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

Johns Hopkins University

Status: Completed

Conditions: Vestibular Neuropathy; Mild Traumatic Brain Injury

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03846830

CDMRP-PT170081 (Other Grant/Funding Number)

IRB00182654

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups

IVE/VPT 6 week Crossover

Active Comparator group

Description:

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.

Treatment:

Device: Incremental Velocity Error (IVE)

Behavioral: Traditional Vestibular Rehabilitation (VPT)

IVE/VPT 3 week Crossover

Experimental group

Description:

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.

Treatment:

Device: Incremental Velocity Error (IVE)

Behavioral: Traditional Vestibular Rehabilitation (VPT)

IVE/VPT 3 week crossover

Active Comparator group

Description:

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.

Treatment:

Device: Incremental Velocity Error (IVE)

Behavioral: Traditional Vestibular Rehabilitation (VPT)