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Pro-2-Cool Concussion Study

Evaluation of a Cooling Therapy following Concussion in Adolescent Athletes

Description:

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 Hospital 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 threefollow-up visits at Akron Children’s Hospital 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 Payotn Kline or Danielle Morgan. 

Providers: If you are a provider interested in bringing this study to your site, please complete the feasibility questionnaire below.

Who May Qualify?:

Adolescent athletes between the ages of 12-21 years old diagnosed with a concussion.

Who Does Not Qualify:

Students with:

  • History of serious medical or psychiatric disorder

  • History of Reynaud’s disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia

  • Previously diagnosed with a cerebrovascular disorder

  • Known pregnancy

Interested in participating?
We are currently recruiting
Study Sponsor:

TecTraum

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
If you are interested in this study or have questions about your child's eligibility, please contact:

Peyton Kline or Danielle Morgan
330-543-3193

Lead Investigator
Joseph Congeni, MD

Director, Sports Medicine; Sports Medicine Physician
Sports Medicine Center