Trial Outcomes & Findings for Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT) (NCT NCT02483429)

Last Updated: 2025-12-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

130 participants

Primary outcome timeframe

30-day follow-up time point

Results posted on

2025-12-26

Participant Flow

Participant milestones

Participant milestones
Measure	VRT Care Patients randomized to video-oculography (VOG)-guided rapid triage (VRT) care will have an algorithm-determined patient-specific diagnosis and treatment pathway in the emergency department (ED). Participants will complete a 1-week in-person follow-up and a 1-month and 6-month phone follow-up. VRT Care: 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.	Standard of Care (SOC) 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.
Overall Study STARTED	65	65
Overall Study COMPLETED	57	56
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Reasons for withdrawal
Measure	VRT Care Patients randomized to video-oculography (VOG)-guided rapid triage (VRT) care will have an algorithm-determined patient-specific diagnosis and treatment pathway in the emergency department (ED). Participants will complete a 1-week in-person follow-up and a 1-month and 6-month phone follow-up. VRT Care: 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.	Standard of Care (SOC) 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.
Overall Study Incomplete 1-week follow-up (excluded from primary analysis)	8	9

Baseline Characteristics

Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage (AVERT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VRT Care n=65 Participants 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. VRT Care: 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.	Standard of Care (SOC) n=65 Participants 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.	Total n=130 Participants Total of all reporting groups
Age, Continuous	58.3 years STANDARD_DEVIATION 15.8 • n=30 Participants	60.1 years STANDARD_DEVIATION 14.3 • n=30 Participants	59.2 years STANDARD_DEVIATION 15.0 • n=60 Participants
Sex: Female, Male Female	36 Participants n=30 Participants	32 Participants n=30 Participants	68 Participants n=60 Participants
Sex: Female, Male Male	29 Participants n=30 Participants	33 Participants n=30 Participants	62 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=30 Participants	1 Participants n=30 Participants	6 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=30 Participants	63 Participants n=30 Participants	123 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	1 Participants n=30 Participants	1 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants
Race (NIH/OMB) Asian	3 Participants n=30 Participants	1 Participants n=30 Participants	4 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	1 Participants n=30 Participants	1 Participants n=60 Participants
Race (NIH/OMB) Black or African American	9 Participants n=30 Participants	10 Participants n=30 Participants	19 Participants n=60 Participants
Race (NIH/OMB) White	48 Participants n=30 Participants	52 Participants n=30 Participants	100 Participants n=60 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=30 Participants	1 Participants n=30 Participants	5 Participants n=60 Participants
Region of Enrollment United States	65 Participants n=30 Participants	65 Participants n=30 Participants	130 Participants n=60 Participants

PRIMARY outcome

Timeframe: 30-day follow-up time point

Population: Randomized participants (n=130) who had complete 1-week follow-up testing (n=113) that included, at a minimum, in-person vestibular specialist exam, repeat VOG assessment, and MRI with diffusion-weighted images for ischemic stroke detection.

