Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Pro2Cool
Previous Study | Return to List | Next Study

Pro-2-Cool Device Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03511339
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : May 25, 2021
Sponsor:
Collaborators:
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.

Layout table for study information
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
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Contacts
Layout table for location contacts
Contact: Danielle Morgan, CCRP 330-543-3193 pro2cool@akronchildrens.org

Locations
Layout table for location information
United States, Michigan
University of Michigan - Michigan Medicine Recruiting
Ann Arbor, Michigan, United States, 48108
Contact: Lea Franco-MacKendrick    734-763-2200    lmfranco@med.umich.edu   
Principal Investigator: Ingrid Ichesco, MD         
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308-1062
Contact: Danielle Morgan, MACPR    330-543-3193    pro2cool@akronchildrens.org   
Principal Investigator: Joseph Congeni, MD         
Akron Children's Hospital, Mahoning Valley Campus Recruiting
Boardman, Ohio, United States, 44512
Contact: Danielle Morgan, MACPR    330-543-3193    pro2cool@akronchildrens.org   
Principal Investigator: Christopher Liebig, MD         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Christy Reed    513-803-7206    Christy.Reed@cchmc.org   
Principal Investigator: Kelsey Logan, MD         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Donetta Setters-Leach, BSN, RN-NIC    937-641-4369    SettersLeachD@childrensdayton.org   
Principal Investigator: Lora Scott, MD         
Sponsors and Collaborators
TecTraum Inc.
Bright Research Partners
Akron Children's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Joseph Congeni, MD Akron Children's Hospital
Additional Information:
Publications of Results:
Layout table for additonal information
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 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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.:
Concussion
TBI
mTBI
Additional relevant MeSH terms:
Layout table for MeSH terms
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