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Innovative Concussion Prevention Device

NCT02901028 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-09-15

No results posted yet for this study

Summary

Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge costs currently being experienced for life-treatment of surviving victims. An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver. PURPOSE: To monitor changes in vital signs, blood physiologies, oxygen consumption, biomechanics, strength, neurological capabilities, and balance in a population of athletes wearing the Device. Secondly, to determine the tolerance and acceptance of the Device while undergoing exertion.

Conditions

  • Concussion

Interventions

OTHER

Laboratory testing

Subjects will visit the Human Performance Laboratory on two separate occasions to perform the testing procedures. testing consists of VO2, strength, biomechanics, dynavision, etc.

OTHER

Blood and Urine Draws

subjects will have a blood draw and provide a urine sample

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Gregory D Myer, PhD · Cincinnati Childrens Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-07-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02901028 on ClinicalTrials.gov