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NCT02488824 · ClinicalTrials.gov registry record · NA

Effect of Heat Exposure on Cognition in Persons With Tetraplegia

A NA study, sponsored by VA Office of Research and Development.

Completed
Registry status
NA
Development phase
41
Enrollment target

NCT02488824: Completed NA study, sponsored by VA Office of Research and Development.

NCT02488824 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 41 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02488824, a NA study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
NA
Development phase
41 participants
Enrollment target

Study Summary

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 temper

Primary Outcome

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.

Interventions

  • PROCEDURE Warm Temperature

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2015-04-01
Est. Completion 2018-09-04
Phase NA
VA Office of Research and Development

1,668 total trials

What the finished NCT02488824 record still lists

NCT02488824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Warm Temperature is the first listed.

NCT02488824 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02488824 about?

NCT02488824 is a clinical study titled "Effect of Heat Exposure on Cognition in Persons With Tetraplegia". 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...

What is the current status of trial NCT02488824?

This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2015-04-01. Estimated completion is 2018-09-04.

What interventions are being tested in trial NCT02488824?

The interventions under investigation include: Warm Temperature (PROCEDURE).

Who is sponsoring clinical trial NCT02488824?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02488824's enrollment target sits among peer trials

41 1446th of 2000 higher than 554 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02488824, the US trial registry maintained by the National Library of Medicine. NCT02488824 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.