TecTraum Inc.
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.
This is a multi-center, prospective, randomized, double-blinded, dual-arm comparative study enrolling up to a total of 66 patients (approximately 33 patients in the treatment arm and 33 patients in the control arm) following sports-related, concussion.
Inclusion Criteria: 1. Males and females, 13-21 years of age 2. Confirmed concussion diagnosis consistent with American Congress Rehabilitation Medicine guidelines 21, without any of the following: * Glasgow Coma Scale (GCS) score of less than 13 at 30 minutes post-injury * Loss of consciousness greater than 30 minutes * Post-traumatic amnesia lasting over 24 hours 3. Glasgow Coma Scale (GCS) ≥ 13 at the time of initial injury for study enrollment. 4. Post-Concussion Symptom Scale Score minimum of 15 5. Initial provider visit is within 7 days of injury 6. In generally good health as…
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.
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.
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