Cooling Helmets for Concussion

(ColdCon Trial)

Overseen By Monique Luna

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spectrum Health - Lakeland

Must not be taking: Ondansetron

Disqualifiers: Age, Vomiting, Disability, Hemodynamic, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1-6 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cooling helmets can improve recovery from mild concussions, a type of mild brain injury. Emergency room visitors with a recent concussion will either receive usual care or try a helmet that cools the head and neck, known as the Catalyst Cryohelmet. The trial aims to determine if the cooling helmet reduces symptoms like headaches and accelerates recovery. Individuals who experienced a concussion within the last 24 hours and are not severely injured may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Catalyst Cryohelmet is safe for treating mild traumatic brain injuries?

Research has shown that cooling the head and neck, such as with the Catalyst Cryohelmet, is safe for people. A study with healthy volunteers found that this cooling method did not cause any harmful side effects. Additionally, research from New Zealand found that using the Cryohelmet greatly reduced symptoms in people with sports-related concussions.

These findings suggest that the Cryohelmet is generally well-tolerated. However, the trial is in an early stage, so more research is needed to fully understand its safety and effectiveness in treating mild traumatic brain injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Catalyst Cryohelmet because it offers a unique approach to treating concussions by combining standard symptomatic care with targeted cooling therapy. Unlike traditional treatments that solely rely on medications like acetaminophen or anti-nausea drugs, the Cryohelmet uses head-neck cooling to potentially reduce symptoms more effectively and quickly. This cooling method may help minimize inflammation and other post-concussion effects, offering a novel mechanism that could enhance recovery compared to current options.

What evidence suggests that the Catalyst Cryohelmet is effective for mild TBI?

Research has shown that cooling the head and neck can aid recovery from mild traumatic brain injuries, such as concussions. In this trial, one group of participants will receive symptomatic care along with the use of the Catalyst Cryohelmet for head-neck cooling. One study found that the Catalyst Cryohelmet quickly reduced concussion symptoms after a head injury. This cooling method appears to lessen symptom severity and may speed up recovery. Another study showed that cooling helmets decreased both the number and severity of symptoms after a sports-related concussion. These findings suggest that the Catalyst Cryohelmet could effectively reduce symptoms following a concussion. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Glasgow Coma Scale (GCS) > 13 on arrival

I have had a headache or head injury in the last 24 hours.

Exclusion Criteria

Presence of ventriculoperitoneal (VP) shunt

I have vomited more than twice after an injury.

I am younger than 19 or older than 65.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 hours

1 visit (in-person)

Treatment

Participants receive symptomatic care and 30 minutes of head-neck cooling in the emergency department

1-6 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using the Post-Concussion Symptom Severity Score Index

72 hours

Follow-up interviews at different timepoints

What Are the Treatments Tested in This Trial?

Interventions

• Catalyst Cryohelmet

Trial Overview 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.

How Is the Trial Designed?

Group I: Catalyst Cryohelmet intervention with symptomatic care Experimental Treatment 1 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 arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Spectrum Health - Lakeland

Lead Sponsor

Trials

14

Recruited

1,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4936650/

The effect of selective head-neck cooling on physiological and ... The main objective of this study was to examine the effects of head and neck cooling on physiological and cognitive function in normal healthy volunteers.

2. withpower.com withpower.com/trial/phase-brain-concussion-5-2022-e8f91

Cooling Helmets for Concussion (ColdCon Trial) This trial tests if a cooling helmet can help adults with mild traumatic brain injuries recover faster. The helmet cools the head and neck to lower brain ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05473897?keyword=%22Cooling%22

Cooling Helmets to Decrease Concussion Symptoms The main goal of this study is to evaluate if head-neck cooling of 30 minutes within the first 24 hours of a concussion will decrease the symptomatic severity ...

4. prnewswire.com prnewswire.com/news-releases/new-zealand-research-finds-head-and-neck-cooling-with-cryohelmet-significantly-reduces-clinical-symptom-severity-after-sports-related-concussion-injuries-300934514.html

New Zealand Research Finds Head-and-Neck Cooling ... "This study identified an observed and pronounced immediate reduction in post-brain injury event clinical symptoms for both male and female ...

5. cryohelmet.com cryohelmet.com/for-concussions

Concussion Symptom Relief The Catalyst Cryohelmet has been demonstrated by researchers to reduce the number and severity of symptoms after sustaining a sports-related concussion.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03185507

The Effect of Cryotherapy on Cerebral Hemodynamics ... 10-17 Cryotherapy following moderate or severe traumatic brain injury has been demonstrated to decrease intracranial metabolic processes and oxygenation ...