A Double-Blind, Randomized Study of Clinical Efficacy of Hypothermic Therapy Following Concussion in Adolescent Athletes as Compared to a Sham-Controlled Population
TecTraum Inc.
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.
Description
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.
Eligibility
- Age range
- 13–21 years
- Sex
- All
- Healthy volunteers
- No
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…
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.
Locations (3)
- University of MichiganAnn Arbor, Michigan
- Akron Children's HospitalAkron, Ohio
- Cleveland Clinic FoundationCleveland, Ohio