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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.
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
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Inclusion criteria
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:
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
Primary purpose
Allocation
Interventional model
Masking
174 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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