Clinical trial NCT05473897: Cooling Helmets to Decrease Concussion Symptoms
Official title: Head and Neck Cooling as an Emergency Department Therapy to Decrease Progression of Concussive Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Concussion, Mild
TBI (Traumatic Brain Injury)
Keywords: Concussion
mbi
emergency medicine
catalyst cryohelmet
cooling helmet
Lead sponsor: Spectrum Health - Lakeland
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-Concussion Symptom Severity Score Index case report form
timeFrame: 0 hour
measure: Post-Concussion Symptom Severity Score Index case report form
timeFrame: 1 hour
measure: Post-Concussion Symptom Severity Score Index case report form
timeFrame: 48 hours
measure: Post-Concussion Symptom Severity Score Index case report form
timeFrame: 72 hours
Secondary outcomes:
measure: Adverse Effects from medication
timeFrame: From ED Admission to Discharge. From 1 hour up to 6 hours.
measure: Any other medications given during the Emergency Department (ED) stay
timeFrame: From ED Admission to Discharge. From 1 hour up to 6 hours.
measure: Patient Returns to Baseline Function of 0 by 1 hour survey
timeFrame: 1 hour
measure: Patient Returns to Baseline Function of 0 by 48 hour survey
timeFrame: 48 hours
measure: Patient Returns to Baseline Function of 0 by 72 hour survey
timeFrame: 72 hours
Other outcomes:
Locations:
city: Saint Joseph
country: United States
facility: Spectrum Health Lakeland
state: Michigan
Study officials:
References:
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citation: Congeni J, Murray T, Kline P, Bouhenni R, Morgan D, Liebig C, Lesak A, McNinch NL. Preliminary Safety and Efficacy of Head and Neck Cooling Therapy After Concussion in Adolescent Athletes: A Randomized Pilot Trial. Clin J Sport Med. 2022 Jul 1;32(4):341-347. doi: 10.1097/JSM.0000000000000916. Epub 2021 Mar 10.
citation: Gard A, Tegner Y, Bakhsheshi MF, Marklund N. Selective head-neck cooling after concussion shortens return-to-play in ice hockey players. Concussion. 2021 Apr 15;6(2):CNC90. doi: 10.2217/cnc-2021-0002.
citation: King K, Hume PA, Hind K, Clark T. Effect of Selective Head-Neck Cooling on Signs and Symptoms of Sport Originated Brain Injury in Amateur Sports: A Pilot Study. BJSTR 21(4):16062-70