Safety and Efficacy of the BrainPort™ Balance Device to Improve Balance in Bilateral Vestibular Hypofunction
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- Computerized Dynamic Posturography using the NeuroCom Sensory Organization Test (SOT) composite score, taken at baseline, 1 week, 8 weeks and 12 months.
- Activities-specific Balance Confidence Scale (ABC)
- Dizziness Handicap Inventory (DHI)
- Dynamic Gait Index (DGI)
- Number of falls on the NeuroCom SOT
- Functional Objective Tests i.e. standing with eyes closed, on one leg, etc.
- All tests taken at baseline, 1 week, 8 weeks and 12 months.
|Study Start Date:||November 2005|
|Estimated Study Completion Date:||December 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254228
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|United States, Wisconsin|
|University of Wisconsin, Madison|
|Madison, Wisconsin, United States, 53792|
|Medway Balance Centre|
|Kent, United Kingdom, ME7 5NY|
|Study Director:||Yuri P Danilov, PhD||Wicab|