Mild Traumatic Brain InjuryINVENTNCT03846830
Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
A study testing Incremental Velocity Error (IVE) and Traditional Vestibular Rehabilitation (VPT) in people with Mild Traumatic Brain Injury and Vestibular Neuropathy, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The objective for this study is to compare outcome measures from vestibular rehabilitation (VPT) delivered in a traditional method against a new device Incremental Velocity Error (IVE) that improves physiologic performance of the vestibulo-ocular reflex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury, Vestibular Neuropathy
- What is being tested?
- Incremental Velocity Error (IVE) and Traditional Vestibular Rehabilitation (VPT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Oct 2021to 1 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 18 years old
- Service members with mTBI and civilian patients with vestibular hypofunction, both of which reports vestibular symptoms (i.e. dizziness, imbalance).
Who cannot join
- Any subjects with a self-reported history of significant ophthalmic, neuromuscular, cardiovascular (except hypertension), renal/electrolyte and psychiatric disorders
- Those with uncontrolled severe hypertension (systolic BP of >200 mm Hg and/or a diastolic BP of > 110 mmHg at rest)
- Those with a recent history of alcohol and/or drug abuse within the past 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Fort Belvoir CH
Fort Belvoir, Virginia, 22060
About this study
Official title: INVENT VPT: Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
The objective for this study is to compare outcome measures from vestibular rehabilitation (VPT) delivered in a traditional method against a new device Incremental Velocity Error (IVE) that improves physiologic performance of the vestibulo-ocular reflex. Participants include active duty service members with mild traumatic brain injury (mTBI) and civilians with peripheral vestibular hypofunction. The investigators will use a clinical trial cross-over design with randomization to either the control (VPT) or experimental (IVE) group and measure vestibulo-ocular reflex function as well as subjective and functional outcomes in order to investigate the best means to improve delivery of vestibular rehabilitation.
- Conditions
- Mild Traumatic Brain Injury, Vestibular Neuropathy
- Being tested
- Incremental Velocity Error (IVE), Traditional Vestibular Rehabilitation (VPT)
- Keywords
- gaze stability, balance, vestibulo-ocular reflex (VOR) gain, dizzy
- Medical subject headings
- Brain Concussion, Vestibular Neuronitis, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental Velocity Error (IVE)Device
A lightweight headband has electronics attached that detect head velocity and move a laser target at a fraction of the head velocity.
Traditional Vestibular Rehabilitation (VPT)Behavioural
Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance.
| Study group | Role | What they receive |
|---|---|---|
| IVE/VPT 6 week Crossover | Active comparator | Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 5 weeks, 6 weeks washout, and then crossover into the other group for a final 5 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout each of the 5 weeks epochs of training. Receives: Device: Incremental Velocity Error (IVE); Behavioral: Traditional Vestibular Rehabilitation (VPT) |
| IVE/VPT 3 week Crossover | Experimental | Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training will not start until the washout period. Receives: Device: Incremental Velocity Error (IVE); Behavioral: Traditional Vestibular Rehabilitation (VPT) |
| IVE/VPT 3 week crossover | Active comparator | Subjects will randomly be placed in one of two groups (IVE or VPT) involving every other day exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout the 3 weeks of exercise. Receives: Device: Incremental Velocity Error (IVE); Behavioral: Traditional Vestibular Rehabilitation (VPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vestibulo-ocular reflex (VOR) Gain
A ratio of eye/head velocity measured using a small video camera attached to a lightweight headband. This is an off-the-shelf device commonly used in clinic. Scores typically vary between 0 and 1.2 and normal ranges are between 0.8 and 1.2.
Measured: Weekly, up to 6 months
Secondary outcomes (28)
Baseline vestibular function assessed with Videonystagmography/Electronystagmography (VNG/ENG)
The VNG/ENG is a suite of tests that measure oculomotor function and vestibular function by asking subjects to follow moving targets while the eyes are recording with video (VNG) or electrodes (ENG). Also included is a warm and cold air flush into the external ear, which stimulates the 8th cranial nerve. The report includes measures of eye velocity (deg/sec), position, (deg) and acceleration (deg/sec/sec) relative to the moving targets. These data are presented in a plot that is compared to normative values provided by the company to assess baseline vestibular function.
