Pro-2-Cool Device Clinical Study

Completed · Not applicable

Conditions studied: Mild Traumatic Brain Injury

In brief

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 (mTBI) among adolescents participating in sporting activities.

Key facts

Study ID

NCT03511339

Run by

TecTraum Inc.

People needed

174

Starts

2017-11-04

Expected to finish

2022-05-29

Last updated by the study team

2023-05-03

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females ages 12 - 21 years
• Initial provider visit is within 8 days of mTBI injury
• Confirmed mTBI diagnosis from sporting activities
• In generally good health as confirmed by medical history and as determined by site investigator
• Has a symptom score of at least 7 (analogous of the SCAT5 symptoms score)
• Has informed consent obtained per protocol and as required per Institutional Review Board (IRB)

You may not qualify if…

• Cleared to return to play during initial visit
• Suffers a serious TBI as evidenced by worsening symptoms, specifically:
• Seizure
• Hospitalization
• Existing positive diagnostic testing, which include radiology scans that indicate brain bleed
• Slurred speech, which has not resolved within 72 hours of mTBI injury
• Sustains another head or neck injury at the time of mTBI injury which requires medical treatment
• Known or disclosed pregnancy or breast-feeding
• History of a serious medical or psychiatric disorder that include:
• Suicide attempt in the last 6 months
• Unmanaged depression or anxiety
• Hospitalization in the last 6 months for psychiatric treatment
• History of Reynaud's disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
• Previously diagnosed with a cerebrovascular disorder
• Is unable to understand the study requirements or the informed consent
• Currently enrolled in another investigational research study that may confound the results of this study
• Non-English speaking subjects and parents/legal guardians

Where it is running

• University of Michigan - Michigan Medicine — Ann Arbor, Michigan, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Akron Children's Hospital, Mahoning Valley Campus — Boardman, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Dayton Children's Hospital — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.