Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups

Brain Injuries, Traumatic Clinical Trial

Official title:

The Use of a Portable 3D Head Mounted Display With Integrated Eye Capture Technology (I-PAS) for the Objectification and Quantification of Signs and Symptoms Associated With the Diagnosis of Mild Traumatic Brain Injury (mTBI)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03515967
• Other study ID #: 20170209
• Status: Withdrawn
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: April 8, 2019

Study information

• Verified date: June 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study will test the use of a short virtual reality driven goggle test as a means of detecting mTBI in a diverse group of athletes

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Participants from 18 - 90 years of age who participate in all amateur athletics at the University of Miami to include all levels of sports whether National Collegiate Athletic Association (NCAA) or Club. Initial recruitment will include high intensity sports, including but not limited to Men's football, Men's and Women's Soccer, Men's and Women's Basketball, Men's and Women's Volleyball, Men's Baseball and Women's Softball, and Club sports to include Men's and Women's Lacrosse, Hockey, Rugby, and Field Hockey).

2. Participants from 18-90 years of age who are or have been engaged in Olympic level competitions as an active participant or team member.

3. Participants from 18-90 years of age who are engaged in professional sports as an active participant or formerly as a team member. Initial recruitment will include all motor sports, ice and field hockey, football, soccer, basketball, and rugby.

Exclusion Criteria:

1. History of brain injury resulting from a penetrating wound to the head.

2. Presence of aphasia and/or inability to give informed consent for participation

3. History of diagnosed neuropsychiatric disorders

4. Documented neurodegenerative disorders

5. 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

6. Cerebrovascular disorders

7. History of ear operation other than myringotomy tube in the past

8. Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc.

9. Presence of intra-cranial structural findings on imaging studies

10. Prisoners

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

Device:
• I-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	Neuro Kinetics, Syneos Health

References & Publications (2)

Balaban C, Hoffer ME, Szczupak M, Snapp H, Crawford J, Murphy S, Marshall K, Pelusso C, Knowles S, Kiderman A. Oculomotor, Vestibular, and Reaction Time Tests in Mild Traumatic Brain Injury. PLoS One. 2016 Sep 21;11(9):e0162168. doi: 10.1371/journal.pone.0162168. eCollection 2016. — View Citation

Hoffer ME, Balaban C, Szczupak M, Buskirk J, Snapp H, Crawford J, Wise S, Murphy S, Marshall K, Pelusso C, Knowles S, Kiderman A. The use of oculomotor, vestibular, and reaction time tests to assess mild traumatic brain injury (mTBI) over time. Laryngoscope Investig Otolaryngol. 2017 Apr 12;2(4):157-165. doi: 10.1002/lio2.74. eCollection 2017 Aug. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with mTBI	How many participants were detected to have mTBI following a sports-related injury	45 months
Secondary	Time to recover	Measuring the time (days) it takes for readiness to return to sports activity after sports-related injury for participants with a detected mTBI	45 months