Measured: At first visit, up to 30 minutes.
Baseline oculomotor function assessed with Videonystagmography/Electronystagmography (VNG/ENG)
This is a standard clinical test being done to characterize baseline vestibular function.
The VNG/ENG is a suite of tests that measure oculomotor function and vestibular function by asking subjects to follow moving targets while the eyes are recording with video (VNG) or electrodes (ENG). Also included is a warm and cold air flush into the external ear, which stimulates the 8th cranial nerve. The report includes measures of eye velocity (deg/sec), position, (deg) and acceleration (deg/sec/sec) relative to the moving targets. Data also includes velocity of eye rotations relative to healthy controls. These data are presented in a plot that is compared to normative values provided by the company to assess baseline oculomotor function.
Measured: At first visit, up to 30 minutes.
Baseline vestibular function assessed with Vestibular Evoked Myogenic Potential (VEMP)
This is a standard clinical test being done to characterize baseline vestibular function. The VEMP test uses surface electromyography to record sternocleidomastoid and/or inferior oblique muscle activity. The report output is the latency and magnitude of the muscle response. These data are presented in a plot that is compared to normative values provided by the company to assess baseline vestibular function.
Measured: At first visit, up to 20 minutes.
Baseline vestibular function assessed with Rotary Chair
This is a standard clinical test being done to characterize baseline vestibular function. The Rotary Chair test positions subjects in an enclosure, seated in a chair that moves 360deg at 60 and 240 deg/sec. The report includes measures of eye and head velocity (deg/sec) and position (deg). These data are presented in a plot that is compared to normative values provided by the company to assess baseline vestibular function.
Measured: At first visit, up to 40 minutes.
Change in Dizziness Handicap Inventory
This is a questionnaire filled out by the subject that includes items describing the behavioral impact of experiencing dizziness/imbalance. Each items is scored as a Likert scale type variable where subjects answer Yes Sometimes or No. Scores range from 0-100, with 0 indicating no impact of dizziness while scores of 100 indicate a severe impact.
Measured: Every other week, up to 6 months
Change in Activity Specific Balance Confidence scale (ABC)
Self-report measure that asks subjects to rate their confidence performing 16 activities of daily living. Each item is scored from 0 to 100% in 10% increments with 0% indicating No confidence and 100% indicating Complete confidence.
Measured: Every other week, up to 6 months
Change in Neurobehavioral Symptom Inventory (NSI)
This is a 22 item questionnaire that asks how bothersome symptoms are. Items are scored from 0 (None) to 4 (Very Severe). HIgher scores imply the symptoms are more bothersome.
Measured: Every other week, up to 6 months
Change in Patient Global Impression of Change (PGIC)
This is a questionnaire filled out by the subject that assesses change in activity, symptoms, emotions, and overall quality of life. Items are between 1 (no change) to 7 (considerable) and higher scores suggest a better change in symptom management.
Measured: Every other week, up to 6 months
Change in Dynamic Visual Acuity (DVA)
This is a standard clinical test of visual acuity during active (self-generated) head rotation. Subjects identify letters on a computer monitor; scores range from 20/10 acuity to 20/800 and normative data are available to compare.
Measured: Every other week, up to 6 months
Change in Time ( in seconds) Standing during the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Subjects stand quietly (arms folded) on the ground or on a compliant surface while time is measured up to 30 seconds. This is a standard measure of standing posture/balance. Each participant gets a score ranging from 0 to 30 seconds with higher scores correlating with a better balance.
Measured: Every other week, up to 6 months
Change in Area (in degrees) of Sway during the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Subjects stand quietly (arms folded) on the ground or on a compliant surface while sway is measured using small sensors placed on the body (inertial measurement units). The sensors measure amount of sway in degrees and the duration the subject stands is measured for up to 30 seconds. Sway scores range 0 to 20 degrees of motion side to side and fore-aft. Lower scores correlate with a better balance.
Measured: Every other week, up to 6 months
Change in the tandem walk test assessed by number of steps taken
Ability to walk heel to toe for a distance of 10 steps.
Measured: Every other week, up to 6 months
Change in the time to complete the Timed Up and Go (TUG) Ipsi Turn.
Subjects total time (in seconds) is recorded to stand from seated position, walk 3 meters, turn around 180-degrees and return to sit.
