Cooling Helmets to Decrease Concussion Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Head and Neck Cooling as an Emergency Department Therapy to Decrease Progression of Concussive Symptoms

Conditions
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Concussion, Mild, TBI (Traumatic Brain Injury)

Intervention / Treatment
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* Device: Catalyst Cryohelmet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catalyst Cryohelmet intervention with symptomatic care<br>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. | Device: Catalyst Cryohelmet<br>* 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.<br>|
| No Intervention: Control: symptomatic care arm<br>The control arm will receive symptomatic care (acetaminophen 1000mg and ondansetron 4mg). They will not wear any helmets. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Concussion Symptom Severity Score Index case report form | Initial Survey of symptoms within the first 24 hours of injury before intervention Survey Title: Case Report Form: Post-Concussion Symptom Severity Score Index Where ratings range from 0-6: 0 as no symptoms, 1-2 as mild, 2-3 moderate and 5-6 severe The following symptoms will be quantitated: headache, nausea, vomiting, balance problems, dizziness, visual problems, fatigue, sensitivity to light, sensitivity to noise, numbness or tingling, pain other than headache, feeling as if in a fog, feeling slowed down, difficulty concentrating, difficulty remembering, drowsiness, sleeping less than usual, sleeping more than usual, trouble falling asleep, more emotional than usual, irritability, sadness, and nervousness | 0 hour | 
| Post-Concussion Symptom Severity Score Index case report form | Survey 1 hour after the initial survey is performed. This is approximately 30 min post-cooling helmet with medications (interventional arm) or 1hr after medications are administered (control arm). Survey Title: Case Report Form: Post-Concussion Symptom Severity Score Index Where ratings range from 0-6: 0 as no symptoms, 1-2 as mild, 2-3 moderate and 5-6 severe The following symptoms will be quantitated: headache, nausea, vomiting, balance problems, dizziness, visual problems, fatigue, sensitivity to light, sensitivity to noise, numbness or tingling, pain other than headache, feeling as if in a fog, feeling slowed down, difficulty concentrating, difficulty remembering, drowsiness, sleeping less than usual, sleeping more than usual, trouble falling asleep, more emotional than usual, irritability, sadness, and nervousness | 1 hour | 
| Post-Concussion Symptom Severity Score Index case report form | 48 hours after the injury has occurred the volunteer reports their symptoms using the Post-concussion symptom severity score index Survey Title: Case Report Form: Post-Concussion Symptom Severity Score Index Where ratings range from 0-6: 0 as no symptoms, 1-2 as mild, 2-3 moderate and 5-6 severe. The following symptoms will be quantitated: headache, nausea, vomiting, balance problems, dizziness, visual problems, fatigue, sensitivity to light, sensitivity to noise, numbness or tingling, pain other than headache, feeling as if in a fog, feeling slowed down, difficulty concentrating, difficulty remembering, drowsiness, sleeping less than usual, sleeping more than usual, trouble falling asleep, more emotional than usual, irritability, sadness, and nervousness | 48 hours | 
| Post-Concussion Symptom Severity Score Index case report form | 72 hours after the injury has occurred the volunteer reports their symptoms using the Post-concussion symptom severity score index Survey Title: Case Report Form: Post-Concussion Symptom Severity Score Index Where ratings range from 0-6: 0 as no symptoms, 1-2 as mild, 2-3 moderate and 5-6 severe The following symptoms will be quantitated: headache, nausea, vomiting, balance problems, dizziness, visual problems, fatigue, sensitivity to light, sensitivity to noise, numbness or tingling, pain other than headache, feeling as if in a fog, feeling slowed down, difficulty concentrating, difficulty remembering, drowsiness, sleeping less than usual, sleeping more than usual, trouble falling asleep, more emotional than usual, irritability, sadness, and nervousness | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Effects from medication | Including development of adverse effects related to medication administration | From ED Admission to Discharge. From 1 hour up to 6 hours. | 
| Any other medications given during the Emergency Department (ED) stay | Any other medications besides Zofran and Tylenol given during the stay in the ED | From ED Admission to Discharge. From 1 hour up to 6 hours. | 
| Patient Returns to Baseline Function of 0 by 1 hour survey | Scores 0 (zero) on survey questionnaire | 1 hour | 
| Patient Returns to Baseline Function of 0 by 48 hour survey | Scores 0 (zero) on survey questionnaire | 48 hours | 
| Patient Returns to Baseline Function of 0 by 72 hour survey | Scores 0 (zero) on survey questionnaire | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Concussion, mbi, emergency medicine, catalyst cryohelmet, cooling helmet