RecruitingNot ApplicableNCT06929923

Pro-2-Cool Pivotal Trial II

A Double-Blind, Randomized Study of Clinical Efficacy of Hypothermic Therapy Following Concussion in Adolescent Athletes as Compared to a Sham-Controlled Population

Sponsor

TecTraum Inc.

Enrollment

66 participants

Start Date

Feb 20, 2025

Study Type

INTERVENTIONAL

Conditions

Concussion, Mild

Summary

This study is being conducted to determine the clinical safety and efficacy of Pro-2-Cool mediated head and neck cooling when applied after concussion and improved symptomatology among adolescent athletes as quantified by post-concussion symptom severity (PCSS) score.

Eligibility

Min Age: 13 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Pro2Cool Device and Sham Cooling Garment Device for people with concussion, mild. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 13 Years to 21 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPro2Cool Device

The Pro2Cool Device is a non-invasive hypothermic therapy ("cold therapy") device that provides localized cooling of the head and neck. Water and isopropyl alcohol cooled to 6°C by the chiller assembly circulate through the cooling garment to create conductive heat transfer from the scalp and carotid arteries, thus achieving cooling of the brain.

DEVICESham Cooling Garment Device

The sham cooling garment device will be placed with impaired cooling function (only to the head), with sham treatment temperature being set to 19°C (instead of the therapeutic 6°C specification). There will be no thermal nylon barrier that will be used and flow to the neck bladder will be closed.