Pro-2-Cool Pivotal Trial II

NCT ID: NCT06929923

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2026-02-28

Brief Summary

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.

Detailed Description

This is a multi-center, prospective, randomized, non-blinded, dual-arm comparator study enrolling up to a total of 72 patients (approximately 36 patients in the treatment arm and 36 patients in the control arm) following sports-related, mTBI.

Conditions

Mild Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pro-2-Cool Device

Group Type: EXPERIMENTAL

Pro-2-Cool Device

Intervention Type: DEVICE

The Pro-2-Cool 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.

Standard of Care

"Brain rest"

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pro-2-Cool Device

The Pro-2-Cool 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Males and females ages 12 - 21 years

2. Initial provider visit is within 8 days of mTBI injury

3. Confirmed mTBI diagnosis from sporting activities

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

5. Has a symptom score of at least 7 (analogous of the SCAT5 symptoms score)

6. Has informed consent obtained per protocol and as required per IRB

Exclusion Criteria

1. Cleared to return to play during initial visit

2. Suffers a serious TBI as evidenced by worsening symptoms, specifically:

2.1. GCS <14 2.2. Seizure 2.3. Hospitalization 2.4. Existing positive diagnostic testing which include radiology scans that indicate brain bleed 2.5. Slurred speech, which has not resolved within 72 hours of mTBI injury

3. Sustains another head or neck injury at the time of mTBI injury which requires medical treatment

4. History of a serious medical or psychiatric disorder that include:

4.1. Suicide attempt in the last 6 months 4.2. Unmanaged depression or anxiety 4.3. Hospitalization in the last 6 months for psychiatric treatment

5. History of Reynaud's disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia

6. Previously diagnosed with a cerebrovascular disorder

7. Is unable to understand the study requirements or the informed consent

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

9. Non-English speaking subjects and parents/legal guardians

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TecTraum Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Reilly, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center of Akron

Locations

University of Michigan

Ann Arbor, Michigan, United States

Akron Children's Hospital

Akron, Ohio, United States

Countries

United States

Other Identifiers

1380718

Identifier Type: -

Identifier Source: org_study_id