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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: Completed Phase 1 study, sponsored by University of Virginia.
NCT03185507 is a Phase 1 study that has completed, run by University of Virginia. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Oxygenated blood based on functional near-infrared spectroscopy (fNIRS) data output
Interventions
- DEVICE CryoHelmet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2017-03-22 |
| Est. Completion | 2018-03-13 |
| Phase | Phase 1 |
What the finished NCT03185507 record still lists
NCT03185507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which CryoHelmet is the first listed.
NCT03185507 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03185507's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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