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Cooling Helmets for Concussion (ColdCon Trial)

N/A

Recruiting

Research Sponsored by Spectrum Health - Lakeland

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

ColdCon Trial Summary

This trial is evaluating the use of cooling the head and neck as a treatment for mild traumatic brain injury (TBI). The standard intervention for TBI 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. This trial will 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.

Who is the study for?

This trial is for individuals aged 19-65 who've had a mild traumatic brain injury with symptoms like headaches within the first day of injury. They must have a Glasgow Coma Scale score over 13 and be able to consent. It's not for pregnant women, those with certain medical conditions, or severe migraines.Check my eligibility

What is being tested?

The study tests if cooling helmets (Catalyst Cryohelmet) can help reduce concussion symptoms after a head injury. Participants will use the helmet and their symptoms will be tracked using interviews over three days to see if there's improvement.See study design

What are the potential side effects?

Potential side effects may include discomfort from cold temperatures, skin irritation where the helmet contacts the head, and possible worsening of pre-existing conditions sensitive to cold exposure.

ColdCon Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post-Concussion Symptom Severity Score Index case report form

Secondary outcome measures

Pharmaceutical Preparations

Patient Returns to Baseline Function of 0 by 1 hour survey

+2 more

ColdCon Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Catalyst Cryohelmet intervention with symptomatic careExperimental Treatment1 Intervention

The treatment arm will receive symptomatic care (acetaminophen 1000mg and ondansetron 4mg) along with 30 minutes of head-neck cooling in the emergency department while being monitored for side effects.

Group II: Control: symptomatic care armActive Control1 Intervention

The control arm will receive symptomatic care (acetaminophen 1000mg and ondansetron 4mg). They will not wear any helmets.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Spectrum Health - LakelandLead Sponsor

12 Previous Clinical Trials

1,759 Total Patients Enrolled

Media Library

Catalyst Cryohelmet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05473897 — N/A

Traumatic Brain Injury Clinical Trial 2023: Catalyst Cryohelmet Highlights & Side Effects. Trial Name: NCT05473897 — N/A

Catalyst Cryohelmet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05473897 — N/A

Traumatic Brain Injury Research Study Groups: Control: symptomatic care arm, Catalyst Cryohelmet intervention with symptomatic care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper bound for participant enrolment in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical research has been actively recruiting since its June 23rd 2022 post date and is currently seeking 40 individuals from a single site."

Answered by AI

Are there any opportunities available for people to participate in this research experiment?

"According to information accessible through clinicaltrials.gov, this medical trial began enrolling on June 23rd 2022 and has since been updated in July of the same year. Therefore, recruitment is still active."

Answered by AI

Do I meet the requirements to join this research experiment?

"This research is admitting 40 participants aged 19 to 65 that have experienced traumatic brain injury (TBI). In addition, the patient's main complaint must be related to headache, head trauma or concussion and they must present a Glasgow Coma Scale score of more than 13 on arrival."

Answered by AI