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
1 other identifier
interventional
66
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2025
CompletedFirst Submitted
Initial submission to the registry
April 14, 2025
CompletedFirst Posted
Study publicly available on registry
April 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
June 11, 2026
June 1, 2026
2.3 years
April 14, 2025
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change quantified by post-concussion symptom severity (PCSS) assessment score
Post-injury to 72-hour follow-up
Secondary Outcomes (1)
Number of adverse events associated with the head-and-neck cooling treatment
Treatment to 72-hour follow-up
Study Arms (2)
Pro2Cool intervention with standard of care
EXPERIMENTALThe 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.
Sham Pro2Cool with standard of care
SHAM COMPARATORThe 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- Males and females, 13-21 years of age
- 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
- Glasgow Coma Scale (GCS) ≥ 13 at the time of initial injury for study enrollment.
- Post-Concussion Symptom Scale Score minimum of 15
- Initial provider visit is within 7 days of injury
- 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.
- Has informed consent obtained per protocol and as required per Institutional Review Board
You may not qualify if:
- Age \< 13 years or \> 21 years
- Inability to understand the study requirements or provide informed consent
- Cleared to return to play during initial visit
- Prior participation in a Pro2Cool Clinical Study
- 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
- Physical (e.g., head or neck injury that requires medical treatment) or mental disability hindering adequate response to assessment of symptoms
- Hemodynamic instability/medical condition requiring further acute life-saving medical intervention
- 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
- Known brain mass, intracranial hemorrhage, skull fracture
- Scalp abnormalities including laceration or bleeding
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TecTraum Inc.lead
Study Sites (3)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44125, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Reilly, MD
Children's Hospital Medical Center of Akron
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2025
First Posted
April 16, 2025
Study Start
February 20, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
June 11, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share