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

Status: Active, not recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 21
Healthy Volunteers: No
View:

• 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)

Locations
United States
Michigan
University of Michigan - Michigan Medicine
Ann Arbor
Ohio
Akron Children's Hospital
Akron
Akron Children's Hospital, Mahoning Valley Campus
Boardman
Cincinnati Children's Hospital Medical Center
Cincinnati
Dayton Children's Hospital
Dayton
Time Frame
Start Date: November 4, 2017
Estimated Completion Date: October 2022
Participants
Target number of participants: 174
Treatments
No Intervention: Control
Brain rest
Experimental: TecTraum Device
Treatment with study device
Authors
Ingrid Ichesco, Lora Scott, Joseph Congeni, Christopher Liebig, Kelsey Logan
Related Therapeutic Areas
Sponsors
Collaborators: Bright Research Partners, Akron Children's Hospital
Leads: TecTraum Inc.

This content was sourced from clinicaltrials.gov

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