Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed Phase 4 study of Mild Cognitive Impairment and Tetraplegia, sponsored by James J. Peters Veterans Affairs Medical Center.

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Primary Outcome

We measured the effects of cool temperature (64°F) exposure, of up to 120 minutes, on the ability to maintain a constant Tcore (i.e., Tcore of 98.6°F) in all intervention arms.

Conditions Studied

Mild Cognitive Impairment Tetraplegia Hypothermia

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

FieldValue
Enrollment Target 30 participants
Start Date 2015-04
Est. Completion 2022-12
Phase Phase 4
James J. Peters Veterans Affairs Medical Center

39 total trials

What the finished NCT02379156 record still lists

NCT02379156 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (98% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Mild Cognitive Impairment

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02379156's enrollment target sits among peer trials

30 166th of 205 higher than 37 of 205 other Mild Cognitive Impairment trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Mild Cognitive Impairment 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00977977 · 30 participants · Phase 2

    Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy

  • NCT01459107 · 30 participants · Phase 2

    Human Upper Extremity Allotransplantation

  • NCT01666080 · 30 participants · NA

    Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

  • NCT01720836 · 30 participants · Phase 1

    Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Related registry views

Source: ClinicalTrials.gov NCT02379156, the US trial registry maintained by the National Library of Medicine. NCT02379156 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.