Measured: Every other week, up to 6 months
Change in the time to complete the Timed Up and Go (TUG) Contra Turn.
Subjects total time (in seconds) is recorded to stand from seated position, walk 3 meters, turn around 180-degrees and return to sit.
Measured: Every other week, up to 6 months
Change in Fogginess (mental) during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test that includes stepping while viewing a virtual scenario of a patrol task. Subjects step on/off a 6-inch step while being asked to identify objects in the virtual scene. The fogginess is rated on a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Measured: Every other week, up to 6 months
Change in Dizziness during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test that includes stepping while viewing a virtual scenario of a patrol task. Subjects step on/off a 6-inch step while being asked to identify objects in the virtual scene. The dizziness is on a visual analog scale from from 0 (no symptoms) -10 (worse symptoms).
Measured: Every other week, up to 6 months
Change in Headache during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test that includes stepping while viewing a virtual scenario of a patrol task. Subjects step on/off a 6-inch step while being asked to identify objects in the virtual scene. The headache is rated on a a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Measured: Every other week, up to 6 months
Change in Nausea during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test that includes stepping while viewing a virtual scenario of a patrol task. Subjects step on/off a 6-inch step while being asked to identify objects in the virtual scene. The nausea is rated on a a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Measured: Every other week, up to 6 months
Change in visual acuity during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involving the use of virtual reality goggles and viewing a scenario that mimic a patrolling scenario. Subjects step on/off a 6-inch step while being asked to identify objects in the scene. A subjective rating of visual acuity using a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Measured: Every other week, up to 6 months
Change in Mean Reaction Time during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The reaction time (in milliseconds) to respond to 11 auditory cues embedded in the virtual scene is measured.
Measured: Every other week, up to 6 months
Change in 5 min heart rate during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The heart rate at 5 minute is measured in beats per minute.
Measured: Every other week, up to 6 months
Pre heart rate during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The initial heart rate is measured in beats per minute.
Measured: Every other week, up to 6 months
Post (video) heart rate during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The post video completion heart rate is measured in beats per minute.
Measured: Every other week, up to 6 months
Final heart rate during the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. The 3 min post video completion heart rate is measured in beats per minute.
Measured: Every other week, up to 6 months
Pre Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. Rate of Perceived Exertion (RPE) is measured on a scale from 6 (rest) - 20 (maximal exertion) scale.
Measured: Every other week, up to 6 months
Post (video) Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. Post RPE is measured at the end of the video using the 6 (rest) - 20 (maximal exertion) scale.
Measured: Every other week, up to 6 months
5 min Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
This is a 12-minute test involve stepping on/off a 6-in step while viewing a virtual video patrol scenario. RPE is measured at the 5th minute from starting the video using the 6 (rest) - 20 (maximal exertion) scale.
Measured: Every other week, up to 6 months
Change in the Functional Gait Assessment (FGA)
The FGA is a 10-item behavioral test assessing risk for fall. Each items is scored from 0 (severe) to 3 (normal) impairment. Scores range from 0 - 30 with scores compared against normative data.
Measured: Every other week, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start11 Oct 2021
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will randomize placement in two groups of gaze stability exercises (IVE or traditional VPT). Each of the three Aims will recruit active duty service members with mTBI and dizziness from the Intrepid Spirit Center at Fort Belvoir Community Hospital (FBCH) and civilians with unilateral vestibular hypofunction from Johns Hopkins University (JHU). Inclusion criteria for the FBCH site are active duty service member with mTBI and 'vestibular' symptoms (dizziness, oscillopsia, motion sensitivity, imbalance). Inclusion criteria for the JHU site are civilians with unilateral vestibular hypofunction.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Fort Belvoir Community Hospital, Neuroscience Research Australia, Walter Reed National Military Medical Center
- Responsible party
- Sponsor
- Investigators
- Michael C Schubert, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846830
- Sponsor's protocol ID
- IRB00182654
- Other IDs
- CDMRP-PT170081
- Acronym
- INVENT
- Status last verified
- Nov 2025
- First submitted
- 15 Feb 2019
- Last updated
- 12 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will only share de-identified individual participant data (IPD) with researchers on the approved research protocol.
