Pro-2-Cool Device Clinical Study

TecTraum

Status

Completed

Conditions

Mild Traumatic Brain Injury

Treatments

Device: TecTraum device

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03511339

1289670

Details and patient eligibility

About

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.

Full description

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.

Enrollment

174 patients

Sex

All

Ages

12 to 21 years old

Volunteers

No Healthy Volunteers

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