Outcome measures

Outcome measures
Measure	VOG-guided Rapid Triage (VRT) Care n=57 Participants Participants in both trial arms underwent video-oculography (VOG) testing to analyze their eye movements and were then randomized either to have VOG results algorithmically analyzed in real time and incorporated into their emergency department (ED) care process or for the VOG results not to be analyzed until a later date (i.e., during the trial's delayed diagnosis adjudication procedures). Participants completed a 1-week in-person follow-up, a 1-month phone follow-up, and a 1-month medical record review. Those completing the required 1-week follow-up testing (in-person vestibular specialist examination, repeat VOG testing, and follow-up MRI for ischemic stroke detection) were eligible for the primary analysis of the main trial outcomes as prespecified in the AVERT protocol at the trial's outset. VRT Care: Participants randomized to VRT (VOG-guided Rapid Triage) care received an automated algorithm-determined, patient-specific diagnosis and treatment pathway in the ED based on VOG testing. Automated algorithm outputs were reviewed for safety by an on-call trial physician before being incorporated into the patient's ED care process. The VOG report included direct device output (physiologic traces, quantitative measures) plus an algorithmically generated most likely diagnosis, diagnosis category (peripheral, equivocal, central), and diagnosis-specific clinical trial care pathway instructions. The VOG report was incorporated into the patient's ED care and clinical record.	Standard of Care (SOC) Care n=56 Participants Participants in both trial arms underwent video-oculography (VOG) testing to analyze their eye movements and were then randomized either to have VOG results algorithmically analyzed in real time and incorporated into their emergency department (ED) care process or for the VOG results not to be analyzed until a later date (i.e., during the trial's delayed diagnosis adjudication procedures). Participants completed a 1-week in-person follow-up, a 1-month phone follow-up, and a 1-month medical record review. Those completing the required 1-week follow-up testing (in-person vestibular specialist examination, repeat VOG testing, and follow-up MRI for ischemic stroke detection) were eligible for the primary analysis of the main trial outcomes as prespecified in the AVERT protocol at the trial's outset. SOC Care: Participants randomized to SOC (Standard of Care) care received usual ED care without VOG test results or interpretations being revealed to the ED care team. ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations.
VRT vs. ED SOC Six-Category Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison) Participants with an incorrect ED index visit diagnosis	33 Participants	38 Participants
VRT vs. ED SOC Six-Category Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison) Participants with a correct ED index visit diagnosis	24 Participants	18 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VOG-guided Rapid Triage (VRT) Care n=57 Participants Participants in both trial arms underwent video-oculography (VOG) testing to analyze their eye movements and were then randomized either to have VOG results algorithmically analyzed in real time and incorporated into their emergency department (ED) care process or for the VOG results not to be analyzed until a later date (i.e., during the trial's delayed diagnosis adjudication procedures). Participants completed a 1-week in-person follow-up, a 1-month phone follow-up, and a 1-month medical record review. Those completing the required 1-week follow-up testing (in-person vestibular specialist examination, repeat VOG testing, and follow-up MRI for ischemic stroke detection) were eligible for the primary analysis of the main trial outcomes as prespecified in the AVERT protocol at the trial's outset. VRT Care: Participants randomized to VRT (VOG-guided Rapid Triage) care received an automated algorithm-determined, patient-specific diagnosis and treatment pathway in the ED based on VOG testing. Automated algorithm outputs were reviewed for safety by an on-call trial physician before being incorporated into the patient's ED care process. The VOG report included direct device output (physiologic traces, quantitative measures) plus an algorithmically generated most likely diagnosis, diagnosis category (peripheral, equivocal, central), and diagnosis-specific clinical trial care pathway instructions. The VOG report was incorporated into the patient's ED care and clinical record.	Standard of Care (SOC) Care n=56 Participants Participants in both trial arms underwent video-oculography (VOG) testing to analyze their eye movements and were then randomized either to have VOG results algorithmically analyzed in real time and incorporated into their emergency department (ED) care process or for the VOG results not to be analyzed until a later date (i.e., during the trial's delayed diagnosis adjudication procedures). Participants completed a 1-week in-person follow-up, a 1-month phone follow-up, and a 1-month medical record review. Those completing the required 1-week follow-up testing (in-person vestibular specialist examination, repeat VOG testing, and follow-up MRI for ischemic stroke detection) were eligible for the primary analysis of the main trial outcomes as prespecified in the AVERT protocol at the trial's outset. SOC Care: Participants randomized to SOC (Standard of Care) care received usual ED care without VOG test results or interpretations being revealed to the ED care team. ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations.
VRT vs. ED SOC Total Diagnostic Utilization Costs at the ED Index Visit (Primary Analysis-eligible Participants, Two-arm Comparison)	3007.1 US dollars Interval 2367.9 to 3646.3	3599.0 US dollars Interval 2986.1 to 4211.8

PRIMARY outcome

Timeframe: 1-week follow-up time point

Population: Randomized participants in the SOC Care trial arm (n=65) who had complete 1-week follow-up testing (n=56) that included, at a minimum, in-person vestibular specialist exam, repeat VOG assessment, and MRI with diffusion-weighted images for ischemic stroke detection.

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.

