Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation

Mild Traumatic Brain Injury Clinical Trial

— INVENT  

Official title:

INVENT VPT: Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03846830
• Other study ID #: IRB00182654
• Secondary ID: CDMRP-PT170081
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: Johns Hopkins University
• Contact: Jennifer Millar, MSPT
• Phone: 410-955-0016
• Email: jmillar1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Vestibular Neuronitis
• Vestibular Neuropathy

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Fort Belvoir Community Hospital, Neuroscience Research Australia, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Weekly, up to 6 months
Secondary	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.	At first visit, up to 30 minutes.
Secondary	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.	At first visit, up to 30 minutes.
Secondary	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.	At first visit, up to 20 minutes.
Secondary	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.	At first visit, up to 40 minutes.
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	Change in the tandem walk test assessed by number of steps taken	Ability to walk heel to toe for a distance of 10 steps.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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).	Every other week, up to 6 months
Secondary	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).	Every other week, up to 6 months
Secondary	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).	Every other week, up to 6 months
Secondary	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).	Every other week, up to 6 months
Secondary	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).	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months
Secondary	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.	Every other week, up to 6 months

External Links

•   Patent for the device being studied