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Protocool Concussion Study

Evaluation of a Cooling Therapy following Concussion in High School 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. Student athletes will be recruited from participating high schools in Northeast Ohio. Schools will be randomized each sport season to receive either brain rest or the cooling therapy.  Student athletes will be consented prior to the season, and still complete an ImPACT computer test, a symptom score sheet, and a brief head trauma history from prior to injury.  After an athlete experiences a concussion, they are required to complete a minimum of four follow-up visits at Akron Children's Hospital Sports Medicine Clinic, at 72 hours, 2 weeks, 4 weeks and 12 weeks.

Recruitment inquiry form

Watch the study video

Who May Qualify?:

Student athletes in participating high schools between the ages of 14-19 years old.

Participating high schools:

Archbishop Hoban
Buchtel
East
Ellet
Field
Firestone
Kenmore-Garfield
Mogadore
Rootstown
St. Vincent – St. Mary
Woodridge

Who Does Not Qualify:

Students:

  • with history of a serious medical or psychiatric disorder
  • with a history of Reynaud’s disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
  • previously diagnosed with a cerebrovascular disorder
  • who are pregnant
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 high school athlete as compared to an untreated active control population
IRB Study ID:
1064336-6
If you are interested in this study or have questions about your child's eligibility, please contact:

Alexandria Lesak, MPH
330-543-5727

Lead Investigator
Joseph Congeni, MD

Director, Sports Medicine; Sports Medicine Physician
Sports Medicine Center