Vestibular Disease Clinical Trial
Official title:
A Clinical Study to Evaluate the Safety and Efficacy of the BrainPort™ Balance Device When Used to Improve Postural Control in Subjects With Bilateral Vestibular Disorders
The purpose of this study is to determine whether the BrainPort™ balance device is safe and effective in the treatment of balance disorders in patients with Bilateral Vestibular Dysfunction.
People with Bilateral Vestibular Dysfunction (BVD) often experience disabling symptoms,
greatly affecting their quality of life and ability to work. Current vestibular treatment
does not always allow these patients to fully recover. Many patients either do not improve
or reach a plateau with conventional vestibular rehabilitation, and still have difficulty
with daily function. The BrainPort™ balance device is intended to provide information about
head position to the brain through electrotactile stimulation of the tongue to improve
balance in subjects with vestibular disorders.
This study is a prospective, multi-center, randomized double-blinded study comparing the
postural stability of BVD subjects using the BrainPort™ balance device to postural stability
of control subjects using a sham device and respective baseline measures for each group. The
primary objective of this study is to determine whether electrotactile stimulation of the
tongue, using the BrainPort™ balance device, can improve postural stability, as measured by
improvement in performance of the composite Computerized Dynamic Posturography using the
NeuroCom® Sensory Organization Test in subjects with chronic bilateral vestibular
dysfunction (BVD). The secondary objectives are to evaluate improvement in quality of life,
as measured by the Activities Specific Balance Confidence (ABC) Scale, Dizziness Handicap
Inventory (DHI), and the Dynamic Gait Index (DGI), and to demonstrate a decreased number of
falls on the NeuroCom® Sensory Organization Test. In addition, we will monitor the number of
falls that occur during subjects' normal activities of daily living. The long-term objective
is to evaluate the safety and efficacy when the device is used over a one-year period.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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