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NCT03185507 · ClinicalTrials.gov registry record · Phase 1

The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects

A Phase 1 study, sponsored by University of Virginia.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target

NCT03185507 is a Phase 1 study that has completed, run by University of Virginia. The registered enrollment target is 34 participants.

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The verdict

NCT03185507, a Phase 1 study, has completed, sponsored by University of Virginia.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

Upon suffering a concussion, a neurometabolic cascade including an increase in glucose and oxygen demand occurs for up to 48 hours post-insult.5 This period of increased glucose and oxygen demand is coupled with a period of hyperperfusion and decreased cerebral blood flow. 6-9 Cryotherapy in the musculoskeletal system has been shown to decrease tissue temperature, blood flow, oxygen and metabolic demands.10-17 Cryotherapy following moderate or severe traumatic brain injury has been demonstrated to decrease intracranial metabolic processes and oxygenation consumption.18-23 Although the benefits of cryotherapy have been established in moderate-severe TBI, the effects of superficial cranial cooling in individuals with and without concussion are unknown. The purpose of this randomized control trial is to evaluate the effects of superficial cryotherapy on cerebral blood flow and cognitive function in healthy, recreationally active young adults.

Interventions

  • DEVICE CryoHelmet

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2017-03-22
Est. Completion 2018-03-13
Phase Phase 1

Sponsor

University of Virginia

449 total trials

What the Registry Record Tells You About NCT03185507

The ClinicalTrials.gov registry entry for NCT03185507 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

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

NCT03185507 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03185507 about?

NCT03185507 is a clinical study titled "The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects". Upon suffering a concussion, a neurometabolic cascade including an increase in glucose and oxygen demand occurs for up to 48 hours post-insult.5 This period of increased glucose and oxygen demand is coupled with a period of hyperperfusion and decreased cerebral blood flow. 6-9 Cryotherapy in the mus...

What is the current status of trial NCT03185507?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2017-03-22. Estimated completion is 2018-03-13.

What interventions are being tested in trial NCT03185507?

The interventions under investigation include: CryoHelmet (DEVICE).

Who is sponsoring clinical trial NCT03185507?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.