Innovative Concussion Prevention Device

NCT02901028 | Completed DMC

• 1 other identifier: 2013-2240
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Measure any changes in blood physiologies

  To monitor changes blood physiologies in a population of athletes wearing the Device.

  1 week

• measure any changes in oxygen consumption

  To monitor changes oxygen consumption in a population of athletes wearing the Device.

  1 week

• measure any changes in strength

  To monitor changes in strength in a population of athletes wearing the Device.

  1 week

• Measure any changes in biomechanics

  To monitor changes in biomechanics balance in a population of athletes wearing the Device.

  1 week

• Measure any changes in neurological capabilities

  To monitor changes in neurological capabilities in a population of athletes wearing the Device.

  1 week

• Measure any changes in balance

  To monitor changes in and balance in a population of athletes wearing the Device.

  1 week

Secondary Outcomes (1)

• Number of participants with intervention-related adverse events as assessed by participant survey

  1 week

Study Arms (2)

Collar Device

EXPERIMENTAL

The Device is a standard hockey neck guard, adapted for the purposes of this study. The Device incorporates two bulges localized over the site of the internal jugular veins bilaterally. Experiments performed with jugular Doppler ultrasound demonstrate that while wearing the Device, flows within the jugular veins are reduced, while flow within the carotid arteries and all portions of the cerebrum are preserved (JA Fisher, unpublished data). Thus, application of the Device to the subject will not cause any untoward health risks. The pressure exerted by the Device on the region of the neck superficial to the internal jugular vein is akin to the pressure felt when a person yawns or wears a snugly fitting necktie.

Other: Laboratory testing; Other: Blood and Urine Draws

Arm Device

SHAM COMPARATOR

the subject is wearing a sham arm device, which will be placed on the upper arm and not cause venous engorgement. The subject will undergo the same testing as when wearing the collar device (strength, Vo2, vision, blood, urine, etc)

Other: Laboratory testing; Other: Blood and Urine Draws

Interventions

Laboratory testing OTHER

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

Arm Device; Collar Device

Blood and Urine Draws OTHER

subjects will have a blood draw and provide a urine sample

Arm Device; Collar Device

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal healthy volunteer
• Able to provide written consent
• Able to tolerate hypercapnia for 1-2 minutes
• Must be 18 years or older

You may not qualify if:

• Unable to provide written consent
• History of neurological deficits, previous cerebral infarction, or head trauma
• Medical contraindications to limited hypercapnia or restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
• Glaucoma (Narrow Angle or Normal Tension)
• Hydrocephalus
• Recent penetrating brain trauma (within 6 months)
• Known carotid hypersensitivity
• Known increased intracranial pressure
• Central vein thrombosis
• Known open eye injuries
• Neck injuries
• Any known airway obstruction
• Any known seizure disorder
• Any altered level of consciousness
• Have suffered an injury to a lower extremity in the past 6 months

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gregory D Myer, PhD

  Cincinnati Childrens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: September 15, 2016
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)