Trial · NCT01822535

Body Temperature in Persons With Tetraplegia When Exposed to Cold

NCT01822535, Phase 4, Completed, James J. Peters Veterans Affairs Medical Center; results first posted 2016-03-04

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Body Temperature in Persons With Tetraplegia When Exposed to Cold. Trials, record NCT01822535. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01822535

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Body Temperature in Persons With Tetraplegia When Exposed to Cold
NCT number: NCT01822535
Status: Completed
Phases: Phase 4
Enrollment: 30 participants, actual
Lead sponsor: James J. Peters Veterans Affairs Medical Center
Conditions: Tetraplegia, Hypothermia, Mild Cognitive Impairment
Interventions: Midodrine hydrochloride
First posted: 2013-04-02
Last updated: 2016-03-04
Results first posted: 2016-03-04
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Visit 1: Percent Change in Core Body Temperature	Baseline, Up to 2 hours	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.
Primary	Visit 2: Percent Change in Core Body Temperature With Midodrine	Baseline, Baseline Post-midodrine, Up to 2 hours	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.
Secondary	Visit 1: Percent Changes in Cognitive Performance - Stroop Interference	Baseline, Up to 2 hours	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.
Secondary	Visit 1: Percent Changes in Cognitive Performance - Delayed Recall	Baseline, Up to 2 hours	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Visit 1: Percent Change in Core Body Temperature	Baseline, Up to 2 hours	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.	Percent Change	MEAN
SECONDARY	Visit 1: Percent Changes in Cognitive Performance - Stroop Interference	Baseline, Up to 2 hours	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.	Percent Change	MEAN
SECONDARY	Visit 1: Percent Changes in Cognitive Performance - Delayed Recall	Baseline, Up to 2 hours	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.	Percent Change	MEAN
PRIMARY	Visit 2: Percent Change in Core Body Temperature With Midodrine	Baseline, Baseline Post-midodrine, Up to 2 hours	Subjects analyzed were individuals who completed visit 1 of testing.	Percent Change	MEAN

Source ClinicalTrials.gov

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Visit 1: Percent Change in Core Body Temperature	Tetraplegia	-1.2	Standard Deviation 0.33	Percent Change
Visit 1: Percent Change in Core Body Temperature	Able-bodied	0.05	Standard Deviation 0.21	Percent Change
Visit 1: Percent Changes in Cognitive Performance - Stroop Interference	Tetraplegia	-3.9	Standard Deviation 3.8	Percent Change
Visit 1: Percent Changes in Cognitive Performance - Stroop Interference	Able-bodied	5.4	Standard Deviation 9.2	Percent Change
Visit 1: Percent Changes in Cognitive Performance - Delayed Recall	Tetraplegia	-55.2	Standard Deviation 47.4	Percent Change
Visit 1: Percent Changes in Cognitive Performance - Delayed Recall	Able-bodied (AB)	6.4	Standard Deviation 49.7	Percent Change
Visit 2: Percent Change in Core Body Temperature With Midodrine	Tetraplegia	-2.2	Standard Deviation 0.9	Percent Change

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Visit 1 - Tetraplegia and Able-Bodied	STARTED	Tetraplegia	17
Visit 1 - Tetraplegia and Able-Bodied	STARTED	Able-bodied (AB)	13
Visit 1 - Tetraplegia and Able-Bodied	COMPLETED	Tetraplegia	11
Visit 1 - Tetraplegia and Able-Bodied	COMPLETED	Able-bodied (AB)	11
Visit 1 - Tetraplegia and Able-Bodied	NOT COMPLETED	Tetraplegia	6
Visit 1 - Tetraplegia and Able-Bodied	NOT COMPLETED	Able-bodied (AB)	2
Visit 2 - Tetraplegia Only - Drug	STARTED	Tetraplegia	11
Visit 2 - Tetraplegia Only - Drug	STARTED	Able-bodied (AB)	0
Visit 2 - Tetraplegia Only - Drug	COMPLETED	Tetraplegia	10
Visit 2 - Tetraplegia Only - Drug	COMPLETED	Able-bodied (AB)	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Neck pain	Musculoskeletal and connective tissue disorders	No Drug: Tetraplegia	1	17	1
other	Neck pain	Musculoskeletal and connective tissue disorders	No Drug: Able-bodied	0	13	0
other	Neck pain	Musculoskeletal and connective tissue disorders	Drug: Tetraplegia	0	11	0
serious	Autonomic Dysreflexia	Nervous system disorders	No Drug: Tetraplegia	1	17	1
serious	Autonomic Dysreflexia	Nervous system disorders	No Drug: Able-bodied	0	13	0
serious	Autonomic Dysreflexia	Nervous system disorders	Drug: Tetraplegia	1	11	1

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	No Drug: Tetraplegia
Total, all-cause mortality	No Drug: Able-bodied
Total, all-cause mortality	Drug: Tetraplegia
Total, other adverse events	No Drug: Tetraplegia	1	17
Total, other adverse events	No Drug: Able-bodied	0	13
Total, other adverse events	Drug: Tetraplegia	0	11
Total, serious adverse events	No Drug: Tetraplegia	1	17
Total, serious adverse events	No Drug: Able-bodied	0	13
Total, serious adverse events	Drug: Tetraplegia	1	11

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25531297	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Stroop Color-Word Test	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT01822535/registered

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