Publications
Todd CJ, Hubner PP, Hubner P, Schubert MC, Migliaccio AA. StableEyes-A Portable Vestibular Rehabilitation Device. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1223-1232. doi: 10.1109/TNSRE.2018.2834964.
PubMed 29877847Migliaccio AA, Schubert MC. Pilot study of a new rehabilitation tool: improved unilateral short-term adaptation of the human angular vestibulo-ocular reflex. Otol Neurotol. 2014 Dec;35(10):e310-6. doi: 10.1097/MAO.0000000000000539.
PubMed 25122595Ervin AM, Schubert MC, Migliaccio AA, Perin J, Coulibaly H, Millar JL, Roberts D, Shelhamer M, Gold D, Beauregard S, Pinto R, Brungart D, Ward BK; INVENT VPT Research Group. Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) Trial: study protocol for a randomized controlled crossover trial. Trials. 2021 Dec 11;22(1):908. doi: 10.1186/s13063-021-05876-4.
PubMed 34895314
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVENT VPT: Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
- ClinicalTrials.gov ID
- NCT03846830
- Acronym / sponsor ID
- INVENT / IRB00182654
- Conditions
- Mild Traumatic Brain Injury, Vestibular Neuropathy
- Keywords
- gaze stability, balance, vestibulo-ocular reflex (VOR) gain, dizzy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Fort Belvoir Community Hospital, Neuroscience Research Australia, Walter Reed National Military Medical Center
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 20 Feb 2019 (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.
The objective for this study is to compare outcome measures from vestibular rehabilitation (VPT) delivered in a traditional method against a new device Incremental Velocity Error (IVE) that improves physiologic performance of the vestibulo-ocular reflex. Participants include active duty service members with mild traumatic brain injury (mTBI) and civilians with peripheral vestibular hypofunction. The investigators will use a clinical trial cross-over design with randomization to either the control (VPT) or experimental (IVE) group and measure vestibulo-ocular reflex function as well as subjective and functional outcomes in order to investigate the best means to improve delivery of vestibular rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The investigators will randomize placement in two groups of gaze stability exercises (IVE or traditional VPT). Each of the three Aims will recruit active duty service members with mTBI and dizziness from the Intrepid Spirit Center at Fort Belvoir Community Hospital (FBCH) and civilians with unilateral vestibular hypofunction from Johns Hopkins University (JHU). Inclusion criteria for the FBCH site are active duty service member with mTBI and 'vestibular' symptoms (dizziness, oscillopsia, motion sensitivity, imbalance). Inclusion criteria for the JHU site are civilians with unilateral vestibular hypofunction.
| Arm | Type | Receives |
|---|---|---|
| IVE/VPT 6 week Crossover | Active comparator | Device: Incremental Velocity Error (IVE), Behavioral: Traditional Vestibular Rehabilitation (VPT)Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 5 weeks, 6 weeks washout, and then crossover into the other group for a final 5 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout each of the 5 weeks epochs of training. |
| IVE/VPT 3 week Crossover | Experimental | Device: Incremental Velocity Error (IVE), Behavioral: Traditional Vestibular Rehabilitation (VPT)Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training will not start until the washout period. |
| IVE/VPT 3 week crossover | Active comparator | Device: Incremental Velocity Error (IVE), Behavioral: Traditional Vestibular Rehabilitation (VPT)Subjects will randomly be placed in one of two groups (IVE or VPT) involving every other day exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout the 3 weeks of exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Greater than or equal to 18 years old
- Service members with mTBI and civilian patients with vestibular hypofunction, both of which reports vestibular symptoms (i.e. dizziness, imbalance).
Key exclusion criteria (3 listed)
- Any subjects with a self-reported history of significant ophthalmic, neuromuscular, cardiovascular (except hypertension), renal/electrolyte and psychiatric disorders
- Those with uncontrolled severe hypertension (systolic BP of >200 mm Hg and/or a diastolic BP of > 110 mmHg at rest)
- Those with a recent history of alcohol and/or drug abuse within the past 6 months
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 |
|---|---|---|
| Incremental Velocity Error (IVE)A lightweight headband has electronics attached that detect head velocity and move a laser target at a fraction of the head velocity. | Device | IVE/VPT 3 week Crossover, IVE/VPT 3 week crossover, IVE/VPT 6 week Crossover |
| Traditional Vestibular Rehabilitation (VPT)Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance. | Behavioural | IVE/VPT 3 week Crossover, IVE/VPT 3 week crossover, IVE/VPT 6 week Crossover |
Primary outcome
Change in vestibulo-ocular reflex (VOR) Gain
Time frame: Weekly, up to 6 months
A ratio of eye/head velocity measured using a small video camera attached to a lightweight headband. This is an off-the-shelf device commonly used in clinic. Scores typically vary between 0 and 1.2 and normal ranges are between 0.8 and 1.2.
