Clinical trial NCT06929923: Pro-2-Cool Pivotal Trial II
Official title: An Assessment of Clinical Efficacy of Hypothermic Therapy Following Mild Traumatic Brain Injury (mTBI) in the Adolescent Athlete as Compared to an Untreated Active Control Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: Non-invasive hypothermic therapy
Lead sponsor: TecTraum Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 72
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: SCAT-5 change from baseline to the post-72 hour follow-up visit measurement
timeFrame: Baseline to 72-hour follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center of Akron
name: Brian Reilly, MD
role: PRINCIPAL_INVESTIGATOR
References: