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Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation (INVENT)

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ClinicalTrials.gov Identifier: NCT03846830
Recruitment Status : Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborators:
Fort Belvoir Community Hospital
Neuroscience Research Australia
Walter Reed National Military Medical Center
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Vestibular Neuropathy Device: Incremental Velocity Error (IVE) Behavioral: Traditional Vestibular Rehabilitation (VPT) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: INVENT VPT: Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: IVE/VPT 6 week Crossover
Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 6 weeks, 6 weeks washout, and then crossover into the other group for a final 6 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 6 weeks of exercise.
Device: 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.

Behavioral: Traditional Vestibular Rehabilitation (VPT)
Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance.

Experimental: IVE/VPT 3 week Crossover
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.
Device: 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.

Behavioral: Traditional Vestibular Rehabilitation (VPT)
Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance.

Active Comparator: IVE/VPT 3 week crossover
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.
Device: 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.

Behavioral: Traditional Vestibular Rehabilitation (VPT)
Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance.




Primary Outcome Measures :
  1. 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. We expect to see this improve with rehabilitation.


Secondary Outcome Measures :
  1. Baseline vestibular function assessed with Videonystagmography/Electronystagmography (VNG/ENG) [ Time Frame: At first visit, up to 30 minutes. ]
    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.

  2. Baseline oculomotor function assessed with Videonystagmography/Electronystagmography (VNG/ENG) [ Time Frame: At first visit, up to 30 minutes. ]

    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.


  3. Baseline vestibular function assessed with Vestibular Evoked Myogenic Potential (VEMP) [ Time Frame: At first visit, up to 20 minutes. ]
    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.

  4. Baseline vestibular function assessed with Rotary Chair [ Time Frame: At first visit, up to 40 minutes. ]
    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.

  5. Change in Dizziness Handicap Inventory [ Time Frame: Every other week, up to 6 months ]
    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.

  6. Change in Activity Specific Balance Confidence scale (ABC) [ Time Frame: Every other week, up to 6 months ]
    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.

  7. Change in Neurobehavioral Symptom Inventory (NSI) [ Time Frame: Every other week, up to 6 months ]
    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.

  8. Change in Patient Global Impression of Change (PGIC) [ Time Frame: Every other week, up to 6 months ]
    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.

  9. Change in Dynamic Visual Acuity (DVA) [ Time Frame: Every other week, up to 6 months ]
    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.

  10. 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 ]
    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.

  11. 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 ]
    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.

  12. Change in the tandem walk test assessed by number of steps taken [ Time Frame: Every other week, up to 6 months ]
    Ability to walk heel to toe for a distance of 10 steps.

  13. Change in Dynamic Gait Index (DGI) [ Time Frame: Every other week, up to 6 months ]
    An 8-item scale that determines fall risk in older adults. This is a behavioral test that asks subjects to walk and perform different functional tasks while being rated for their balance. The items are scored from 0 (unable to complete) to 3 (normal) with scores ranging from 0 - 24. Scores greater than 19 indicate normal fall risk.

  14. Change in number of steps to complete a turn during the instrumented stand and walk (ISAW) [ Time Frame: Every other week, up to 6 months ]
    Subjects wear inertial measurement units (IMU) that provide velocity and acceleration data of the body as subjects stand for 30-second, walk 7-meter and then turn around 180-degrees. The number of steps taken to complete a turn will be counted.

  15. Change in body velocity turning 180 degrees during the instrumented stand and walk (ISAW) [ Time Frame: Every other week, up to 6 months ]
    Subjects wear inertial measurement units (IMU) that provide velocity and acceleration data of the body as subjects stand for 30-second, walk 7-meter and then turn around 180-degrees. The velocity of the body (in deg/sec) during turning 180 degrees is collected from the IMU.

  16. Change in duration of turn during the instrumented stand and walk (ISAW) [ Time Frame: Every other week, up to 6 months ]
    Subjects wear inertial measurement units (IMU) that provide velocity and acceleration data of the body as subjects stand for 30-second, walk 7-meter and then turn around 180-degrees. The duration in seconds to turn 180 degrees is collected from the IMU.

  17. Change in the time to complete the instrumented stand and walk (ISAW) [ Time Frame: Every other week, up to 6 months ]
    Subjects total time (in seconds) is recorded to stand for 30-second, walk 7-meter and then turn around 180-degrees.

  18. Change in Exertion during the Patrol Exertion Multitask Test (PEMT) [ Time Frame: Every other week, up to 6 months ]
    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. The rate of perceived exertion, a subjective rating of exertion (6-20 with higher scores indicating higher exertion) is assessed.

  19. Change in visual acuity during the Patrol Exertion Multitask Test (PEMT) [ Time Frame: Every other week, up to 6 months ]
    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 (0-10, where 0 indicates completely clear) is assessed.

  20. Change in Reaction Time during the Patrol Exertion Multitask Test (PEMT) [ Time Frame: Every other week, up to 6 months ]
    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-in step while being asked to identify objects in the scene. The reaction time (in milliseconds) to respond to identifying objects in the virtual scene is measured.

  21. Change in the Functional Gait Assessment (FGA) [ Time Frame: Every other week, up to 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846830


Contacts
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Contact: Jennifer Millar, MSPT 410-955-0016 jmillar1@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Fort Belvoir Community Hospital
Neuroscience Research Australia
Walter Reed National Military Medical Center
Investigators
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Principal Investigator: Michael C Schubert, PhD Johns Hopkins University

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03846830     History of Changes
Other Study ID Numbers: IRB00182654
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will only share de-identified individual participant data (IPD) with researchers on the approved research protocol.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
gaze stability
balance
vestibulo-ocular reflex (VOR) gain
dizzy

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating
Vestibular Neuronitis
Central Nervous System Diseases
Nervous System Diseases
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Cranial Nerve Diseases