Pro-2-Cool Device Clinical Study

Mild Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03511339
• Other study ID #: 1289670
• Status: Completed
• Phase: N/A
• Start date: November 4, 2017
• Est. completion date: May 29, 2022

Study information

• Verified date: May 2023
• Source: TecTraum Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: May 29, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Device:
• TecTraum device
A non-invasive hypothermic therapy ("cold therapy") TecTraum device that provides localized cooling of the head and neck.

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio
United States	University of Michigan - Michigan Medicine	Ann Arbor	Michigan
United States	Akron Children's Hospital, Mahoning Valley Campus	Boardman	Ohio
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Dayton Children's Hospital	Dayton	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
TecTraum Inc.	Akron Children's Hospital, Bright Research Partners

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):341-3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from initial visit to 4 weeks
Secondary	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.	Initial visit through earliest follow up where complete recovery is observed, maximum of 4 weeks after initial visit.

External Links

•   Akron Children's Hospital clinical study information for potential participants.
•   TecTraum website with video describing trial.