Pro-2-Cool Device Clinical Study

Study Overview
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Brief Summary
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This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling when applied up to 8 days after mild traumatic brain injury (mTBI) among adolescents participating in sporting activities.

Detailed Description
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This is a single-center, prospective, randomized, non-blinded, dual-arm comparator study that will include two-phases, the 60-patient pilot study (30 patients in the treatment arm and 30 patients in the control arm) followed by a pivotal study (up to 200 patients in the treatment and control arm combined) for a total of up to 260 patients overall in both phases. The pilot study will serve as an opportunity to assess the protocol and make adjustments, if necessary. In addition, descriptive statistics including effect size will be calculated and the safety of the device will be assessed at the conclusion of the pilot study. Subjects will be assigned to study arm based on a block randomization schedule generated a priori. The study sponsor believes that the device and therapeutic treatment that will be evaluated in this study is a non-significant risk (NSR) to the subjects.

Official Title
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Pro-2-Cool Device Clinical Study: 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

Conditions
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Mild Traumatic Brain Injury

Intervention / Treatment
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* Device: TecTraum device


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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Brain rest | |
| Experimental: TecTraum Device<br>Treatment with study device | Device: TecTraum device<br>* A non-invasive hypothermic therapy (cold therapy) TecTraum device that provides localized cooling of the head and neck.<br>* Other names: Pro-2-Cool;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The SCAT5 overall score will be collected at the initial visit in the Sports Medicine Clinic, and compared to follow-up visits throughout the study, with the objective of demonstrating better outcomes in the treatment group compared to the control group. | Formal statistical hypothesis testing will be employed in the evaluation of this endpoint. Additionally, comparisons between treatment groups on the baseline SCAT5 (SCAT5-PRE) will be performed at initial visit (as reported by subject) and at each follow-up (72 hours, 10 days, and 4 weeks) separately to evaluate the time trend in recovery. Individual SCAT5 symptoms, each scored on a scale of 0-6, will also be summarized and compared by treatment group to investigate the effect of treatment on specific symptoms. These comparisons are intended to provide additional information on the pattern of recovery and are not attached to intended labeling claims; however, statistical testing of these endpoints will be accompanied by adjustment for multiplicity using the Hochberg-Holm method. | Change from initial visit to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery time from initial visit, summarized by group and compared in the treatment group to control. | Recovery time from initial visit will be formally evaluated for differences between treatment and control. | Initial visit through earliest follow up where complete recovery is observed, maximum of 4 weeks after initial visit. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Concussion, TBI, mTBI