Cooling Helmets to Decrease Concussion Symptoms (ColdCon)

Spectrum Health - Lakeland

Status: Enrolling

Conditions: Concussion, Mild; TBI (Traumatic Brain Injury)

Treatments: Device: Catalyst Cryohelmet

Study type: Interventional

Funder types: Other

Identifiers

NCT05473897

LHIRB #1613

Details and patient eligibility

About

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.

Full description

There are limited studies that show head-neck cooling used as a treatment for mild TBI. Increased brain temperature can be a secondary injury result in TBI. For every degree raise in temperature, the brain's demand for oxygen and glucose increases by 6 to 10%. This elevated body temperature is associated with a worse outcome in acute brain injuries like strokes or intracerebral hemorrhages. The research hypothesize is that using head-neck cooling in the acute setting of a mild TBI may decrease the overall symptomatic period following an injury.

This research protocol will utilize a randomized controlled trial, with an interventional treatment arm and a control arm, and primary endpoints revolving around patients' post-concussion symptom severity scores. The treatment arm will receive symptomatic care (see Interventions section below) along with 30 minutes of head-neck cooling in the emergency department while being monitored for side effects. The control arm will receive symptomatic care. 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 index score of adults who present after a head injury. In addition, patients will receive Tylenol 500mg twice daily as well as ondansetron 4mg up to twice daily. The Catalyst Cryohelmet will be used to provide head and neck cooling. It comes in three sizes based on head circumference. Once informed consent is obtained then the patient's head will be measured to provide the correct Helmet size. The Cold Packs will be stored in the emergency department freezer and applied to the helmet once the helmet is ready to be applied. The Cryohelmet will be washed between uses. The Catalyst Cryohelmet is registered with the FDA as D344812. It is a Class I (minimal risk) device not requiring pre-marketing or regulatory processes.

Anticipated secondary outcomes include but are not limited to adverse effects relating to application of the head-neck cooling, need for further intervention in the emergency department, and return to baseline function within 72 hours.

Enrollment: 40 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presenting chief complaint of headache, head injury, or concussion within the first 24 hours of injury.
• Glasgow Coma Scale (GCS) > 13 on arrival.

Exclusion criteria

• Age < 19 years or > 65 years
• Inability to provide informed consent
• Vomiting > 2 episodes following injury
• Physical or mental disability hindering adequate response to assessment of symptoms
• Hemodynamic instability/medical condition requiring further acute life-saving medical intervention
• Known brain mass, intracranial hemorrhage, skull fracture
• Scalp abnormalities including laceration or bleeding
• Presence of ventriculoperitoneal (VP) shunt
• Known hematological malignancies, including, but not limited to: multiple myeloma, leukemia, and lymphoma
• Known history of compromised liver function, cold agglutination, cold sensitivity, cryoglobulinemia, 4
• cryofibrinogenemia, and/or a history of severe migraines
• Known contraindication to ondansetron use
• Pregnant patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Catalyst Cryohelmet intervention with symptomatic care

Experimental group

Description:

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.

Treatment:

Device: Catalyst Cryohelmet

Control: symptomatic care arm

No Intervention group

Description:

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