Pro-2-Cool Pivotal Trial II

TecTraum

Status: Suspended

Conditions: Mild Traumatic Brain Injury

Treatments: Device: Pro-2-Cool Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT06929923

1380718

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Pro-2-Cool Device

Experimental group

Treatment:

Device: Pro-2-Cool Device

Standard of Care

No Intervention group

Description:

"Brain rest"