Testing mTBI in Athletes

NCT02486003 | Completed

• 1 other identifier: 20150361
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild Traumatic Brain Injury; Brain Concussion

Outcome Measures

Primary Outcomes (1)

• Vestibular, oculomotor, and reaction time test results

  IPAS testing will be conducted by placing the IPAS goggles on the head of a patient and asking the patient to follow instructions while a set of tests is performed. Each of these tests simply involves eye motions in response to a target.

  3 months

Study Arms (3)

mTBI athletes

College athletes who undergo an mTBI during the season

Control athletes

College athletes who do not undergo an mTBI during the season

Control non-athletes

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the population of athletes in the intercollege athletic programs at the University of Miami. This will include athletes in NCAA Sports as well as intercollege club sports. Aged and sex matched controls will be collected from the general student body of the University of Miami.

You may qualify if:

• 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).

You may not qualify if:

• 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:
• Meniere's disease
• Multiple sclerosis
• Vestibular neuritis
• Vestibular schwannoma
• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Football League: collaborator

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Brain Concussion

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: June 30, 2015
• Study Start: May 1, 2015
• Primary Completion: August 14, 2017
• Study Completion: August 14, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Locations

US (1)