Catalyst Cryohelmet for Traumatic Brain Injury (TBI)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spectrum Health Lakeland, Saint Joseph, MI
Traumatic Brain Injury (TBI)+6 More
Catalyst Cryohelmet - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Traumatic Brain Injury (TBI)
  • Mild Concussion

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Traumatic Brain Injury (TBI)

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 72 hours

1 hour
Patient Returns to Baseline Function of 0 by 1 hour survey
48 hours
Patient Returns to Baseline Function of 0 by 48 hour survey
72 hours
Patient Returns to Baseline Function of 0 by 72 hour survey
Post-Concussion Symptom Severity Score Index case report form
Hour 6
Adverse Effects from medication
Any other medications given during the Emergency Department (ED) stay

Trial Safety

Safety Progress

1 of 3

Other trials for Traumatic Brain Injury (TBI)

Trial Design

2 Treatment Groups

Control: symptomatic care arm
1 of 2
Catalyst Cryohelmet intervention with symptomatic care
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Catalyst Cryohelmet · No Placebo Group · N/A

Catalyst Cryohelmet intervention with symptomatic care
Device
Experimental Group · 1 Intervention: Catalyst Cryohelmet · Intervention Types: Device
Control: symptomatic care armNoIntervention Group · 1 Intervention: Control: symptomatic care arm · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 72 hours
Closest Location: Spectrum Health Lakeland · Saint Joseph, MI
Photo of michigan 1Photo of michigan 2Photo of michigan 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Traumatic Brain Injury (TBI)
0 CompletedClinical Trials

Who is running the clinical trial?

Spectrum Health - LakelandLead Sponsor
11 Previous Clinical Trials
1,352 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Headache, head injury, or concussion presenting within the first 24 hours of injury.
You have a GCS > 13 on arrival.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References