Brain Injuries, TraumaticNCT03515967
Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups
A study testing I-PAS Goggles in people with Brain Injuries, Traumatic, run by University of Miami.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- I-PAS Goggles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Mar 2018to 8 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- Participants from 18-90 years of age who are or have been engaged in Olympic level competitions as an active participant or team member.
- 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.
Who cannot join
- History of brain injury resulting from a penetrating wound to the head.
- Presence of aphasia and/or inability to give informed consent for participation
- History of diagnosed neuropsychiatric disorders
- Documented neurodegenerative disorders
- Prior disorders of hearing and balance including:
- Meniere's disease
Show all 15Show fewer
- 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.
- Presence of intra-cranial structural findings on imaging studies
- Prisoners
About this study
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)
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
- Conditions
- Brain Injuries, Traumatic
- Being tested
- I-PAS Goggles
- Keywords
- concussion, mild traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-PAS GogglesDevice
Portable, head-mounted display goggle system with integrated eye capture technology
| Study group | Role | What they receive |
|---|---|---|
| Injured Athletes | Experimental | Athletes tested for mild traumatic brain injury (mTBI) after injury using the I-PAS goggles Receives: Device: I-PAS Goggles |
| Non-Injured Athletes | Active comparator | Athletes tested for mild traumatic brain injury (mTBI) with no injury using the I-PAS goggles Receives: Device: I-PAS Goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with mTBI
How many participants were detected to have mTBI following a sports-related injury
Measured: 45 months
Secondary outcomes (1)
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
Measured: 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start19 Mar 2018
- Primary completion8 Apr 2019
- Study completion8 Apr 2019
Why it stopped: Inability to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Syneos Health, Neurolign
- Responsible party
- Principal investigator, Michael E. Hoffer, University of Miami
- Investigators
- Michael Hoffer, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515967
- Sponsor's protocol ID
- 20170209
- Status last verified
- Jun 2020
- First submitted
- 23 Apr 2018
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28894835Balaban 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.
PubMed 27654131
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03515967
- Acronym / sponsor ID
- 20170209
- Conditions
- Brain Injuries, Traumatic
- Keywords
- concussion, mild traumatic brain injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Syneos Health, Neurolign
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injured Athletes | Experimental | Device: I-PAS GogglesAthletes tested for mild traumatic brain injury (mTBI) after injury using the I-PAS goggles |
| Non-Injured Athletes | Active comparator | Device: I-PAS GogglesAthletes tested for mild traumatic brain injury (mTBI) with no injury using the I-PAS goggles |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
- Participants from 18-90 years of age who are or have been engaged in Olympic level competitions as an active participant or team member.
- 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.
Key exclusion criteria (15 listed)
- History of brain injury resulting from a penetrating wound to the head.
- Presence of aphasia and/or inability to give informed consent for participation
- History of diagnosed neuropsychiatric disorders
- Documented neurodegenerative disorders
- Prior disorders of hearing and balance including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-PAS GogglesPortable, head-mounted display goggle system with integrated eye capture technology | Device | Injured Athletes, Non-Injured Athletes |
Primary outcome
Number of participants with mTBI
Time frame: 45 months
How many participants were detected to have mTBI following a sports-related injury
1 secondary outcome
Time to recover
Time frame: 45 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Background: PubMed 28894835Hoffer 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.
- Background: PubMed 27654131Balaban 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hoffer, MD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A study testing I-PAS Goggles in people with Brain Injuries, Traumatic, run by University of Miami.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with mTBI (time frame: 45 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515967, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020; AzTrials last refreshed its copy on 1 Nov 2026.