Pro-2-Cool Pivotal Trial II

TecTraum Inc.72 enrolled

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.

This is a multi-center, prospective, randomized, non-blinded, dual-arm comparator study enrolling up to a total of 72 patients (approximately 36 patients in the treatment arm and 36 patients in the control arm) following sports-related, mTBI.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mild Traumatic Brain Injury

Interventions

Pro-2-Cool DeviceDEVICE

The Pro-2-Cool Device is a non-invasive hypothermic therapy ("cold therapy") device that provides localized cooling of the head and neck. Water and isopropyl alcohol cooled to 6°C by the chiller assembly circulate through the cooling garment to create conductive heat transfer from the scalp and carotid arteries, thus achieving cooling of the brain.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 21 Years

Medical Language ↔ Plain English

Inclusion 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 Exclusion Criteria: 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

Locations (2)

University of Michigan

Ann Arbor, Michigan, United States

Akron Children's Hospital

Akron, Ohio, United States

Outcomes

Primary Outcomes

SCAT-5 change from baseline to the post-72 hour follow-up visit measurement

Sport Concussion Assessment Tool 5th edition (SCAT-5) is the current standard of practice assessment tool used at the time of injury to diagnose an mTBI.

Time frame: Baseline to 72-hour follow-up

Data from ClinicalTrials.gov

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