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

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.

Study Overview

• Status: Recruiting
• Conditions: Concussion, Mild
• Intervention / Treatment: Device: Pro2Cool Device; Device: Sham Cooling Garment Device

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Zak, MD, MBA; Phone Number: 216-789-7676; Email: jzak@tectraum.com
• Study Contact Backup: Name: Rebecca Zickert; Email: rebecca.zickert@brightresearch.com

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Not yet recruiting
      • University of Michigan
      • Principal Investigator: Ingrid Ichesco, MD
  • Ohio
    • Akron, Ohio, United States, 44308
      • Recruiting
      • Akron Children's Hospital
      • Principal Investigator: Brian Reilly, MD
    • Cleveland, Ohio, United States, 44125
      • Not yet recruiting
      • Cleveland Clinic Foundation
      • Principal Investigator: Sami Rifat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pro2Cool intervention with standard of care; The treatment arm will receive standard of care for concussion along with 30 minutes of headneck cooling in the clinic while being monitored for side effects. The Pro2Cool® will be used to provide head and neck cooling.	Device: Pro2Cool 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.
Sham Comparator: Sham Pro2Cool with standard of care; The control arm will receive standard of care like the treatment group, along with 30 minutes of sham Pro2Cool® placement in the clinic while being monitored for side effects. The Pro2Cool® device will not be used to provide neck cooling; a 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).	Device: Sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change quantified by post-concussion symptom severity (PCSS) assessment score	Post-injury to 72-hour follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events associated with the head-and-neck cooling treatment	Treatment to 72-hour follow-up

Collaborators and Investigators

• Sponsor: TecTraum Inc.
• Investigators: Principal Investigator: Brian Reilly, MD, Children's Hospital Medical Center of Akron

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Non-invasive hypothermic therapy; Sports-related concussion
• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Concussion
• Other Study ID Numbers: 1380718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes