Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
18 participants
INTERVENTIONAL
2022-06-23
2024-04-01
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Catalyst Cryohelmet intervention with symptomatic care
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.
Catalyst Cryohelmet
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.
Control: symptomatic care arm
The control arm will receive symptomatic care (acetaminophen 1000mg and ondansetron 4mg). They will not wear any helmets.
No interventions assigned to this group
Interventions
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Catalyst Cryohelmet
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.
Eligibility Criteria
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Inclusion Criteria
* Glasgow Coma Scale (GCS) \> 13 on arrival.
Exclusion Criteria
* 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
19 Years
65 Years
ALL
No
Sponsors
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Spectrum Health - Lakeland
OTHER
Responsible Party
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Locations
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Spectrum Health Lakeland
Saint Joseph, Michigan, United States
Countries
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References
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Vollmer BL, Kirkwood MW, Comstock RD, Currie D, Grubenhoff JA. Assessing the Clinical Utility of the Question, "Is Your Child/Are You Back to Normal?" in Pediatric Concussion Symptom Resolution. Clin Pediatr (Phila). 2018 Feb;57(2):146-151. doi: 10.1177/0009922817693300. Epub 2017 Feb 15.
Guskiewicz KM, Marshall SW, Bailes J, McCrea M, Cantu RC, Randolph C, Jordan BD. Association between recurrent concussion and late-life cognitive impairment in retired professional football players. Neurosurgery. 2005 Oct;57(4):719-26; discussion 719-26. doi: 10.1093/neurosurgery/57.4.719.
Boake C, McCauley SR, Levin HS, Pedroza C, Contant CF, Song JX, Brown SA, Goodman H, Brundage SI, Diaz-Marchan PJ. Diagnostic criteria for postconcussional syndrome after mild to moderate traumatic brain injury. J Neuropsychiatry Clin Neurosci. 2005 Summer;17(3):350-6. doi: 10.1176/jnp.17.3.350.
Gibson S, Nigrovic LE, O'Brien M, Meehan WP 3rd. The effect of recommending cognitive rest on recovery from sport-related concussion. Brain Inj. 2013;27(7-8):839-42. doi: 10.3109/02699052.2013.775494. Epub 2013 Jun 12.
Fox JL, Vu EN, Doyle-Waters M, Brubacher JR, Abu-Laban R, Hu Z. Prophylactic hypothermia for traumatic brain injury: a quantitative systematic review. CJEM. 2010 Jul;12(4):355-64. doi: 10.1017/s1481803500012471.
Sahuquillo J, Vilalta A. Cooling the injured brain: how does moderate hypothermia influence the pathophysiology of traumatic brain injury. Curr Pharm Des. 2007;13(22):2310-22. doi: 10.2174/138161207781368756.
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.
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.
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
Other Identifiers
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LHIRB #1613
Identifier Type: -
Identifier Source: org_study_id