Pro-2-Cool Device Clinical Study
1 other identifier
interventional
174
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2017
CompletedFirst Submitted
Initial submission to the registry
March 30, 2018
CompletedFirst Posted
Study publicly available on registry
April 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2022
CompletedMay 3, 2023
May 1, 2023
4.5 years
March 30, 2018
May 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (1)
Recovery time from initial visit, summarized by group and compared in the treatment group to control.
Initial visit through earliest follow up where complete recovery is observed, maximum of 4 weeks after initial visit.
Study Arms (2)
Control
NO INTERVENTIONBrain rest
TecTraum Device
EXPERIMENTALTreatment with study device
Interventions
A non-invasive hypothermic therapy ("cold therapy") TecTraum device that provides localized cooling of the head and neck.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TecTraum Inc.lead
- Bright Research Partnerscollaborator
- Akron Children's Hospitalcollaborator
Study Sites (5)
University of Michigan - Michigan Medicine
Ann Arbor, Michigan, 48108, United States
Akron Children's Hospital
Akron, Ohio, 44308-1062, United States
Akron Children's Hospital, Mahoning Valley Campus
Boardman, Ohio, 44512, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Dayton Children's Hospital
Dayton, Ohio, 45404, United States
Related Publications (1)
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.
PMID: 34009790RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Congeni, MD
Akron Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2018
First Posted
April 27, 2018
Study Start
November 4, 2017
Primary Completion
April 27, 2022
Study Completion
May 29, 2022
Last Updated
May 3, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share