VertigoPhase 2AVERTNCT02483429
Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT)
A Phase 2 study testing VRT Care in people with Vertigo and Dizziness, run by Johns Hopkins University at 5 sites in United States.
Trial summary
AVERT is a randomized controlled trial comparing video-oculography (VOG)-guided care to standard care to assess accuracy of diagnoses and initial management decisions for emergency department (ED) patients with a chief symptom of vertigo or dizziness suspected to be of vestibular cause. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- VRT Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Dec 2017to 17 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 years and older) ED patients with all of the following (all determined pre-randomization):
- VESTIBULAR SYMPTOMS: presenting symptom of "vertigo" OR "dizziness" OR "unsteadiness" (as defined by consensus expert definitions in the International Classification of Vestibular Disorders).
- RELEVANT EXAM SIGNS*: pathologic nystagmus (spontaneous, gaze-evoked, or positional) by bedside VOG testing OR pathologic ataxia (gait, trunk, stance, limbs) by bedside ataxia examination.
- RECENT ONSET: symptoms AND signs* appear to be new or markedly worse in the past month. (*Exam signs are required for randomization, but not for the observational arm)
Who cannot join
- Excluded from Pre-Randomization Screening
- Level 1 trauma or critical illness
- Altered mental status (e.g., delirium, dementia) that would preclude active study participation (this includes patients with abnormal mental state due to alcohol intoxication or illicit substance, which are known, easily-recognized causes of dizziness or vertigo presentations to the ED)
- Non-English speaking (enrollment of non-English speakers is not feasible given the logistics of identifying a translator and the need for rapid recruitment and randomization in the AVERT study; furthermore, the terms vertigo, dizziness, and unsteadiness may have different meanings in other languages)
- Known pregnancy (all women of childbearing age who are enrolled will undergo a urine or serum beta human chorionic gonadotropin [hCG] pregnancy test prior to MRI to confirm no pregnancy, per local institutional guidelines)
- Unable or unsafe to participate in screening, including VOG tests (as deemed by specific pre-enrollment risk assessment questions or ED provider and/or Study Coordinator judgment) including, but not limited to:
Show all 17Show fewer
- visual impairment sufficient to prevent visual fixation during the VOG testing
- clinically-perceived risk to patient of participating in study (ED provider or staff concerns)
- clinically-perceived risk to research staff (e.g., violence, blood/body fluid/respiratory precautions)
- unstable cardiac status (given a single reported case of bradycardia with impulse testing)
- acute cranio-cervical trauma or other condition (e.g., rheumatoid arthritis) that might lead to instability of the cervical spine that would be a contraindication to neck rotation during VOG testing
- Obvious general medical cause (as judged by treating ED provider) including, but not limited to, acute myocardial infarction, pulmonary embolus, pneumonia, urinary tract infection, drug intoxication, etc.
- Excluded from Randomization (Eligible for Observational Arm Follow-up)
- Patient previously randomized in the AVERT Trial (previously screened but not randomized are eligible)
- Unable to participate fully with study follow-up (particularly MRI) including, but not limited to:
- unable to return for follow-up testing within 30 days
- unable to undergo MRI because of contraindications (e.g., pacemaker, metallic foreign body, pregnancy) or other reasons (severe claustrophobia, too large or too heavy for MRI scanner)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins Hospital - Bayview
Baltimore, Maryland, 21224
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mt. Sinai Medical Center
New York, New York, 10029
University of Illinois
Peoria, Illinois, 61656
About this study
AVERT is a randomized controlled trial comparing video-oculography (VOG)-guided care to standard care to assess accuracy of diagnoses and initial management decisions for emergency department (ED) patients with a chief symptom of vertigo or dizziness suspected to be of vestibular cause. The trial will test the hypothesis that VOG-guided rapid triage (VRT) will accurately, safely, and efficiently differentiate peripheral from central vestibular disorders in ED patients presenting acute vertigo or dizziness, and that doing so has the potential to improve post-treatment clinical outcomes for these patients.
