Trial Outcomes & Findings for Body Temperature in Persons With Tetraplegia When Exposed to Cold (NCT NCT01822535)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Baseline, Up to 2 hours

Results posted on

2016-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Tetraplegia Lesion level C3-T1, American Spinal Injury Association (ASIA) impairment levels A and B, ages 18-68 years	Able-bodied (AB) Age- and gender-matched to individuals with tetraplegia.
Visit 1 - Tetraplegia and Able-Bodied STARTED	17	13
Visit 1 - Tetraplegia and Able-Bodied COMPLETED	11	11
Visit 1 - Tetraplegia and Able-Bodied NOT COMPLETED	6	2
Visit 2 - Tetraplegia Only - Drug STARTED	11	0
Visit 2 - Tetraplegia Only - Drug COMPLETED	10	0
Visit 2 - Tetraplegia Only - Drug NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Tetraplegia Lesion level C3-T1, American Spinal Injury Association (ASIA) impairment levels A and B, ages 18-68 years	Able-bodied (AB) Age- and gender-matched to individuals with tetraplegia.
Visit 1 - Tetraplegia and Able-Bodied Adverse Event	2	0
Visit 1 - Tetraplegia and Able-Bodied Withdrawal by Subject	4	2
Visit 2 - Tetraplegia Only - Drug Adverse Event	1	0

Baseline Characteristics

Body Temperature in Persons With Tetraplegia When Exposed to Cold

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tetraplegia n=11 Participants Lesion level T1 and above, ASIA levels A and B, ages 18-68 years	Able-bodied n=11 Participants Age- and gender-matched to individuals with tetraplegia.	Total n=22 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	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Up to 2 hours

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tetraplegia n=7 Participants Lesion level T1 and above, ASIA levels A and B, ages 18-68 years	Able-bodied n=7 Participants Age- and gender-matched to individuals with tetraplegia.
Visit 1: Percent Change in Core Body Temperature	-1.2 Percent Change Standard Deviation 0.33	0.05 Percent Change Standard Deviation 0.21

PRIMARY outcome

Timeframe: Baseline, Baseline Post-midodrine, Up to 2 hours

Population: Subjects analyzed were individuals who completed visit 1 of testing.

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.

Outcome measures

Outcome measures
Measure	Tetraplegia n=7 Participants Lesion level T1 and above, ASIA levels A and B, ages 18-68 years	Able-bodied Age- and gender-matched to individuals with tetraplegia.
Visit 2: Percent Change in Core Body Temperature With Midodrine	-2.2 Percent Change Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: Baseline, Up to 2 hours

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tetraplegia n=7 Participants Lesion level T1 and above, ASIA levels A and B, ages 18-68 years	Able-bodied n=7 Participants Age- and gender-matched to individuals with tetraplegia.
Visit 1: Percent Changes in Cognitive Performance - Stroop Interference	-3.9 Percent Change Standard Deviation 3.8	5.4 Percent Change Standard Deviation 9.2

SECONDARY outcome

Timeframe: Baseline, Up to 2 hours

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tetraplegia n=7 Participants Lesion level T1 and above, ASIA levels A and B, ages 18-68 years	Able-bodied n=7 Participants Age- and gender-matched to individuals with tetraplegia.
Visit 1: Percent Changes in Cognitive Performance - Delayed Recall	-55.2 Percent Change Standard Deviation 47.4	6.4 Percent Change Standard Deviation 49.7

Adverse Events

No Drug: Tetraplegia

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

No Drug: Able-bodied

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Drug: Tetraplegia

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	No Drug: Tetraplegia n=17 participants at risk Lesion level C3-T1, ASIA levels A and B, ages 18-68 years	No Drug: Able-bodied n=13 participants at risk Age- and gender-matched to individuals with tetraplegia.	Drug: Tetraplegia n=11 participants at risk Those individuals with tetraplegia who completed visit 1 of testing (i.e. no drug)
Nervous system disorders Autonomic Dysreflexia	5.9% 1/17 • Number of events 1 • 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.	0.00% 0/13 • 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.	9.1% 1/11 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	No Drug: Tetraplegia n=17 participants at risk Lesion level C3-T1, ASIA levels A and B, ages 18-68 years	No Drug: Able-bodied n=13 participants at risk Age- and gender-matched to individuals with tetraplegia.	Drug: Tetraplegia n=11 participants at risk Those individuals with tetraplegia who completed visit 1 of testing (i.e. no drug)
Musculoskeletal and connective tissue disorders Neck pain	5.9% 1/17 • Number of events 1 • 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.	0.00% 0/13 • 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.	0.00% 0/11 • 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.

Additional Information

Dr. John P. Handrakis

James J. Peters VA Medical Center

Phone: 718-584-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place