NCT03846830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
2.6 years until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

3.5 years

First QC Date

February 15, 2019

Last Update Submit

November 10, 2025

Conditions

Mild Traumatic Brain InjuryVestibular Neuropathy

Keywords

gaze stabilitybalancevestibulo-ocular reflex (VOR) gaindizzy

Outcome Measures

Primary Outcomes (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.

    Weekly, up to 6 months

Secondary Outcomes (28)

  • Baseline vestibular function assessed with Videonystagmography/Electronystagmography (VNG/ENG)

    At first visit, up to 30 minutes.

  • Baseline oculomotor function assessed with Videonystagmography/Electronystagmography (VNG/ENG)

    At first visit, up to 30 minutes.

  • Baseline vestibular function assessed with Vestibular Evoked Myogenic Potential (VEMP)

    At first visit, up to 20 minutes.

  • Baseline vestibular function assessed with Rotary Chair

    At first visit, up to 40 minutes.

  • Change in Dizziness Handicap Inventory

    Every other week, up to 6 months

  • +23 more secondary outcomes

Study Arms (3)

IVE/VPT 6 week Crossover

ACTIVE COMPARATOR

Subjects 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.

Device: Incremental Velocity Error (IVE)Behavioral: Traditional Vestibular Rehabilitation (VPT)

IVE/VPT 3 week Crossover

EXPERIMENTAL

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)Behavioral: Traditional Vestibular Rehabilitation (VPT)

IVE/VPT 3 week crossover

ACTIVE COMPARATOR

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)Behavioral: Traditional Vestibular Rehabilitation (VPT)

Interventions

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.

IVE/VPT 3 week CrossoverIVE/VPT 3 week crossoverIVE/VPT 6 week Crossover
Traditional Vestibular Rehabilitation (VPT)BEHAVIORAL

Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance.

IVE/VPT 3 week CrossoverIVE/VPT 3 week crossoverIVE/VPT 6 week Crossover

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Fort Belvoir CH

Fort Belvoir, Virginia, 22060, United States

Location

Related Publications (3)

  • 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.

    PMID: 29877847BACKGROUND

  • 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.

    PMID: 25122595BACKGROUND

  • 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.

    PMID: 34895314DERIVED

Related Links

MeSH Terms

Conditions

Brain ConcussionVestibular NeuronitisDizziness

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesCranial Nerve DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael C Schubert, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 20, 2019

Study Start

October 11, 2021

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

We will only share de-identified individual participant data (IPD) with researchers on the approved research protocol.

Locations

US(2)