Pro-2-Cool Device for Concussion

Recruiting at 1 trial location

Overseen By John Zak, MD, MBA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: TecTraum Inc.

Disqualifiers: Serious TBI, Psychiatric disorder, Cerebrovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 72

Duration: 72 hours

72 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling, using the Pro-2-Cool device, when applied after mTBI injury sustained by adolescents aged 12-21 years, participating in sporting activities.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What data supports the effectiveness of the Pro-2-Cool Device treatment for concussion?

Research shows that cooling the head and neck can help reduce brain temperature and pressure, which may be beneficial after a concussion. A study on adolescent athletes found that head and neck cooling was safe and potentially effective when used after a concussion. ^{1 2 3 4 5}

Is the Pro-2-Cool Device safe for use in humans?

Head and neck cooling, similar to the Pro-2-Cool Device, has been studied for safety. In a study with adolescent athletes, head and neck cooling was evaluated for safety after concussions. Another study on a similar cooling device in animals found it was well tolerated without significant adverse effects. ^{1 5 6 7 8}

How does the Pro-2-Cool Device treatment for concussion differ from other treatments?

The Pro-2-Cool Device is unique because it uses head and neck cooling to treat concussions, which is different from other treatments that may not focus on temperature regulation. This cooling method is designed to be applied up to 8 days after a concussion, offering a novel approach to managing symptoms by potentially reducing brain temperature and inflammation. ^{1 4 5 9 10}

Research Team

Brian Reilly, MD

Principal Investigator

Children's Hospital Medical Center of Akron

Eligibility Criteria

The Pro-2-Cool Pivotal Trial II is for adolescents aged 12-21 who have suffered a mild traumatic brain injury (mTBI), such as a concussion, while participating in sports. Specific eligibility criteria are not provided.

Inclusion Criteria

In generally good health as confirmed by medical history and as determined by site investigator

Has informed consent obtained per protocol and as required per IRB

My symptom score is 7 or higher.

Exclusion Criteria

Cleared to return to play during initial visit

Currently enrolled in another investigational research study that may confound the results of this study

Non-English speaking subjects and parents/legal guardians

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive head and neck cooling using the Pro-2-Cool device after mTBI

72 hours

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 hours

Post-72 hour follow-up visit

Treatment Details

Interventions

• Pro-2-Cool Device

Trial Overview This trial tests the safety and effectiveness of the Pro-2-Cool device, which cools the head and neck area after an adolescent has sustained an mTBI during sports activities.

Participant Groups

Group I: Pro-2-Cool Device Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

"Brain rest"

Who Is Running the Clinical Trial?

TecTraum Inc.

Lead Sponsor

Trials

1

Recruited

170+

Findings from Research

A 27-year-old professional rugby player with a history of 20 concussions showed significant improvement in post-concussion syndrome after 30 sessions of cervical rehabilitation, with lasting benefits observed over 6 years.

Post-treatment, the player's cervical spinal alignment improved significantly, and he experienced only two additional concussions in the following six years, suggesting that correcting cervical alignment may help reduce the risk of future concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-concussion syndrome and concussion incidence improved in a pro rugby player following cervical spine rehab: case study and 6-year follow-up. Strauss, S., Lightstone, DF., Fedorchuk, C., et al.[2023]

A pilot study involving seven patients in a neurocritical care unit demonstrated that a novel transnasal high flow air device effectively reduced core body temperature in febrile patients, with significant cooling observed after just 2 hours.

The method was safe, with no adverse events or shivering reported, suggesting it could be a promising non-pharmacologic option for managing fever in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transnasal High Flow Air to Reduce Core Body Temperature in Febrile Neurocritical Care Patients: A Pilot Study. Ziai, WC., Shah, D., Assis, FR., et al.[2022]

The CoolStat™ device effectively induced and maintained hypothermia in Yorkshire pigs, achieving the target brain temperature within 0.5 hours and maintaining it with high precision (99.9% of the time within ±0.5°C) during an 8-hour treatment period.

Safety assessments showed that both maximum air flow and prolonged therapy (24 hours) were well tolerated, with no significant damage to the nasal mucosa observed, indicating the device's potential for safe use in an ambulatory setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Transnasal CoolStat Cooling Device to Induce and Maintain Hypothermia. Assis, FR., Bigelow, MEG., Chava, R., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preliminary Safety and Efficacy of Head and Neck Cooling Therapy After Concussion in Adolescent Athletes: A Randomized Pilot Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Post-concussion syndrome and concussion incidence improved in a pro rugby player following cervical spine rehab: case study and 6-year follow-up. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Regional cooling for reducing brain temperature and intracranial pressure. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transnasal High Flow Air to Reduce Core Body Temperature in Febrile Neurocritical Care Patients: A Pilot Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Hemodynamic and thermal responses to head and neck cooling in men and women. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Transnasal CoolStat Cooling Device to Induce and Maintain Hypothermia. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Head and neck cooling decreases tympanic and skin temperature, but significantly increases blood pressure. [2016]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Concussion clinic referral demographics and recommendations: a retrospective analysis. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

A six degree of freedom head acceleration measurement device for use in football. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Portable video-oculography device for implementation in sideline concussion assessments: a prototype. [2020]