Outcome measures

Outcome measures
Measure	VOG-guided Rapid Triage (VRT) Care n=18 Participants Participants in both trial arms underwent video-oculography (VOG) testing to analyze their eye movements and were then randomized either to have VOG results algorithmically analyzed in real time and incorporated into their emergency department (ED) care process or for the VOG results not to be analyzed until a later date (i.e., during the trial's delayed diagnosis adjudication procedures). Participants completed a 1-week in-person follow-up, a 1-month phone follow-up, and a 1-month medical record review. Those completing the required 1-week follow-up testing (in-person vestibular specialist examination, repeat VOG testing, and follow-up MRI for ischemic stroke detection) were eligible for the primary analysis of the main trial outcomes as prespecified in the AVERT protocol at the trial's outset. VRT Care: Participants randomized to VRT (VOG-guided Rapid Triage) care received an automated algorithm-determined, patient-specific diagnosis and treatment pathway in the ED based on VOG testing. Automated algorithm outputs were reviewed for safety by an on-call trial physician before being incorporated into the patient's ED care process. The VOG report included direct device output (physiologic traces, quantitative measures) plus an algorithmically generated most likely diagnosis, diagnosis category (peripheral, equivocal, central), and diagnosis-specific clinical trial care pathway instructions. The VOG report was incorporated into the patient's ED care and clinical record.	Standard of Care (SOC) Care n=38 Participants Participants in both trial arms underwent video-oculography (VOG) testing to analyze their eye movements and were then randomized either to have VOG results algorithmically analyzed in real time and incorporated into their emergency department (ED) care process or for the VOG results not to be analyzed until a later date (i.e., during the trial's delayed diagnosis adjudication procedures). Participants completed a 1-week in-person follow-up, a 1-month phone follow-up, and a 1-month medical record review. Those completing the required 1-week follow-up testing (in-person vestibular specialist examination, repeat VOG testing, and follow-up MRI for ischemic stroke detection) were eligible for the primary analysis of the main trial outcomes as prespecified in the AVERT protocol at the trial's outset. SOC Care: Participants randomized to SOC (Standard of Care) care received usual ED care without VOG test results or interpretations being revealed to the ED care team. ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations.
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]) Participants with zero PMEIs	17 Participants	35 Participants
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]) Participants with one or more PMEIs	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 30-day follow-up time point

Population: Randomized participants in the SOC Care trial arm (n=65) who had a known final diagnosis (n=51).

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.

Outcome measures

Outcome measures
Measure	VOG-guided Rapid Triage (VRT) Care n=51 Participants Participants in both trial arms underwent video-oculography (VOG) testing to analyze their eye movements and were then randomized either to have VOG results algorithmically analyzed in real time and incorporated into their emergency department (ED) care process or for the VOG results not to be analyzed until a later date (i.e., during the trial's delayed diagnosis adjudication procedures). Participants completed a 1-week in-person follow-up, a 1-month phone follow-up, and a 1-month medical record review. Those completing the required 1-week follow-up testing (in-person vestibular specialist examination, repeat VOG testing, and follow-up MRI for ischemic stroke detection) were eligible for the primary analysis of the main trial outcomes as prespecified in the AVERT protocol at the trial's outset. VRT Care: Participants randomized to VRT (VOG-guided Rapid Triage) care received an automated algorithm-determined, patient-specific diagnosis and treatment pathway in the ED based on VOG testing. Automated algorithm outputs were reviewed for safety by an on-call trial physician before being incorporated into the patient's ED care process. The VOG report included direct device output (physiologic traces, quantitative measures) plus an algorithmically generated most likely diagnosis, diagnosis category (peripheral, equivocal, central), and diagnosis-specific clinical trial care pathway instructions. The VOG report was incorporated into the patient's ED care and clinical record.	Standard of Care (SOC) Care n=51 Participants Participants in both trial arms underwent video-oculography (VOG) testing to analyze their eye movements and were then randomized either to have VOG results algorithmically analyzed in real time and incorporated into their emergency department (ED) care process or for the VOG results not to be analyzed until a later date (i.e., during the trial's delayed diagnosis adjudication procedures). Participants completed a 1-week in-person follow-up, a 1-month phone follow-up, and a 1-month medical record review. Those completing the required 1-week follow-up testing (in-person vestibular specialist examination, repeat VOG testing, and follow-up MRI for ischemic stroke detection) were eligible for the primary analysis of the main trial outcomes as prespecified in the AVERT protocol at the trial's outset. SOC Care: Participants randomized to SOC (Standard of Care) care received usual ED care without VOG test results or interpretations being revealed to the ED care team. ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations.
Expert VOG vs. ED SOC Six-Category Diagnosis Accuracy (Participants With a Known Final Diagnosis, One-arm Comparison [SOC Arm Only]) Participants with a correct ED index visit diagnosis	29 Participants	13 Participants
Expert VOG vs. ED SOC Six-Category Diagnosis Accuracy (Participants With a Known Final Diagnosis, One-arm Comparison [SOC Arm Only]) Participants with an incorrect ED index visit diagnosis	22 Participants	38 Participants

