- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03511339
Pro-2-Cool Device Clinical Study
Pro-2-Cool Device Clinical Study: an Assessment of Clinical Efficacy of Hypothermic Therapy Following Mild Traumatic Brain Injury (mTBI) in the Adolescent Athlete as Compared to an Untreated Active Control Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48108
- University of Michigan - Michigan Medicine
-
-
Ohio
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Akron, Ohio, United States, 44308-1062
- Akron Children's Hospital
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Boardman, Ohio, United States, 44512
- Akron Children's Hospital, Mahoning Valley Campus
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Dayton, Ohio, United States, 45404
- Dayton Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Brain rest
|
|
Experimental: TecTraum Device
Treatment with study device
|
A non-invasive hypothermic therapy ("cold therapy") TecTraum device that provides localized cooling of the head and neck.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The SCAT5 overall score will be collected at the initial visit in the Sports Medicine Clinic, and compared to follow-up visits throughout the study, with the objective of demonstrating better outcomes in the treatment group compared to the control group.
Time Frame: Change from initial visit to 4 weeks
|
Formal statistical hypothesis testing will be employed in the evaluation of this endpoint. Additionally, comparisons between treatment groups on the baseline SCAT5 (SCAT5-PRE) will be performed at initial visit (as reported by subject) and at each follow-up (72 hours, 10 days, and 4 weeks) separately to evaluate the time trend in recovery. Individual SCAT5 symptoms, each scored on a scale of 0-6, will also be summarized and compared by treatment group to investigate the effect of treatment on specific symptoms. These comparisons are intended to provide additional information on the pattern of recovery and are not attached to intended labeling claims; however, statistical testing of these endpoints will be accompanied by adjustment for multiplicity using the Hochberg-Holm method. |
Change from initial visit to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovery time from initial visit, summarized by group and compared in the treatment group to control.
Time Frame: Initial visit through earliest follow up where complete recovery is observed, maximum of 4 weeks after initial visit.
|
Recovery time from initial visit will be formally evaluated for differences between treatment and control.
|
Initial visit through earliest follow up where complete recovery is observed, maximum of 4 weeks after initial visit.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1289670
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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