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TecTraum device for Concussion

N/A
Waitlist Available
Led By Joseph Congeni, MD
Research Sponsored by TecTraum Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from initial visit to 4 weeks
Awards & highlights

Study Summary

This trial is testing how well cooling the head and neck region (up to 8 days after mTBI) works in adolescents who participate in sports.

Eligible Conditions
  • Concussion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from initial visit to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from initial visit to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Recovery time from initial visit, summarized by group and compared in the treatment group to control.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TecTraum DeviceExperimental Treatment1 Intervention
Treatment with study device
Group II: ControlActive Control1 Intervention
Brain rest
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TecTraum device
2017
N/A
~180

Find a Location

Who is running the clinical trial?

Akron Children's HospitalOTHER
48 Previous Clinical Trials
5,008,420 Total Patients Enrolled
Bright Research PartnersIndustry Sponsor
13 Previous Clinical Trials
1,580 Total Patients Enrolled
TecTraum Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Clinical Journal of Sport MedicineJournal
Preliminary Safety and Efficacy of Head and Neck Cooling Therapy After Concussion in Adolescent Athletes: A Randomized Pilot Trial
Congeni, Joseph, Tamara Murray, Peyton Kline, Rachida Bouhenni, Danielle Morgan, Christopher Liebig, Alexandria Lesak, and Neil L. McNinch. 2021. “Preliminary Safety and Efficacy of Head and Neck Cooling Therapy After Concussion in Adolescent Athletes: A Randomized Pilot Trial”. Clinical Journal of Sport Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/jsm.0000000000000916.
Clinical Journal of Sport MedicineJournal
Preliminary Safety and Efficacy of Head and Neck Cooling Therapy After Concussion in Adolescent Athletes: A Randomized Pilot Trial
Congeni, Joseph, Tamara Murray, Peyton Kline, Rachida Bouhenni, Danielle Morgan, Christopher Liebig, Alexandria Lesak, and Neil L. McNinch. 2021. “Preliminary Safety and Efficacy of Head and Neck Cooling Therapy After Concussion in Adolescent Athletes: A Randomized Pilot Trial”. Clinical Journal of Sport Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/jsm.0000000000000916.
clinicaltrials.govStudy
Pro-2-Cool Device Clinical Study
2017. "Pro-2-Cool Device Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03511339.
~23 spots leftby Apr 2025
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