What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) include symptomatic care, rest, and gradual return to activities. Head and neck cooling, which aims to reduce brain temperature, is being studied as an adjunct treatment for mild TBI. Known side effects of head and neck cooling include patient discomfort from feeling cold, headache, nausea, dry skin, and claustrophobia. These side effects are generally mild. Other common TBI treatments may have side effects such as dizziness, fatigue, and cognitive difficulties, depending on the specific intervention and patient condition.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs or treatments for Traumatic Brain Injury (TBI) that focus on head and neck cooling to reduce brain temperature. Current standard care for mild TBI primarily involves symptomatic treatment, rest, and gradual resumption of activities. While head and neck cooling has shown potential in limited studies, it remains an adjunctive treatment under investigation rather than an FDA-approved therapy.

What other types of research exist?

Promising novel alternatives to head and neck cooling for TBI patients include: 1) Pharmacological agents such as neuroprotective drugs that aim to mitigate secondary brain injury, 2) Advanced monitoring and management of intracranial pressure (ICP) using minimally invasive devices, 3) Stem cell therapy to promote neural repair and regeneration, and 4) Targeted temperature management systems that provide more precise and controlled cooling of specific brain regions. These approaches are under investigation and may offer improved outcomes for TBI patients.

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Cooling Helmets for Concussion (ColdCon Trial)

N/A

Waitlist Available

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

No Placebo-Only Group

Summary

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-Concussion Symptom Severity Score Index case report form

Secondary study objectives

Pharmaceutical Preparations

Patient Returns to Baseline Function of 0 by 1 hour survey

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Traumatic Brain Injury (TBI) include symptomatic care, rest, and gradual return to activity. Head and neck cooling, a treatment being studied, aims to reduce brain temperature, which can help mitigate secondary injury processes such as inflammation and metabolic dysfunction. This cooling effect can decrease the intensity and duration of symptoms, prevent further injury, and promote recovery. Other standard interventions focus on maintaining adequate cerebral perfusion and oxygenation, controlling intracranial pressure, and preventing complications like seizures. These treatments are crucial for improving neurological outcomes and enhancing the overall recovery process for TBI patients.

The evidence for hypothermia as a neuroprotectant in traumatic brain injury.