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Testing mTBI in Athletes

NCT ID: NCT02486003

Last Updated: 2017-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

329 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-08-14

Brief Summary

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This study will assess the effectiveness of a portable goggle system in the diagnosis of mild traumatic brain injury (mTBI) in athletes.

Detailed Description

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The purpose of this research study is to assess oculomotor, vestibular and reaction time responses in mild traumatic brain injury (mTBI) athletes, as well as healthy individuals. These measurements will be recorded using a portable goggle system (IPAS). The goal is to determine whether this IPAS goggle system is effective at diagnosing mTBI. A secondary goal is to determine whether this IPAS goggle system is effective at ruling out the diagnosis of mTBI in athletes and non-athletes that do not have the condition.

The IPAS is a portable 3D head mounted display. The IPAS goggles are programmed with a series of tests that track eye motions in response to a target. This device has been determined to be a Non-Significant Risk to study participants.

There are three groups of interest in this study: athletes who suffer an mTBI, athletes who do have an mTBI, and healthy non-athletes.

Conditions

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Mild Traumatic Brain Injury Brain Concussion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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mTBI athletes

College athletes who undergo an mTBI during the season

No interventions assigned to this group

Control athletes

College athletes who do not undergo an mTBI during the season

No interventions assigned to this group

Control non-athletes

Control non-athletes with long term follow-up of approximately 4-6 weeks and 3-5 months

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Males and females from 18 - 40 years of age who participate in intercollegiate athletics at the University of Miami to include all levels of sports whether NCAA or club. Initial recruitment will include high intensity sports alone (these include but are not limited to football, Men's and Women's Soccer, Men's and Women's Basketball, Men's Baseball and Women's Softball, and club sports to include Men's and Women's Lacrosse, Hockey, Rugby, and Field Hockey).

Exclusion Criteria

* History of brain injury resulting from a penetrating wound to the head.
* Presence of severe aphasia
* History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia
* Documented neurodegenerative disorders
* Pregnancy, \[Female candidates will be asked if they are pregnant\]
* Prior disorders of hearing and balance including:

1. Meniere's disease
2. Multiple sclerosis
3. Vestibular neuritis
4. Vestibular schwannoma
5. Sudden sensorineural hearing loss
* Cerebrovascular disorders
* History of ear operation other than myringotomy tube in the past
* Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Football League

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Michael E. Hoffer

Professor of Otolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20150361

Identifier Type: -

Identifier Source: org_study_id