Concussion, Mild
Conditions
Keywords
Non-invasive hypothermic therapy, Sports-related concussion
Brief 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.
Detailed 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.
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.
Sponsors
TecTraum Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
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 confirmed by medical history and determined by site investigator or designated trained healthcare professional under the supervision of the principal investigator. 7. Has informed consent obtained per protocol and as required per Institutional Review Board
Exclusion criteria
1. Age \< 13 years or \> 21 years 2. Inability to understand the study requirements or provide informed consent 3. Cleared to return to play during initial visit 4. Prior participation in a Pro2Cool Clinical Study 5. Serious traumatic brain injury as evidenced by worsening symptoms: * Vomiting \> 2 episodes following injury * Seizure * Hospitalization * Radiology scan indicating brain bleed * Slurred speech which has not resolved within 72 hours of concussive injury 6. Physical (e.g., head or neck injury that requires medical treatment) or mental disability hindering adequate response to assessment of symptoms 7. Hemodynamic instability/medical condition requiring further acute life-saving medical intervention 8. History of psychiatric disorder that includes suicide attempts within the last 6 months, unmanaged depression or anxiety, hospitalization for psychiatric treatment within the last 6 months 9. Known brain mass, intracranial hemorrhage, skull fracture 10. Scalp abnormalities including laceration or bleeding 11. Presence of ventriculoperitoneal (VP) shunt 12. Known hematological malignancies, including, but not limited to: multiple myeloma, leukemia, and lymphoma 13. Known history of Reynaud's Disease compromised liver function, cold agglutination, cold sensitivity, cryoglobulinemia, cryofibrinogenemia, and/or a history of severe migraines 14. Known or disclosed pregnancy or breast-feeding 15. Sustains another head or neck injury at the time of concussive injury which requires medical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change quantified by post-concussion symptom severity (PCSS) assessment score | Post-injury to 72-hour follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events associated with the head-and-neck cooling treatment | Treatment to 72-hour follow-up |
Countries
United States
Contacts
CONTACTJohn Zak, MD, MBA
CONTACTRebecca Zickert
PRINCIPAL_INVESTIGATORBrian Reilly, MD
Children's Hospital Medical Center of Akron
Outcome results
None listed