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Pro-2-Cool Device Clinical Study

Sponsor
TecTraum Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03511339
Collaborator
Bright Research Partners (Industry), Akron Children's Hospital (Other)
174
Enrollment
5
Locations
2
Arms
58.9
Anticipated Duration (Months)
34.8
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: TecTraum device
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Nov 4, 2017
Actual Primary Completion Date :
Apr 27, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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 Names:
  • Pro-2-Cool

    		•

    Outcome Measures

    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. [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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 21 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan - Michigan Medicine Ann Arbor Michigan United States 48108
    2 Akron Children's Hospital Akron Ohio United States 44308-1062
    3 Akron Children's Hospital, Mahoning Valley Campus Boardman Ohio United States 44512
    4 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    5 Dayton Children's Hospital Dayton Ohio United States 45404

    Sponsors and Collaborators

    • TecTraum Inc.
    • Bright Research Partners
    • Akron Children's Hospital

    Investigators

    • Principal Investigator: Joseph Congeni, MD, Akron Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    TecTraum Inc.
    ClinicalTrials.gov Identifier:
    NCT03511339
    Other Study ID Numbers:
    • 1289670
    First Posted:
    Apr 27, 2018
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by TecTraum Inc.
    Concussion
    TBI
    mTBI
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Brain Concussion

    Study Results

    No Results Posted as of May 10, 2022