Pro-2-Cool Device Clinical Study

May 1, 2023 updated by: TecTraum Inc.

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • University of Michigan - Michigan Medicine
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • Akron Children's Hospital
      • Boardman, Ohio, United States, 44512
        • Akron Children's Hospital, Mahoning Valley Campus
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Dayton, Ohio, United States, 45404
        • Dayton Children's Hospital

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.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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.
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.

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.
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.
Initial visit through earliest follow up where complete recovery is observed, maximum of 4 weeks after initial visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 Major Dates

Study Start (Actual)

November 4, 2017

Primary Completion (Actual)

April 27, 2022

Study Completion (Actual)

May 29, 2022

Study Registration Dates

First Submitted

March 30, 2018

First Submitted That Met QC Criteria

April 17, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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