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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Incremental Velocity Error (IVE) and Traditional Vestibular Rehabilitation (VPT)
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

Other trials in United States

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.

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 groups in NCT03846830
Study groupRoleWhat they receive
IVE/VPT 6 week CrossoverActive comparatorSubjects 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 CrossoverExperimentalSubjects 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 crossoverActive comparatorSubjects 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.

  1. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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.

  1. First posted20 Feb 2019
  2. Study start11 Oct 2021
  3. Primary completion1 Apr 2025
  4. Study completion1 Apr 2025

Resources

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)
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 29877847
  • Migliaccio 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 25122595
  • Ervin 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

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.

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