Pro-2-Cool Pivotal Trial II

ConditionConcussion, Mild

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age13-21

SponsorTecTraum Inc.

About this trial

This study is being conducted to determine the clinical safety and efficacy of Pro-2-Cool mediated head and neck cooling when applied after concussion and improved symptomatology among adolescent athletes as quantified by post-concussion symptom severity (PCSS) score.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females, 13-21 years of age

Glasgow Coma Scale (GCS) score of less than 13 at 30 minutes post-injury

Loss of consciousness greater than 30 minutes

Post-traumatic amnesia lasting over 24 hours

Disqualifiers

Age < 13 years or > 21 years

Inability to understand the study requirements or provide informed consent

Cleared to return to play during initial visit

Prior participation in a Pro2Cool Clinical Study

Trial design

Design model

Parallel

Treatments tested in this trial

Pro2Cool Device
Device
The Pro2Cool 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.
Sham Cooling Garment Device
Device
The sham cooling garment device will be placed with impaired cooling function (only to the head), with sham treatment temperature being set to 19°C (instead of the therapeutic 6°C specification). There will be no thermal nylon barrier that will be used and flow to the neck bladder will be closed.

Treatment groups

66 Participants

are divided into 2 treatment groups

Group A: Pro2Cool intervention with standard of careExperimental treatment 1 intervention

Group B: Sham Pro2Cool with standard of careSham comparator 1 intervention

Trial outcomes

Primary outcomes

Change quantified by post-concussion symptom severity (PCSS) assessment score

Time frame

Post-injury to 72-hour follow-up

Secondary outcomes

Number of adverse events associated with the head-and-neck cooling treatment

Time frame

Treatment to 72-hour follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TecTraum Inc.

Lead sponsor

Source ClinicalTrials.gov

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