Clinical trial NCT03846830: Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
Official title: INVENT VPT: Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Vestibular Neuropathy
Keywords: gaze stability
balance
vestibulo-ocular reflex (VOR) gain
dizzy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Fort Belvoir Community Hospital
name: Neuroscience Research Australia
name: Walter Reed National Military Medical Center
First posted: 2019-02-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in vestibulo-ocular reflex (VOR) Gain
timeFrame: Weekly, up to 6 months
Secondary outcomes:
measure: Baseline vestibular function assessed with Videonystagmography/Electronystagmography (VNG/ENG)
timeFrame: At first visit, up to 30 minutes.
measure: Baseline oculomotor function assessed with Videonystagmography/Electronystagmography (VNG/ENG)
timeFrame: At first visit, up to 30 minutes.
measure: Baseline vestibular function assessed with Vestibular Evoked Myogenic Potential (VEMP)
timeFrame: At first visit, up to 20 minutes.
measure: Baseline vestibular function assessed with Rotary Chair
timeFrame: At first visit, up to 40 minutes.
measure: Change in Dizziness Handicap Inventory
timeFrame: Every other week, up to 6 months
measure: Change in Activity Specific Balance Confidence scale (ABC)
timeFrame: Every other week, up to 6 months
measure: Change in Neurobehavioral Symptom Inventory (NSI)
timeFrame: Every other week, up to 6 months
measure: Change in Patient Global Impression of Change (PGIC)
timeFrame: Every other week, up to 6 months
measure: Change in Dynamic Visual Acuity (DVA)
timeFrame: Every other week, up to 6 months
measure: Change in Time ( in seconds) Standing during the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
timeFrame: Every other week, up to 6 months
measure: Change in Area (in degrees) of Sway during the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
timeFrame: Every other week, up to 6 months
measure: Change in the tandem walk test assessed by number of steps taken
timeFrame: Every other week, up to 6 months
measure: Change in the time to complete the Timed Up and Go (TUG) Ipsi Turn.
timeFrame: Every other week, up to 6 months
measure: Change in the time to complete the Timed Up and Go (TUG) Contra Turn.
timeFrame: Every other week, up to 6 months
measure: Change in Fogginess (mental) during the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: Change in Dizziness during the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: Change in Headache during the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: Change in Nausea during the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: Change in visual acuity during the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: Change in Mean Reaction Time during the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: Change in 5 min heart rate during the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: Pre heart rate during the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: Post (video) heart rate during the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: Final heart rate during the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: Pre Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: Post (video) Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: 5 min Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)
timeFrame: Every other week, up to 6 months
measure: Change in the Functional Gait Assessment (FGA)
timeFrame: Every other week, up to 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Fort Belvoir
country: United States
facility: Fort Belvoir CH
state: Virginia
Study officials:
affiliation: Johns Hopkins University
name: Michael C Schubert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.