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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. According to ClinicalTrials.gov, the official US trial registry.
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
Interventions
- PROCEDURE Warm Temperature
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2015-04-01 |
| Est. Completion | 2018-09-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02488824
The ClinicalTrials.gov registry entry for NCT02488824 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Warm Temperature is the first listed.
NCT02488824 reports 0 study locations.
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.
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