Pro-2-Cool Device for Concussion

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a head and neck cooling device called the Pro-2-Cool to evaluate its effectiveness in aiding recovery from concussions (mild traumatic brain injuries) in young athletes. The study aims to assess the device's safety and effectiveness compared to regular "brain rest" after an injury. Teenagers and young adults aged 12-21, who recently sustained a concussion from sports and are experiencing symptoms, might be suitable candidates for this trial. Participants should not have severe injuries or serious medical conditions. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance concussion recovery methods.

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 prior data suggests that the Pro-2-Cool device is safe for adolescents with mTBI?

Research has shown that the Pro-2-Cool device, which cools the head and neck, may help treat concussions. Studies have found that most people can use the device without major side effects. In one study, participants used it for up to 30 minutes, and no serious problems were reported.

The device has been tested at various times after a concussion, and no severe safety issues have emerged. Although still under study and not yet approved for general use, early results suggest it could be a safe way to manage concussion symptoms. This is promising for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Pro-2-Cool Device is unique because it provides a new approach to managing concussions by using therapeutic cooling technology. Unlike the standard practice of "brain rest," which involves limiting physical and cognitive activities, this device aims to cool the brain, potentially reducing inflammation and speeding up recovery. Researchers are excited because this method could offer a more active treatment option, potentially leading to quicker and more effective recovery times for concussion patients.

What evidence suggests that the Pro-2-Cool device is effective for concussion?

Research has shown that the Pro-2-Cool device, which cools the head and neck, helps reduce concussion symptoms in teenagers. In this trial, participants may receive the Pro-2-Cool device as an experimental treatment. Studies have found that using this device within eight days after a mild traumatic brain injury (mTBI) can significantly speed up recovery, easing symptoms like headaches and dizziness. The cooling method is safe and has shown promising results in young athletes. Overall, the device is becoming recognized as a helpful tool for managing concussions. ^{2 3 4 5 6}

Who Is on the Research Team?

Brian Reilly, MD

Principal Investigator

Children's Hospital Medical Center of Akron

Are You a Good Fit for This Trial?

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

I saw a doctor within 8 days of my mild brain injury.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. akronchildrens.org akronchildrens.org/clinical-studies/Pro-2-Cool-concussion-study.html

Pro-2-Cool Study The purpose of this research is to find out whether the Pro-2-Cool cooling cap helps treat concussions when added to the current brain rest treatment. Study ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03511339?term=AREA%5BConditionSearch%5D(Cool)%20AND%20AREA%5BLastUpdatePostDate%5D%20RANGE%5B2020-02-09,MAX%5D&rank=8

NCT03511339 | Pro-2-Cool Device Clinical Study This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling when applied up to 8 days after mild traumatic brain injury ...

3. pro2coolrx.com pro2coolrx.com/

Pro-2-Cool | Advanced Concussion Therapy Researchers investigating the pro2cool™ device have observed significant improvements in clinical outcomes through the cooling of the brain within eight days of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11042520/

Reduced Concussion Symptom Burden in Early ... This study demonstrates the efficacy and safety of head and neck cooling for the management of concussion symptoms in adolescent athletes.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06929923

Study Details | NCT06929923 | Pro-2-Cool Pivotal Trial II 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 ...

6. journals.lww.com journals.lww.com/cjsportsmed/fulltext/2022/07000/preliminary_safety_and_efficacy_of_head_and_neck.2.aspx

Preliminary Safety and Efficacy of Head and Neck Cooling... Treatment with the Pro-2cool device (Figure 2) was performed for a maximum of 30 minutes for the study participants in the treatment group at the post-injury ...