Clinical trial NCT03511339: Pro-2-Cool Device Clinical Study
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: Concussion
TBI
mTBI
Lead sponsor: TecTraum Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bright Research Partners
name: Akron Children's Hospital
First posted: 2018-04-27
Enrollment: 174
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Change from initial visit to 4 weeks
Secondary outcomes:
measure: Recovery time from initial visit, summarized by group and compared in the treatment group to control.
timeFrame: Initial visit through earliest follow up where complete recovery is observed, maximum of 4 weeks after initial visit.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan - Michigan Medicine
state: Michigan
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Boardman
country: United States
facility: Akron Children's Hospital, Mahoning Valley Campus
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Children's Hospital
state: Ohio
Study officials:
affiliation: Akron Children's Hospital
name: Joseph Congeni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Congeni J, Murray T, Kline P, Bouhenni R, Morgan D, Liebig C, Lesak A, McNinch NL. Preliminary Safety and Efficacy of Head and Neck Cooling Therapy After Concussion in Adolescent Athletes: A Randomized Pilot Trial. Clin J Sport Med. 2022 Jul 1;32(4):341-347. doi: 10.1097/JSM.0000000000000916. Epub 2021 Mar 10.