Read the detailed description
AVERT is a multicenter phase 2 clinical trial comparing a novel diagnostic strategy (VRT) to standard ED diagnostic care at three performance sites. The Specific Aims are to assess diagnostic accuracy, diagnostic workup costs, and estimate the short-term impact of correct diagnosis in anticipation of a larger, definitive phase 3 trial. Adult ED patients with a chief symptom of vertigo, dizziness, or unsteadiness, new or clearly worse in the previous 30 days, will undergo on-site vestibular function tests by trained research personnel using a portable, quantitative VOG recording device. Research personnel will also record a focused symptom history and bedside hearing tests. Eligible patients with at least one pathologic vestibular eye movement finding or pathologic ataxia will be randomized to VRT or standard ED care. Patients eligible for pre-randomization testing but excluded from randomization will be slated for the Observational Arm of the study and will undergo limited 1-month and 6-month phone follow-up. The VRT arm relies on an automated algorithm to interpret VOG results, thereby determining a patient-specific clinical care pathway. For safety, all VRT-arm study participants will undergo stroke protocol MRI before release. All randomized participants will undergo confirmatory testing at one week, including vestibular specialist exam and 1.5 or 3-Tesla research MRI combining stroke and internal auditory canal protocols. All randomized participants will also undergo 1-month and 6-month phone follow-up and medical record review to confirm diagnoses. Clinical findings, ED diagnoses, diagnostic resource utilization, treatments applied, and clinical events during follow-up will be recorded. A multidisciplinary, masked expert panel will adjudicate final diagnoses.
- Being tested
- VRT Care
- Keywords
- Vertigo, Dizziness, Unsteadiness, Stroke, Vestibular neuritis, Benign paroxysmal positional vertigo, Vestibulo-ocular reflex, Video-oculography, Emergency department
- Medical subject headings
- Vertigo, Dizziness, Stroke, Vestibular Neuronitis, Benign Paroxysmal Positional Vertigo, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRT CareDevice
Also called GN Otometrics (Instrumentation & Control Systems, Inc)
The VOG report includes direct device output (physiologic traces, quantitative measures) plus most likely diagnosis, category, and clinical trial care pathway (peripheral, equivocal, central) instructions. The VOG report becomes part of the patient's emergency department clinical record.
| Study group | Role | What they receive |
|---|---|---|
| VRT Care | Experimental | Patients randomized to VRT (VOG-guided Rapid Triage) care will have an algorithm-determined patient-specific diagnosis and treatment pathway in the emergency department. Participants will complete a 1-week in-person follow-up and a 1-month and 6-month phone follow-up. Receives: Device: VRT Care |
| Standard of Care (SOC) | No intervention | Patients randomized to Standard of Care will undergo usual emergency department care without revealing results of VOG testing. Participants will complete a 1-week in-person follow-up and a 1-month and 6-month phone follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VRT vs. ED SOC Six-Category Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison)
Total diagnosis accuracy VRT vs. ED SOC using 30-day adjudicated final diagnoses categorized in one of six diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). VRT diagnoses were based on automated interpretation of ED index VOG tests in the context of structured medical history information and examination findings from the ED index visit (clinically supervised for safety), while ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations. Final diagnoses were based on ED index visit, 1-week, and 30-day follow-up clinical assessments. The population was limited to those with complete 1-week follow-up testing including in-person vestibular specialist exam, repeat VOG assessment, and MRI with diffusion-weighted images for ischemic stroke detection.
Measured: 30-day follow-up time point
VRT vs. ED SOC Total Diagnostic Utilization Costs at the ED Index Visit (Primary Analysis-eligible Participants, Two-arm Comparison)
Total US dollar costs VRT vs. ED SOC for diagnostic tests and consultations obtained during the ED index visit and associated hospital admission (for those admitted at the index visit). For the VRT arm, this does not include costs of safety MRIs required by the institutional review board (IRB)-approved protocol or any tests ordered "off protocol" by ED physicians (i.e., it represents VRT-recommended utilization-based costs); however, it does include tests, consultations, or admissions ordered "on protocol" by consultants or ED physicians in the VRT "equivocal" diagnosis pathway. For the SOC arm, this includes all utilization-related costs from the ED index visit (tests, consultations, or admissions). Total costs are calculated by multiplying fixed cost estimates (2025 national average Medicare reimbursement in US dollars) by utilization rates for each ED index visit service tracked.
