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NCT02379156 · ClinicalTrials.gov registry record · Phase 4
Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia
A Phase 4 study of Mild Cognitive Impairment and Tetraplegia, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT02379156 is a Phase 4 study of Mild Cognitive Impairment and Tetraplegia that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 30 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02379156, a Phase 4 study of Mild Cognitive Impairment and Tetraplegia, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The ability to maintain normal core body temperature (Tcore = 98.6°F) is impaired in persons with a cervical spinal cord injury (tetraplegia). Despite the known deficits in the ability of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in able-bodied (AB) persons, there has been no work to date addressing these issues in persons with tetraplegia. Primary Aim: To determine if exposure of up to 2 hours to cool temperatures (64°F) causes Tcore to decrease in persons with tetraplegia, and if that decrease is associated with a decrease in cognitive function. Primary Hypotheses: Based on our pilot data: (1) 66% of persons with tetraplegia and none of the matched controls will demonstrate a decline of 1.8°F in Tcore; (2) 80% of persons with tetraplegia and 30% of controls will have a decline of at least one T-score in Stroop Interference scores (a measure of executive function). Secondary Aim: To determine the change in: (1) distal skin temperature, (2) metabolic rate, and (3) thermal sensitivity. Secondary Hypothesis: Persons with tetraplegia will have less of a percent change in average distal skin temperatures and metabolic rate, and report lower thermal sensitivity ratings compared with AB controls. Tertiary Aim: To determine if a 10 mg dose of an approved blood pressure-raising medicine (midodrine hydrochloride) will (1) reduce the decrease in Tcore and (2) prevent or delay the decline in cognitive performance in the group with tetraplegia compared to the exact same procedures performed on the day with no medicine (Visit 1) in that same group. Tertiary Hypothesis: Through administering a one-time dose of midodrine, the medicine-induced decreased blood flow to the skin will lessen the decline in Tcore and prevent or delay the associated decline in cognitive performance compared to the changes in Tcore and cognitive performance during cool temperature exposure without midodrine in the same group wit
Conditions Studied
Interventions
- DRUG Midodrine Hydrochloride
- OTHER Cool Temperature
Study Locations (1)
New York
- Center of Excellence for the Medical Consequences of SCI, James J Peters VAMC - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-04 |
| Est. Completion | 2022-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02379156
The ClinicalTrials.gov registry entry for NCT02379156 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (98% lower). The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which Midodrine Hydrochloride is the first listed.
NCT02379156 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT02379156 about?
NCT02379156 is a clinical study titled "Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia". The ability to maintain normal core body temperature (Tcore = 98.6°F) is impaired in persons with a cervical spinal cord injury (tetraplegia). Despite the known deficits in the ability of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental functio...
What is the current status of trial NCT02379156?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2015-04. Estimated completion is 2022-12.
What conditions does trial NCT02379156 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Tetraplegia, Hypothermia.
What interventions are being tested in trial NCT02379156?
The interventions under investigation include: Midodrine Hydrochloride (DRUG), Cool Temperature (OTHER).
Who is sponsoring clinical trial NCT02379156?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02379156 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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