Evaluation of a Cooling Therapy following Concussion in Adolescent Athletes
Full IRB Study Title:
An assessment of clinical efficacy of hypothermic therapy immediately following mild traumatic brain injury (mTBI) in the adolescent athlete as compared to an untreated active control population
IRB Study ID: 1289670
The purpose of this study is to evaluate if cooling the brain after injury is a more effective in concussion treatment than the current standard care of brain rest. Athletes will be recruited from the Sports Medicine Clinic at Akron Children’s in Akron. After signing up for the study, athletes will be randomized to receive either brain rest or the cooling therapy. All participating athletes are required to complete a minimum of three follow-up visits at Akron Children’s Sports Medicine Clinic in Akron (72 hours, 2 weeks and 4 weeks).
Athletes and Parents: If you suspect your athlete has experienced a concussion, please call the Sports Medicine Clinic to schedule an appointment with a provider. During this appointment, the athlete will be evaluated for their injury as well as the clinical trial. At the end of the appointment, you will have the opportunity to sign up, if the athlete is eligible. To schedule an appointment in Akron, please call 330-543-8260. To schedule an appointment in Boardman, please call 330-746-8071 (option 2). For questions regarding eligibility, please the Research Institute as 330-543-3193 and ask for Payton Kline or Danielle Morgan.
Providers: If you are a provider interested in bringing this study to your site, please complete the feasibility questionnaire below.
Study Sponsor:
TecTraum
Resources
Who May Qualify:
Adolescent athletes between the ages of 12-21 years old diagnosed with a concussion.
Who Does NOT Qualify:
Students with:
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History of serious medical or psychiatric disorder
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History of Reynaud’s disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
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Previously diagnosed with a cerebrovascular disorder
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Known pregnancy
Lead Investigator
Joseph Congeni, MD
Physician Liaison for Philanthropy; The Scala Family Endowed Chair in Sports Medicine
