Cooling Helmets to Decrease Concussion Symptoms

NCT05473897 | Terminated FDA Device

• 1 other identifier: LHIRB #1613
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild; TBI (Traumatic Brain Injury)

Keywords

Concussion; mbi; emergency medicine; catalyst cryohelmet; cooling helmet

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Adverse Effects from medication

  From ED Admission to Discharge. From 1 hour up to 6 hours.

• Any other medications given during the Emergency Department (ED) stay

  From ED Admission to Discharge. From 1 hour up to 6 hours.

• Patient Returns to Baseline Function of 0 by 1 hour survey

  1 hour

• Patient Returns to Baseline Function of 0 by 48 hour survey

  48 hours

• Patient Returns to Baseline Function of 0 by 72 hour survey

  72 hours

Study Arms (2)

Catalyst Cryohelmet intervention with symptomatic care

EXPERIMENTAL

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

Control: symptomatic care arm

NO INTERVENTION

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

Interventions

Catalyst Cryohelmet DEVICE

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.

Catalyst Cryohelmet intervention with symptomatic care

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health South: lead

Study Sites (1)

Spectrum Health Lakeland

Saint Joseph, Michigan, 49085, United States

Location

Related Publications (9)

• 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.

  PMID: 28198194 BACKGROUND

• 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.

  PMID: 16239884 BACKGROUND

• 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.

  PMID: 16179657 BACKGROUND

• 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.

  PMID: 23758286 BACKGROUND

• 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.

  PMID: 20650030 BACKGROUND

• 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.

  PMID: 17692002 BACKGROUND

• 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.

  PMID: 34009790 BACKGROUND

• 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.

  PMID: 34084556 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 26, 2022
• Study Start: June 23, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)