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NCT05473897 · ClinicalTrials.gov registry record · NA
Cooling Helmets to Decrease Concussion Symptoms
A NA study, sponsored by Corewell Health South.
- Terminated
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT05473897: Clinical Trial NA study, sponsored by Corewell Health South.
NCT05473897 is a NA study that was terminated before completion, run by Corewell Health South. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05473897, a NA study, was terminated before completion, sponsored by Corewell Health South.
- TERMINATED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
Current therapy of Mild traumatic brain injuries (TBI) revolves around symptomatic care, rest, and return to school/sport/work after symptoms have resolved. The standard intervention for sufferers of mild traumatic brain injury is brain rest, which aims to decrease symptom intensity and duration, prevent re-injury and second impact syndrome via cessation of physical and cognitive activity, and to gradually increase activity as tolerated. Increased brain temperature can be a secondary injury result in TBI. There are limited studies, primarily in the sports medicine literature, that show head-neck cooling can be a useful adjunct as a treatment for mild TBI. Our objective will be to evaluate concussive symptoms via the Post-Concussion Symptom Severity Score Index by conducting patient follow up interviews at different timepoints over 72 hours after an emergency department visit for the head injury where head and neck cooling was applied.
Primary Outcome
Initial Survey of symptoms within the first 24 hours of injury before intervention Survey Title: Case Report Form: Post-Concussion Symptom Severity Score Index Where ratings range from 0-6: 0 as no symptoms, 1-2 as mild, 2-3 moderate and 5-6 severe The following symptoms will be quantitated: headache, nausea, vomiting, balance problems, dizziness, visual problems, fatigue, sensitivity to light, sensitivity to noise, numbness or tingling, pain other than headache, feeling as if "in a fog," feelin
Interventions
- DEVICE Catalyst Cryohelmet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-06-23 |
| Est. Completion | 2024-04-01 |
| Phase | NA |
Why NCT05473897 stopped before completion
NCT05473897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Catalyst Cryohelmet is the first listed.
NCT05473897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05473897 about?
NCT05473897 is a clinical study titled "Cooling Helmets to Decrease Concussion Symptoms". Current therapy of Mild traumatic brain injuries (TBI) revolves around symptomatic care, rest, and return to school/sport/work after symptoms have resolved. The standard intervention for sufferers of mild traumatic brain injury is brain rest, which aims to decrease symptom intensity and duration, pr...
What is the current status of trial NCT05473897?
This trial is currently terminated. It is a NA study. The enrollment target is 18 participants. The study started on 2022-06-23. Estimated completion is 2024-04-01.
What interventions are being tested in trial NCT05473897?
The interventions under investigation include: Catalyst Cryohelmet (DEVICE).
Who is sponsoring clinical trial NCT05473897?
This trial is sponsored by Corewell Health South, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05473897's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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