SECONDARY outcome

Timeframe: 30-day follow-up time point

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.

Outcome measures

Outcome measures
Measure	VOG-guided Rapid Triage (VRT) Care n=54 Participants Participants in both trial arms underwent video-oculography (VOG) testing to analyze their eye movements and were then randomized either to have VOG results algorithmically analyzed in real time and incorporated into their emergency department (ED) care process or for the VOG results not to be analyzed until a later date (i.e., during the trial's delayed diagnosis adjudication procedures). Participants completed a 1-week in-person follow-up, a 1-month phone follow-up, and a 1-month medical record review. Those completing the required 1-week follow-up testing (in-person vestibular specialist examination, repeat VOG testing, and follow-up MRI for ischemic stroke detection) were eligible for the primary analysis of the main trial outcomes as prespecified in the AVERT protocol at the trial's outset. VRT Care: Participants randomized to VRT (VOG-guided Rapid Triage) care received an automated algorithm-determined, patient-specific diagnosis and treatment pathway in the ED based on VOG testing. Automated algorithm outputs were reviewed for safety by an on-call trial physician before being incorporated into the patient's ED care process. The VOG report included direct device output (physiologic traces, quantitative measures) plus an algorithmically generated most likely diagnosis, diagnosis category (peripheral, equivocal, central), and diagnosis-specific clinical trial care pathway instructions. The VOG report was incorporated into the patient's ED care and clinical record.	Standard of Care (SOC) Care n=46 Participants Participants in both trial arms underwent video-oculography (VOG) testing to analyze their eye movements and were then randomized either to have VOG results algorithmically analyzed in real time and incorporated into their emergency department (ED) care process or for the VOG results not to be analyzed until a later date (i.e., during the trial's delayed diagnosis adjudication procedures). Participants completed a 1-week in-person follow-up, a 1-month phone follow-up, and a 1-month medical record review. Those completing the required 1-week follow-up testing (in-person vestibular specialist examination, repeat VOG testing, and follow-up MRI for ischemic stroke detection) were eligible for the primary analysis of the main trial outcomes as prespecified in the AVERT protocol at the trial's outset. SOC Care: Participants randomized to SOC (Standard of Care) care received usual ED care without VOG test results or interpretations being revealed to the ED care team. ED SOC diagnoses were based on all clinical information from the ED index visit, including neuroimaging and consultations.
VRT vs. ED SOC Stroke-No Stroke Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison) Strokes: Participants with an incorrect ED index visit diagnosis	3 Participants	2 Participants
VRT vs. ED SOC Stroke-No Stroke Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison) Strokes: Participants with a correct ED index visit diagnosis	5 Participants	4 Participants
VRT vs. ED SOC Stroke-No Stroke Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison) Non-strokes: Participants with a correct ED index visit diagnosis	35 Participants	39 Participants
VRT vs. ED SOC Stroke-No Stroke Diagnosis Accuracy (Primary Analysis-eligible Participants, Two-arm Comparison) Non-strokes: Participants with an incorrect ED index visit diagnosis	11 Participants	1 Participants

Adverse Events

VRT Care

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Standard of Care (SOC)

