Concussion, MildColdConNCT05473897
Cooling Helmets to Decrease Concussion Symptoms
A study testing Catalyst Cryohelmet in people with Concussion, Mild and TBI (Traumatic Brain Injury), run by Corewell Health South at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Concussion, Mild, TBI (Traumatic Brain Injury)
- What is being tested?
- Catalyst Cryohelmet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting chief complaint of headache, head injury, or concussion within the first 24 hours of injury.
- Glasgow Coma Scale (GCS) > 13 on arrival.
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Spectrum Health Lakeland
Saint Joseph, Michigan, 49085
About this study
Official title: Head and Neck Cooling as an Emergency Department Therapy to Decrease Progression of Concussive Symptoms
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.
Read the 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.
- Conditions
- Concussion, Mild, TBI (Traumatic Brain Injury)
- Being tested
- Catalyst Cryohelmet
- Keywords
- Concussion, mbi, emergency medicine, catalyst cryohelmet, cooling helmet
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catalyst CryohelmetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 72 hours
Secondary outcomes (5)
Adverse Effects from medication
Including development of adverse effects related to medication administration
Measured: 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
Measured: 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
Measured: 1 hour
Patient Returns to Baseline Function of 0 by 48 hour survey
Scores 0 (zero) on survey questionnaire
Measured: 48 hours
Patient Returns to Baseline Function of 0 by 72 hour survey
Scores 0 (zero) on survey questionnaire
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start23 Jun 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Why it stopped: Not able to recruit enough patients; many patients lost to follow up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health South
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473897
- Sponsor's protocol ID
- LHIRB #1613
- Acronym
- ColdCon
- Status last verified
- Nov 2024
- First submitted
- 23 Jun 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: These data will not be shared with other researchers
Publications
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.
PubMed 28198194Guskiewicz 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.
PubMed 16239884Boake 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.
PubMed 16179657Gibson 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.
PubMed 23758286Fox 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.
PubMed 20650030Sahuquillo 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.
PubMed 17692002Congeni 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.
PubMed 34009790Gard 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.
PubMed 34084556King 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head and Neck Cooling as an Emergency Department Therapy to Decrease Progression of Concussive Symptoms
- ClinicalTrials.gov ID
- NCT05473897
- Acronym / sponsor ID
- ColdCon / LHIRB #1613
- Conditions
- Concussion, Mild, TBI (Traumatic Brain Injury)
- Keywords
- Concussion, mbi, emergency medicine, catalyst cryohelmet, cooling helmet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not able to recruit enough patients; many patients lost to follow up
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Corewell Health SouthUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Catalyst Cryohelmet intervention with symptomatic care | Experimental | Device: Catalyst CryohelmetThe 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. |
| Control: symptomatic care arm | No intervention | –The control arm will receive symptomatic care (acetaminophen 1000mg and ondansetron 4mg). They will not wear any helmets. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presenting chief complaint of headache, head injury, or concussion within the first 24 hours of injury.
- Glasgow Coma Scale (GCS) > 13 on arrival.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catalyst CryohelmetThe 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. | Device | Catalyst Cryohelmet intervention with symptomatic care |
Primary outcome
Post-Concussion Symptom Severity Score Index case report form
Time frame: 0 hour
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
Post-Concussion Symptom Severity Score Index case report form
Time frame: 1 hour
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
Post-Concussion Symptom Severity Score Index case report form
Time frame: 48 hours
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
Post-Concussion Symptom Severity Score Index case report form
Time frame: 72 hours
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
5 secondary outcomes
Adverse Effects from medication
Time frame: From ED Admission to Discharge. From 1 hour up to 6 hours.
Any other medications given during the Emergency Department (ED) stay
Time frame: From ED Admission to Discharge. From 1 hour up to 6 hours.
Patient Returns to Baseline Function of 0 by 1 hour survey
Time frame: 1 hour
Patient Returns to Baseline Function of 0 by 48 hour survey
Time frame: 48 hours
Patient Returns to Baseline Function of 0 by 72 hour survey
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Not able to recruit enough patients; many patients lost to follow up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 28198194Vollmer 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.
- Background: PubMed 16239884Guskiewicz 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.
- Background: PubMed 16179657Boake 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.
- Background: PubMed 23758286Gibson 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.
- Background: PubMed 20650030Fox 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.
- Background: PubMed 17692002Sahuquillo 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.
- Background: PubMed 34009790Congeni 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.
- Background: PubMed 34084556Gard 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.
- BackgroundKing 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
- Individual participant dataSharing planned: No. These data will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catalyst Cryohelmet in people with Concussion, Mild and TBI (Traumatic Brain Injury), run by Corewell Health South at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not able to recruit enough patients; many patients lost to follow up). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Concussion Symptom Severity Score Index case report form (time frame: 0 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473897, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.