Reduced Concussion Symptom Burden in Early Adolescent Athletes Using a Head-Neck Cooling Device

To determine whether an investigational head-neck cooling device, Pro2cool, can better reduce symptom severity compared with standard postconcussion care in early adolescent athletes after a sports-related concussion. Prospective, longitudinal, randomized trial design conducted over a 28-day period....

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Published inClinical journal of sport medicine Vol. 34; no. 3; p. 247
Main Authors Smith, Matthew A, McNinch, Neil L, Chaney, Danielle, Shauver, Lisa, Murray, Tamara, Kline, Peyton, Lesak, Alexandria, Franco-MacKendrick, Lea, Scott, Lora, Logan, Kelsey, Ichesco, Ingrid K, Liebig, Christopher, Congeni, Joseph
Format Journal Article
LanguageEnglish
Published United States 01.05.2024
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Abstract To determine whether an investigational head-neck cooling device, Pro2cool, can better reduce symptom severity compared with standard postconcussion care in early adolescent athletes after a sports-related concussion. Prospective, longitudinal, randomized trial design conducted over a 28-day period. Six pediatric medical centers in Ohio and Michigan. The study enrolled 167 male and female 12- to 19-year-old athletes who experienced a sports-related concussion within 8 days of study enrollment and registering a Sports Concussion Assessment Tool 5 (SCAT5) composite score >7. Pro2cool, an investigational head-neck cooling therapy device, was applied at 2 postinjury time points compared with postconcussion standard of care only. Baseline SCAT5 composite symptom severity scores were determined for all subjects. Sports Concussion Assessment Tool 5 scores for concussed athletes receiving cooling treatment were analyzed across 6 independent postenrollment time points compared with subjects who did not receive cooling therapy and only standard care. Adverse reactions and participate demographics were also compared. Athletes who received Pro2cool cooling therapy (n = 79) experienced a 14.4% greater reduction in SCAT5 symptom severity scores at the initial visit posttreatment, a 25.5% greater reduction at the 72-hour visit posttreatment, and a 3.4% greater reduction at the 10-day visit compared with subjects receiving only standard care (n = 88). Overall, 36 adverse events (increased blood pressure, decreased pulse, and dizziness) were reported, with 13 events associated with the device, of which 3 were classified as moderate in severity. This study demonstrates the efficacy and safety of head and neck cooling for the management of concussion symptoms in adolescent athletes of an age group for which little to no prior data are available.
AbstractList To determine whether an investigational head-neck cooling device, Pro2cool, can better reduce symptom severity compared with standard postconcussion care in early adolescent athletes after a sports-related concussion. Prospective, longitudinal, randomized trial design conducted over a 28-day period. Six pediatric medical centers in Ohio and Michigan. The study enrolled 167 male and female 12- to 19-year-old athletes who experienced a sports-related concussion within 8 days of study enrollment and registering a Sports Concussion Assessment Tool 5 (SCAT5) composite score >7. Pro2cool, an investigational head-neck cooling therapy device, was applied at 2 postinjury time points compared with postconcussion standard of care only. Baseline SCAT5 composite symptom severity scores were determined for all subjects. Sports Concussion Assessment Tool 5 scores for concussed athletes receiving cooling treatment were analyzed across 6 independent postenrollment time points compared with subjects who did not receive cooling therapy and only standard care. Adverse reactions and participate demographics were also compared. Athletes who received Pro2cool cooling therapy (n = 79) experienced a 14.4% greater reduction in SCAT5 symptom severity scores at the initial visit posttreatment, a 25.5% greater reduction at the 72-hour visit posttreatment, and a 3.4% greater reduction at the 10-day visit compared with subjects receiving only standard care (n = 88). Overall, 36 adverse events (increased blood pressure, decreased pulse, and dizziness) were reported, with 13 events associated with the device, of which 3 were classified as moderate in severity. This study demonstrates the efficacy and safety of head and neck cooling for the management of concussion symptoms in adolescent athletes of an age group for which little to no prior data are available.
Author Liebig, Christopher
McNinch, Neil L
Lesak, Alexandria
Chaney, Danielle
Ichesco, Ingrid K
Kline, Peyton
Scott, Lora
Congeni, Joseph
Murray, Tamara
Shauver, Lisa
Smith, Matthew A
Franco-MacKendrick, Lea
Logan, Kelsey
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  organization: Department of Sports Medicine, Akron Children's Hospital, Akron, Ohio
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Snippet To determine whether an investigational head-neck cooling device, Pro2cool, can better reduce symptom severity compared with standard postconcussion care in...
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StartPage 247
SubjectTerms Adolescent
Athletic Injuries - diagnosis
Athletic Injuries - therapy
Brain Concussion - diagnosis
Brain Concussion - therapy
Child
Female
Humans
Hypothermia, Induced - instrumentation
Hypothermia, Induced - methods
Longitudinal Studies
Male
Prospective Studies
Symptom Burden
Young Adult
Title Reduced Concussion Symptom Burden in Early Adolescent Athletes Using a Head-Neck Cooling Device
URI https://www.ncbi.nlm.nih.gov/pubmed/38180057
Volume 34
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