Measured: 30-day follow-up time point
Participants With Short-Term Prespecified Medical Event(s) of Interest (PMEIs) After a Correct vs. Incorrect Diagnosis (Primary Analysis-eligible Participants, One-arm Comparison [SOC Arm Only])
PMEIs included ED revisits, falls, vascular events, and test or treatment complications. PMEIs occurring between the ED index visit disposition and 1-week follow-up visit (after which the two arms joined the same diagnostic pathway) were considered. Events diagnosed at ED index visit were not counted. Events newly diagnosed at 1-week follow-up or in the interval prior to 1-week follow-up were counted, regardless of relatedness to ED index dizziness symptoms, with the exception of test or treatment complications, which were required to be related directly or indirectly to the dizziness symptoms. To avoid "double counting" misdiagnoses as follow-on PMEIs pursuant to an initial misdiagnosis, 1-week stroke diagnoses not rendered at the ED index visit were not counted unless neurologic or vestibular symptoms/signs worsened after the ED index visit. Six-category accuracy was used to determine "correct" vs. "incorrect" index ED SOC diagnoses relative to 30-day adjudicated final diagnoses.
Measured: 1-week follow-up time point
Secondary outcomes (2)
Expert VOG vs. ED SOC Six-Category Diagnosis Accuracy (Participants With a Known Final Diagnosis, One-arm Comparison [SOC Arm Only])
Total diagnosis accuracy Expert VOG vs. ED SOC using 30-day adjudicated final diagnoses categorized in one of six diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). Expert VOG diagnoses were based on masked interpretation of ED index VOG tests in the context of basic demographic and medical history information from the ED index visit, while ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations. Final diagnoses were based on ED index visit, 1-week, and 30-day follow-up clinical assessments. The SOC arm population was limited to those with known final diagnoses to avoid counting as "incorrect" cases with unknown final diagnoses after 30-day follow-up. This within-subject comparison reflects current potential accuracy of expert VOG-based tele-diagnosis and the targeted maximum diagnostic accuracy (i.e., expert level performance) for future automated algorithms, relative to current care.
Measured: 30-day follow-up time point
VRT vs. ED SOC Stroke-No Stroke Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison)
Total diagnosis accuracy VRT vs. ED SOC using 30-day adjudicated final diagnoses categorized as stroke (any cerebrovascular event) versus no stroke (including peripheral vestibular, medical, psychiatric, or other central neurologic causes such as multiple sclerosis, traumatic brain injury, epilepsy, or anticonvulsant toxicity). "Index VRT Diagnosis" and "ED SOC Diagnosis" were compared to the "Adjudicated Final Diagnosis" based on ED index visit and 30-day follow-up clinical assessments.
Measured: 30-day follow-up time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start4 Dec 2017
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VertigoStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), GN Otometrics
- Responsible party
- Sponsor
- Investigators
- David Newman-Toker, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483429
- Sponsor's protocol ID
- IRB00044228
- Other IDs
- 1U01DC013778-01A1
- Acronym
- AVERT
- Status last verified
- Dec 2025
- First submitted
- 3 Mar 2015
- Last updated
- 26 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Edlow JA, Carpenter C, Akhter M, Khoujah D, Marcolini E, Meurer WJ, Morrill D, Naples JG, Ohle R, Omron R, Sharif S, Siket M, Upadhye S, E Silva LOJ, Sundberg E, Tartt K, Vanni S, Newman-Toker DE, Bellolio F. Guidelines for reasonable and appropriate care in the emergency department 3 (GRACE-3): Acute dizziness and vertigo in the emergency department. Acad Emerg Med. 2023 May;30(5):442-486. doi: 10.1111/acem.14728.
PubMed 37166022Kotwal S, Fanai M, Fu W, Wang Z, Bery AK, Omron R, Tevzadze N, Gold D, Garibaldi BT, Wright SM, Newman-Toker DE. Real-world virtual patient simulation to improve diagnostic performance through deliberate practice: a prospective quasi-experimental study. Diagnosis (Berl). 2021 Mar 8;8(4):489-496. doi: 10.1515/dx-2020-0127. Print 2021 Nov 25.
PubMed 33675203
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT)
- ClinicalTrials.gov ID
- NCT02483429
- Acronym / sponsor ID
- AVERT / IRB00044228
- Keywords
- Vertigo, Dizziness, Unsteadiness, Stroke, Vestibular neuritis, Benign paroxysmal positional vertigo, Vestibulo-ocular reflex, Video-oculography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), GN Otometrics
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Posted 9 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AVERT is a randomized controlled trial comparing video-oculography (VOG)-guided care to standard care to assess accuracy of diagnoses and initial management decisions for emergency department (ED) patients with a chief symptom of vertigo or dizziness suspected to be of vestibular cause. The trial will test the hypothesis that VOG-guided rapid triage (VRT) will accurately, safely, and efficiently differentiate peripheral from central vestibular disorders in ED patients presenting acute vertigo or dizziness, and that doing so has the potential to improve post-treatment clinical outcomes for these patients.
Detailed description
AVERT is a multicenter phase 2 clinical trial comparing a novel diagnostic strategy (VRT) to standard ED diagnostic care at three performance sites. The Specific Aims are to assess diagnostic accuracy, diagnostic workup costs, and estimate the short-term impact of correct diagnosis in anticipation of a larger, definitive phase 3 trial. Adult ED patients with a chief symptom of vertigo, dizziness, or unsteadiness, new or clearly worse in the previous 30 days, will undergo on-site vestibular function tests by trained research personnel using a portable, quantitative VOG recording device. Research personnel will also record a focused symptom history and bedside hearing tests. Eligible patients with at least one pathologic vestibular eye movement finding or pathologic ataxia will be randomized to VRT or standard ED care. Patients eligible for pre-randomization testing but excluded from randomization will be slated for the Observational Arm of the study and will undergo limited 1-month and 6-month phone follow-up. The VRT arm relies on an automated algorithm to interpret VOG results, thereby determining a patient-specific clinical care pathway. For safety, all VRT-arm study participants will undergo stroke protocol MRI before release. All randomized participants will undergo confirmatory testing at one week, including vestibular specialist exam and 1.5 or 3-Tesla research MRI combining stroke and internal auditory canal protocols. All randomized participants will also undergo 1-month and 6-month phone follow-up and medical record review to confirm diagnoses. Clinical findings, ED diagnoses, diagnostic resource utilization, treatments applied, and clinical events during follow-up will be recorded. A multidisciplinary, masked expert panel will adjudicate final diagnoses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRT Care | Experimental | Device: VRT CarePatients randomized to VRT (VOG-guided Rapid Triage) care will have an algorithm-determined patient-specific diagnosis and treatment pathway in the emergency department. Participants will complete a 1-week in-person follow-up and a 1-month and 6-month phone follow-up. |
| Standard of Care (SOC) | No intervention | –Patients randomized to Standard of Care will undergo usual emergency department care without revealing results of VOG testing. Participants will complete a 1-week in-person follow-up and a 1-month and 6-month phone follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (18 years and older) ED patients with all of the following (all determined pre-randomization):
- VESTIBULAR SYMPTOMS: presenting symptom of "vertigo" OR "dizziness" OR "unsteadiness" (as defined by consensus expert definitions in the International Classification of Vestibular Disorders).
- RELEVANT EXAM SIGNS*: pathologic nystagmus (spontaneous, gaze-evoked, or positional) by bedside VOG testing OR pathologic ataxia (gait, trunk, stance, limbs) by bedside ataxia examination.
- RECENT ONSET: symptoms AND signs* appear to be new or markedly worse in the past month. (*Exam signs are required for randomization, but not for the observational arm)
Key exclusion criteria (17 listed)
- Excluded from Pre-Randomization Screening
- Excluded from Randomization (Eligible for Observational Arm Follow-up)
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 |
|---|---|---|
| VRT CareAlso: GN Otometrics (Instrumentation & Control Systems, Inc)The VOG report includes direct device output (physiologic traces, quantitative measures) plus most likely diagnosis, category, and clinical trial care pathway (peripheral, equivocal, central) instructions. The VOG report becomes part of the patient's emergency department clinical record. | Device | VRT Care |
Primary outcome
VRT vs. ED SOC Six-Category Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison)
Time frame: 30-day follow-up time point
Total diagnosis accuracy VRT vs. ED SOC using 30-day adjudicated final diagnoses categorized in one of six diagnosis categories (3 peripheral, 1 central, 1 medical/other, 1 non-diagnosis). VRT diagnoses were based on automated interpretation of ED index VOG tests in the context of structured medical history information and examination findings from the ED index visit (clinically supervised for safety), while ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations. Final diagnoses were based on ED index visit, 1-week, and 30-day follow-up clinical assessments. The population was limited to those with complete 1-week follow-up testing including in-person vestibular specialist exam, repeat VOG assessment, and MRI with diffusion-weighted images for ischemic stroke detection.
VRT vs. ED SOC Total Diagnostic Utilization Costs at the ED Index Visit (Primary Analysis-eligible Participants, Two-arm Comparison)
Time frame: 30-day follow-up time point
Total US dollar costs VRT vs. ED SOC for diagnostic tests and consultations obtained during the ED index visit and associated hospital admission (for those admitted at the index visit). For the VRT arm, this does not include costs of safety MRIs required by the institutional review board (IRB)-approved protocol or any tests ordered "off protocol" by ED physicians (i.e., it represents VRT-recommended utilization-based costs); however, it does include tests, consultations, or admissions ordered "on protocol" by consultants or ED physicians in the VRT "equivocal" diagnosis pathway. For the SOC arm, this includes all utilization-related costs from the ED index visit (tests, consultations, or admissions). Total costs are calculated by multiplying fixed cost estimates (2025 national average Medicare reimbursement in US dollars) by utilization rates for each ED index visit service tracked.
Participants With Short-Term Prespecified Medical Event(s) of Interest (PMEIs) After a Correct vs. Incorrect Diagnosis (Primary Analysis-eligible Participants, One-arm Comparison [SOC Arm Only])
Time frame: 1-week follow-up time point
PMEIs included ED revisits, falls, vascular events, and test or treatment complications. PMEIs occurring between the ED index visit disposition and 1-week follow-up visit (after which the two arms joined the same diagnostic pathway) were considered. Events diagnosed at ED index visit were not counted. Events newly diagnosed at 1-week follow-up or in the interval prior to 1-week follow-up were counted, regardless of relatedness to ED index dizziness symptoms, with the exception of test or treatment complications, which were required to be related directly or indirectly to the dizziness symptoms. To avoid "double counting" misdiagnoses as follow-on PMEIs pursuant to an initial misdiagnosis, 1-week stroke diagnoses not rendered at the ED index visit were not counted unless neurologic or vestibular symptoms/signs worsened after the ED index visit. Six-category accuracy was used to determine "correct" vs. "incorrect" index ED SOC diagnoses relative to 30-day adjudicated final diagnoses.
2 secondary outcomes
Expert VOG vs. ED SOC Six-Category Diagnosis Accuracy (Participants With a Known Final Diagnosis, One-arm Comparison [SOC Arm Only])
Time frame: 30-day follow-up time point
VRT vs. ED SOC Stroke-No Stroke Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison)
Time frame: 30-day follow-up time point
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37166022Edlow JA, Carpenter C, Akhter M, Khoujah D, Marcolini E, Meurer WJ, Morrill D, Naples JG, Ohle R, Omron R, Sharif S, Siket M, Upadhye S, E Silva LOJ, Sundberg E, Tartt K, Vanni S, Newman-Toker DE, Bellolio F. Guidelines for reasonable and appropriate care in the emergency department 3 (GRACE-3): Acute dizziness and vertigo in the emergency department. Acad Emerg Med. 2023 May;30(5):442-486. doi: 10.1111/acem.14728.
- Derived from this study: PubMed 33675203Kotwal S, Fanai M, Fu W, Wang Z, Bery AK, Omron R, Tevzadze N, Gold D, Garibaldi BT, Wright SM, Newman-Toker DE. Real-world virtual patient simulation to improve diagnostic performance through deliberate practice: a prospective quasi-experimental study. Diagnosis (Berl). 2021 Mar 8;8(4):489-496. doi: 10.1515/dx-2020-0127. Print 2021 Nov 25.
- Brain Injury OutcomeS (BIOS) websiteLink provided by the sponsor.
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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.
David Newman-Toker, MD, PhD principal investigator
Johns Hopkins University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VRT Care in people with Vertigo and Dizziness, run by Johns Hopkins University at 5 sites in United States.
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 4 inclusion and 17 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: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
VRT vs. ED SOC Six-Category Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison) (time frame: 30-day follow-up time point). The study lists 3 primary outcomes in all. 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 NCT02483429, 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 Dec 2025.