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	VRT Care n=65 participants at risk 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. VRT Care: 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.	Standard of Care (SOC) n=65 participants at risk 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.
Injury, poisoning and procedural complications Transient increased dizziness, nausea, or vomiting during or immediately after VOG testing	61.5% 40/65 • Up to 30 days follow-up Events were assessed systematically during the ED index visit, 1-week follow-up visit, and 1-month follow-up call, and via medical record review. Events associated with VOG testing, as well as any reported test-related adverse events, were systematically tracked throughout the trial.	56.9% 37/65 • Up to 30 days follow-up Events were assessed systematically during the ED index visit, 1-week follow-up visit, and 1-month follow-up call, and via medical record review. Events associated with VOG testing, as well as any reported test-related adverse events, were systematically tracked throughout the trial.
Injury, poisoning and procedural complications Persistent increase in dizziness, nausea, vomiting, or gait unsteadiness after VOG testing	10.8% 7/65 • Up to 30 days follow-up Events were assessed systematically during the ED index visit, 1-week follow-up visit, and 1-month follow-up call, and via medical record review. Events associated with VOG testing, as well as any reported test-related adverse events, were systematically tracked throughout the trial.	16.9% 11/65 • Up to 30 days follow-up Events were assessed systematically during the ED index visit, 1-week follow-up visit, and 1-month follow-up call, and via medical record review. Events associated with VOG testing, as well as any reported test-related adverse events, were systematically tracked throughout the trial.
Injury, poisoning and procedural complications Transient fatigue or malaise during or immediately after VOG testing	12.3% 8/65 • Up to 30 days follow-up Events were assessed systematically during the ED index visit, 1-week follow-up visit, and 1-month follow-up call, and via medical record review. Events associated with VOG testing, as well as any reported test-related adverse events, were systematically tracked throughout the trial.	20.0% 13/65 • Up to 30 days follow-up Events were assessed systematically during the ED index visit, 1-week follow-up visit, and 1-month follow-up call, and via medical record review. Events associated with VOG testing, as well as any reported test-related adverse events, were systematically tracked throughout the trial.
Injury, poisoning and procedural complications Transient neck discomfort during or immediately after VOG testing	10.8% 7/65 • Up to 30 days follow-up Events were assessed systematically during the ED index visit, 1-week follow-up visit, and 1-month follow-up call, and via medical record review. Events associated with VOG testing, as well as any reported test-related adverse events, were systematically tracked throughout the trial.	16.9% 11/65 • Up to 30 days follow-up Events were assessed systematically during the ED index visit, 1-week follow-up visit, and 1-month follow-up call, and via medical record review. Events associated with VOG testing, as well as any reported test-related adverse events, were systematically tracked throughout the trial.
Injury, poisoning and procedural complications Transient discomfort where the goggles sit or mild headache during or immediately after VOG testing	30.8% 20/65 • Up to 30 days follow-up Events were assessed systematically during the ED index visit, 1-week follow-up visit, and 1-month follow-up call, and via medical record review. Events associated with VOG testing, as well as any reported test-related adverse events, were systematically tracked throughout the trial.	26.2% 17/65 • Up to 30 days follow-up Events were assessed systematically during the ED index visit, 1-week follow-up visit, and 1-month follow-up call, and via medical record review. Events associated with VOG testing, as well as any reported test-related adverse events, were systematically tracked throughout the trial.
Injury, poisoning and procedural complications Mild skin irritation (including eyelid) from sticky eyepatch or goggles foam insert for VOG testing	3.1% 2/65 • Up to 30 days follow-up Events were assessed systematically during the ED index visit, 1-week follow-up visit, and 1-month follow-up call, and via medical record review. Events associated with VOG testing, as well as any reported test-related adverse events, were systematically tracked throughout the trial.	7.7% 5/65 • Up to 30 days follow-up Events were assessed systematically during the ED index visit, 1-week follow-up visit, and 1-month follow-up call, and via medical record review. Events associated with VOG testing, as well as any reported test-related adverse events, were systematically tracked throughout the trial.

Additional Information

David E. Newman-Toker

Johns Hopkins University

Phone: 443-287-9593

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place