Pro-2-Cool Device Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-04

Study Completion Date

2022-05-29

Brief Summary

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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.

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Detailed Description

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This is a single-center, prospective, randomized, non-blinded, dual-arm comparator study that will include two-phases, the 60-patient pilot study (30 patients in the treatment arm and 30 patients in the control arm) followed by a pivotal study (up to 200 patients in the treatment and control arm combined) for a total of up to 260 patients overall in both phases. The pilot study will serve as an opportunity to assess the protocol and make adjustments, if necessary. In addition, descriptive statistics including effect size will be calculated and the safety of the device will be assessed at the conclusion of the pilot study.

Subjects will be assigned to study arm based on a block randomization schedule generated a priori.

The study sponsor believes that the device and therapeutic treatment that will be evaluated in this study is a non-significant risk (NSR) to the subjects.

Conditions

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Mild Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Brain rest

Group Type NO_INTERVENTION

No interventions assigned to this group

TecTraum Device

Treatment with study device

Group Type EXPERIMENTAL

TecTraum device

Intervention Type DEVICE

A non-invasive hypothermic therapy ("cold therapy") TecTraum device that provides localized cooling of the head and neck.

Interventions

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TecTraum device

A non-invasive hypothermic therapy ("cold therapy") TecTraum device that provides localized cooling of the head and neck.

Intervention Type DEVICE

Other Intervention Names

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Pro-2-Cool

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No