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Trial record 1 of 1 for:    Pro2Cool
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Pro-2-Cool Device Clinical Study

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ClinicalTrials.gov Identifier: NCT03511339
Recruitment Status : Active, not recruiting
First Posted : April 27, 2018
Last Update Posted : May 10, 2022
Bright Research Partners
Akron Children's Hospital
Information provided by (Responsible Party):
TecTraum Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Device: TecTraum device Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 4, 2017
Actual Primary Completion Date : April 27, 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
Brain rest
Experimental: TecTraum Device
Treatment with study device
Device: TecTraum device
A non-invasive hypothermic therapy ("cold therapy") TecTraum device that provides localized cooling of the head and neck.
Other Name: Pro-2-Cool

Primary Outcome Measures :
  1. 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. [ Time Frame: Change from initial visit to 4 weeks ]

    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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511339

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United States, Michigan
University of Michigan - Michigan Medicine
Ann Arbor, Michigan, United States, 48108
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308-1062
Akron Children's Hospital, Mahoning Valley Campus
Boardman, Ohio, United States, 44512
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Sponsors and Collaborators
TecTraum Inc.
Bright Research Partners
Akron Children's Hospital
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Principal Investigator: Joseph Congeni, MD Akron Children's Hospital
Additional Information:
Publications of Results:
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Responsible Party: TecTraum Inc.
ClinicalTrials.gov Identifier: NCT03511339    
Other Study ID Numbers: 1289670
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by TecTraum Inc.:
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating