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Pro-2-Cool Device Clinical Study

Primary Purpose

Mild Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TecTraum device
Sponsored by
TecTraum Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring Concussion, TBI, mTBI

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan - Michigan Medicine
  • Akron Children's Hospital
  • Akron Children's Hospital, Mahoning Valley Campus
  • Cincinnati Children's Hospital Medical Center
  • Dayton Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

TecTraum Device

Arm Description

Brain rest

Treatment with study device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 30, 2018
Last Updated
May 1, 2023
Sponsor
TecTraum Inc.
Collaborators
Bright Research Partners, Akron Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03511339
Brief Title
Pro-2-Cool Device Clinical Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 4, 2017 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
May 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TecTraum Inc.
Collaborators
Bright Research Partners, Akron Children's Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
Keywords
Concussion, TBI, mTBI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Brain rest
Arm Title
TecTraum Device
Arm Type
Experimental
Arm Description
Treatment with study device
Intervention Type
Device
Intervention Name(s)
TecTraum device
Other Intervention Name(s)
Pro-2-Cool
Intervention Description
A non-invasive hypothermic therapy ("cold therapy") TecTraum device that provides localized cooling of the head and neck.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Change from initial visit to 4 weeks
Secondary Outcome Measure Information:
Title
Recovery time from initial visit, summarized by group and compared in the treatment group to control.
Description
Recovery time from initial visit will be formally evaluated for differences between treatment and control.
Time Frame
Initial visit through earliest follow up where complete recovery is observed, maximum of 4 weeks after initial visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Congeni, MD
Organizational Affiliation
Akron Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan - Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
Country
United States
Facility Name
Akron Children's Hospital, Mahoning Valley Campus
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34009790
Citation
Congeni J, Murray T, Kline P, Bouhenni R, Morgan D, Liebig C, Lesak A, McNinch NL. Preliminary Safety and Efficacy of Head and Neck Cooling Therapy After Concussion in Adolescent Athletes: A Randomized Pilot Trial. Clin J Sport Med. 2022 Jul 1;32(4):341-347. doi: 10.1097/JSM.0000000000000916. Epub 2021 Mar 10.
Results Reference
result
Links:
URL
https://www.pro-2-cool.com/
Description
TecTraum website with video describing trial.
URL
https://www.akronchildrens.org/clinical-studies/Pro-2-Cool-Concussion-Study.html
Description
Akron Children's Hospital clinical study information for potential participants.

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Pro-2-Cool Device Clinical Study

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