BridgeMD
New treatment option for Concussion, Mild
Official title Pro-2-Cool Pivotal Trial II
ClinicalTrials.gov ID: NCT06929923
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 21
You may be able to join 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
You likely can't join if
- Age \ 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
See the full eligibility criteria
- 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
- Age \ 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
- Presence of ventriculoperitoneal (VP) shunt
- Known hematological malignancies, including, but not limited to: multiple myeloma, leukemia, and lymphoma
- Known history of Reynaud's Disease compromised liver function, cold agglutination, cold sensitivity, cryoglobulinemia, cryofibrinogenemia, and/or a history of severe migraines
- Known or disclosed pregnancy or breast-feeding
- Sustains another head or neck injury at the time of concussive injury which requires medical treatment
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- Akron, Ohio, United States
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; Akron, Ohio, United States; Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.