28 secondary outcomes
Baseline vestibular function assessed with Videonystagmography/Electronystagmography (VNG/ENG)
Time frame: At first visit, up to 30 minutes.
Baseline oculomotor function assessed with Videonystagmography/Electronystagmography (VNG/ENG)
Time frame: At first visit, up to 30 minutes.
Baseline vestibular function assessed with Vestibular Evoked Myogenic Potential (VEMP)
Time frame: At first visit, up to 20 minutes.
Baseline vestibular function assessed with Rotary Chair
Time frame: At first visit, up to 40 minutes.
Change in Dizziness Handicap Inventory
Time frame: Every other week, up to 6 months
Change in Activity Specific Balance Confidence scale (ABC)
Time frame: Every other week, up to 6 months
Change in Neurobehavioral Symptom Inventory (NSI)
Time frame: Every other week, up to 6 months
Change in Patient Global Impression of Change (PGIC)
Time frame: Every other week, up to 6 months
Change in Dynamic Visual Acuity (DVA)
Time frame: Every other week, up to 6 months
Change in Time ( in seconds) Standing during the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Time frame: Every other week, up to 6 months
Change in Area (in degrees) of Sway during the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Time frame: Every other week, up to 6 months
Change in the tandem walk test assessed by number of steps taken
Time frame: Every other week, up to 6 months
Change in the time to complete the Timed Up and Go (TUG) Ipsi Turn.
Time frame: Every other week, up to 6 months
Change in the time to complete the Timed Up and Go (TUG) Contra Turn.
Time frame: Every other week, up to 6 months
Change in Fogginess (mental) during the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
Change in Dizziness during the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
Change in Headache during the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
Change in Nausea during the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
Change in visual acuity during the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
Change in Mean Reaction Time during the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
Change in 5 min heart rate during the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
Pre heart rate during the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
Post (video) heart rate during the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
Final heart rate during the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
Pre Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
Post (video) Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
5 min Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
Time frame: Every other week, up to 6 months
Change in the Functional Gait Assessment (FGA)
Time frame: Every other week, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Background: PubMed 29877847Todd CJ, Hubner PP, Hubner P, Schubert MC, Migliaccio AA. StableEyes-A Portable Vestibular Rehabilitation Device. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1223-1232. doi: 10.1109/TNSRE.2018.2834964.
- Background: PubMed 25122595Migliaccio AA, Schubert MC. Pilot study of a new rehabilitation tool: improved unilateral short-term adaptation of the human angular vestibulo-ocular reflex. Otol Neurotol. 2014 Dec;35(10):e310-6. doi: 10.1097/MAO.0000000000000539.
- Derived from this study: PubMed 34895314Ervin AM, Schubert MC, Migliaccio AA, Perin J, Coulibaly H, Millar JL, Roberts D, Shelhamer M, Gold D, Beauregard S, Pinto R, Brungart D, Ward BK; INVENT VPT Research Group. Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT VPT) Trial: study protocol for a randomized controlled crossover trial. Trials. 2021 Dec 11;22(1):908. doi: 10.1186/s13063-021-05876-4.
- Patent for the device being studiedLink provided by the sponsor.
- Individual participant dataSharing planned: No. We will only share de-identified individual participant data (IPD) with researchers on the approved research protocol.
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Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
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 C Schubert, PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incremental Velocity Error (IVE) and Traditional Vestibular Rehabilitation (VPT) in people with Mild Traumatic Brain Injury and Vestibular Neuropathy, run by Johns Hopkins University at 2 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 2 inclusion and 3 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 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in vestibulo-ocular reflex (VOR) Gain (time frame: Weekly, up to 6 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 NCT03846830, which also lists 3 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 12 Nov 2025.