blood Pressure (BP), Heart Rate (HR), Tcore) and tolerance (comfort).
|
SCI Cool Temperature Exposure With no Drug First, Then SCI Cool Temperature Exposure With Midodrine
n=12 Participants
The study consists of two visits separated by a 14-day washout period. The subjects are persons with tetraplegia: spinal cord lesion levels C3 to T1, AIS levels A and B, ages 18-65. The Cool Temperature Exposure consists of a 64° F temperature-controlled room for up to 2 hours.
Visit 1 (120 minutes, SCI Cool Exposure without drug) consists of SCI Cool Temperature Exposure for up to 2 hours to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
A washout period of 14 days separates Visit 1 and Visit 2. In Visit 2 (120 minutes, SCI Cool Exposure with drug), subjects who completed Visit 1 and did not rescind their study participation during the washout period are administered a 10 mg tablet of midodrine hydrochloride by a physician before being exposed to cool temperature (64° F) for up to 2 hours in a temperature-controlled room to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
|
|---|---|---|
|
Percent Change in Microvascular Perfusion
Percent Change in Microvascular Perfusion, no drug
|
-56.13 Percent change in arbitrary units
Standard Deviation 12.40
|
-10.93 Percent change in arbitrary units
Standard Deviation 41.34
|
|
Percent Change in Microvascular Perfusion
Percent Change in Microvascular Perfusion, drug
|
NA Percent change in arbitrary units
Standard Deviation NA
Midodrine HCl was not given to Able-Bodied controls.
|
-29.42 Percent change in arbitrary units
Standard Deviation 10.90
|
SECONDARY outcome
Timeframe: Up to 120 minutes.We measured the effects of ambient cool exposure (64°F), for up to 120 minutes, on oxygen consumption (VO2) as a measure of resting metabolic rate. VO2 was measured in all intervention arms to compare the percent changes within and between groups.
Outcome measures
| Measure |
Able-bodied Control Cool Temperature Exposure / No Drug
n=14 Participants
Subjects are able-bodied (AB) persons, ages 18-65. AB participants were matched to the SCI group by age and gender. Procedure is exposure to cool temperature (64° 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 (Visit 1).
Cool Temperature: Subjects will be exposed to a routinely encountered cool temperature (64° F) for up to to 2 hours depending on the vital signs (Blood Pressure (BP), Heart Rate (HR), Tcore) and tolerance (comfort).
|
SCI Cool Temperature Exposure With no Drug First, Then SCI Cool Temperature Exposure With Midodrine
n=12 Participants
The study consists of two visits separated by a 14-day washout period. The subjects are persons with tetraplegia: spinal cord lesion levels C3 to T1, AIS levels A and B, ages 18-65. The Cool Temperature Exposure consists of a 64° F temperature-controlled room for up to 2 hours.
Visit 1 (120 minutes, SCI Cool Exposure without drug) consists of SCI Cool Temperature Exposure for up to 2 hours to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
A washout period of 14 days separates Visit 1 and Visit 2. In Visit 2 (120 minutes, SCI Cool Exposure with drug), subjects who completed Visit 1 and did not rescind their study participation during the washout period are administered a 10 mg tablet of midodrine hydrochloride by a physician before being exposed to cool temperature (64° F) for up to 2 hours in a temperature-controlled room to assess the body's temperature-regulating mechanisms and any associated change in cognitive performance.
|
|---|---|---|
|
Percent Change in Oxygen Consumption (VO2)
Percent Change in oxygen consumption (VO2), no drug
|
-6.25 percent change in VO2
Standard Deviation 11.36
|
1.88 percent change in VO2
Standard Deviation 14.80
|
|
Percent Change in Oxygen Consumption (VO2)
Percent Change in oxygen consumption (VO2), drug
|
NA percent change in VO2
Standard Deviation NA
Midodrine HCl was not given to Able-Bodied controls.
|
1.13 percent change in VO2
Standard Deviation 16.72
|
Adverse Events
SCI Cool Temperature Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SCI Cool Temperature Exposure With Midodrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Able-bodied Cool Temperature Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place