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

18 Participants Needed

Trial Summary

What is the purpose of this 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 temperature, potentially reducing symptoms. Patients will be monitored for symptom severity and side effects over a few days. Cooling has been studied as a method to reduce symptoms and pathological changes after concussive injuries.

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 data supports the effectiveness of the treatment Catalyst Cryohelmet for concussions?

Research shows that using a cooling helmet can help reduce brain temperature, which is beneficial for brain protection. In a study with ice hockey players, those who used head-neck cooling after a concussion returned to play faster than those who did not, suggesting the treatment may help speed up recovery. ^{1 2 3 4 5}

Is the cooling helmet safe for use in humans?

Research on head and neck cooling helmets, including those using NASA technology, suggests they are generally safe for humans. Studies have been conducted on athletes with concussions, and no significant safety concerns have been reported. ^{1 2 5 6 7}

How does the Cooling Helmet treatment for concussion differ from other treatments?

The Cooling Helmet treatment is unique because it uses NASA spinoff technology to selectively cool the head and neck, which helps lower brain temperature and protect against further brain damage. This approach is different from systemic cooling methods, which are not practical or safe for mild traumatic brain injuries like concussions. ^{1 2 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Rapid and selective cerebral hypothermia achieved using a cooling helmet. [2007]

2. Germany pubmed.ncbi.nlm.nih.gov

A novel head-neck cooling device for concussion injury in contact sports. [2020]

3. Ireland pubmed.ncbi.nlm.nih.gov

Hypothermia in acute blunt head injury. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Therapeutic hypothermia for head injury. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Shorter Recovery Time in Concussed Elite Ice Hockey Players by Early Head-and-Neck Cooling: A Clinical Trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Preliminary Safety and Efficacy of Head and Neck Cooling Therapy After Concussion in Adolescent Athletes: A Randomized Pilot Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Facial protection and head injuries in ice hockey: a systematic review. [2018]

8. Ireland pubmed.ncbi.nlm.nih.gov

Rapid (0.5 degrees C/min) minimally invasive induction of hypothermia using cold perfluorochemical lung lavage in dogs. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Theoretical evaluations of therapeutic systemic and local cerebral hypothermia. [2009]

10. Germany pubmed.ncbi.nlm.nih.gov

Conduction-Dominated Cryomesh for Organism Vitrification. [2023]