SUSPENDED

Pro-2-Cool Pivotal Trial II

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Conditions

Mild Traumatic Brain InjuryNon-invasive hypothermic therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-20
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT06929923

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.

Ages Eligible for Study:12 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males and females ages 12 - 21 years
  2. 2. Initial provider visit is within 8 days of mTBI injury
  3. 3. Confirmed mTBI diagnosis from sporting activities
  4. 4. In generally good health as confirmed by medical history and as determined by site investigator
  5. 5. Has a symptom score of at least 7 (analogous of the SCAT5 symptoms score)
  6. 6. Has informed consent obtained per protocol and as required per IRB
  1. 1. Cleared to return to play during initial visit
  2. 2. Suffers a serious TBI as evidenced by worsening symptoms, specifically:
  3. 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
  4. 3. Sustains another head or neck injury at the time of mTBI injury which requires medical treatment
  5. 4. History of a serious medical or psychiatric disorder that include:
  6. 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
  7. 5. History of Reynaud's disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
  8. 6. Previously diagnosed with a cerebrovascular disorder
  9. 7. Is unable to understand the study requirements or the informed consent
  10. 8. Currently enrolled in another investigational research study that may confound the results of this study
  11. 9. Non-English speaking subjects and parents/legal guardians

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States
Akron Children's Hospital
Akron, Ohio, 44308
United States

Collaborators and Investigators

Sponsor: TecTraum Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-20
Study Completion Date2026-02

Study Record Updates

Study Start Date2025-02-20
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • Non-invasive hypothermic therapy

Additional Relevant MeSH Terms

  • Mild Traumatic Brain Injury