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Pro-2-Cool Pivotal Trial II

Description

This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling, using the Pro-2-Cool device, when applied after mTBI injury sustained by adolescents aged 12-21 years, participating in sporting activities.

Conditions

Mild Traumatic Brain Injury
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Related Conditions:

Mild Traumatic Brain Injury

Study Overview

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Study Details

Study overview

This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling, using the Pro-2-Cool device, when applied after mTBI injury sustained by adolescents aged 12-21 years, participating in sporting activities.

An Assessment of Clinical Efficacy of Hypothermic Therapy Following Mild Traumatic Brain Injury (mTBI) in the Adolescent Athlete as Compared to an Untreated Active Control Population

Pro-2-Cool Pivotal Trial II

Condition
Mild Traumatic Brain Injury
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Akron

Akron Children's Hospital, Akron, Ohio, United States, 44308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Males and females ages 12 - 21 years
  • 2. Initial provider visit is within 8 days of mTBI injury
  • 3. Confirmed mTBI diagnosis from sporting activities
  • 4. In generally good health as confirmed by medical history and as determined by site investigator
  • 5. Has a symptom score of at least 7 (analogous of the SCAT5 symptoms score)
  • 6. Has informed consent obtained per protocol and as required per IRB
  • 1. Cleared to return to play during initial visit
  • 2. Suffers a serious TBI as evidenced by worsening symptoms, specifically:
  • 2.1. GCS \<14 2.2. Seizure 2.3. Hospitalization 2.4. Existing positive diagnostic testing which include radiology scans that indicate brain bleed 2.5. Slurred speech, which has not resolved within 72 hours of mTBI injury
  • 3. Sustains another head or neck injury at the time of mTBI injury which requires medical treatment
  • 4. History of a serious medical or psychiatric disorder that include:
  • 4.1. Suicide attempt in the last 6 months 4.2. Unmanaged depression or anxiety 4.3. Hospitalization in the last 6 months for psychiatric treatment
  • 5. History of Reynaud's disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
  • 6. Previously diagnosed with a cerebrovascular disorder
  • 7. Is unable to understand the study requirements or the informed consent
  • 8. Currently enrolled in another investigational research study that may confound the results of this study
  • 9. Non-English speaking subjects and parents/legal guardians

Ages Eligible for Study

12 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

TecTraum Inc.,

Brian Reilly, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center of Akron

Study Record Dates

2026-02