Incremental Velocity Error (IVE)
DeviceA lightweight headband has electronics attached that detect head velocity and move a laser target at a fraction of the head velocity.
NCT Number: NCT03846830
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Johns Hopkins University, Baltimore, Maryland, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A lightweight headband has electronics attached that detect head velocity and move a laser target at a fraction of the head velocity.
Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Every other week, up to 6 months
Ability to walk heel to toe for a distance of 10 steps.
Time frame: Every other week, up to 6 months
Subjects total time (in seconds) is recorded to stand from seated position, walk 3 meters, turn around 180-degrees and return to sit.
Time frame: Every other week, up to 6 months
Subjects total time (in seconds) is recorded to stand from seated position, walk 3 meters, turn around 180-degrees and return to sit.
Time frame: Every other week, up to 6 months
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).
Time frame: Every other week, up to 6 months
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).
Time frame: Every other week, up to 6 months
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).
Time frame: Every other week, up to 6 months
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).
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 using a visual analog scale from 0 (no symptoms) -10 (worse symptoms).
Time frame: Every other week, up to 6 months
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.
Time frame: Every other week, up to 6 months
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.
Time frame: Every other week, up to 6 months
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.
Time frame: Every other week, up to 6 months
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.
Time frame: Every other week, up to 6 months
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.
Time frame: Every other week, up to 6 months
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.
Time frame: Every other week, up to 6 months
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.
Time frame: Every other week, up to 6 months
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.
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.
Johns Hopkins University
Other
INVENT VPT: Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
Acronym: INVENT
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