Safety and Efficacy of the BrainPort™ Balance Device to Improve Balance in Bilateral Vestibular Hypofunction
NCT ID: NCT00254228
Last Updated: 2008-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
60 participants
INTERVENTIONAL
2005-11-30
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Electrotactile sensory substitution
Eligibility Criteria
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Inclusion Criteria
* No greater than 2 successful attempts out of 6 on the NeuroCom Equitest Sensory Organization Tests 5 and 6.
* Failure on the Rotary Chair Vestibulo-ocular Reflex (VOR) Test as evidenced by a gain of less than or equal to -2 standard deviations at frequencies of .025, and .05 Hz.
* Normal corrected vision (20/40 or better).
* Able to read and understand the informed consent form, and willing to sign the informed consent form.
* Willing to complete all follow-up evaluations required by the study protocol.
* Able to stand for a period of 20 minutes in a stationary position with weight evenly distributed without moderate pain, muscle cramping or numbness in the lower extremities.
Exclusion Criteria
* Current oral health problems as determined by health questionnaire and an examination of the oral cavity.
* Cigarette smokers and those who use chewing tobacco.
* Currently taking either benzodiazepine or barbiturate medication.
* Any medical condition as determined by the health questionnaire that would interfere with performance on the postural stability evaluation tests.
* Known neuropathies of tongue or skin tactile system.
* Peripheral neuropathies of the lower extremities.
* Prior exposure to BrainPort™ balance device (does not apply to control group subjects who cross over).
* Subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.
* Subjects who have undergone middle ear or other surgery with sacrifice or damage to the chorda tympani, lingual, or hypoglossal nerve.
* Subjects who have an implanted device such as a pacemaker or defibrillator.
* If the subject is female, she is pregnant.
* If the subject is unwilling to discontinue medications for dizziness or imbalance 48 hours prior to beginning the study.
18 Years
85 Years
ALL
No
Sponsors
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Wicab
INDUSTRY
Principal Investigators
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Yuri P Danilov, PhD
Role: STUDY_DIRECTOR
Wicab
Locations
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Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Wisconsin, Madison
Madison, Wisconsin, United States
Medway Balance Centre
Kent, , United Kingdom
Countries
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References
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Bach-y-Rita P, W Kercel S. Sensory substitution and the human-machine interface. Trends Cogn Sci. 2003 Dec;7(12):541-6. doi: 10.1016/j.tics.2003.10.013.
Tyler M, Danilov Y, Bach-Y-Rita P. Closing an open-loop control system: vestibular substitution through the tongue. J Integr Neurosci. 2003 Dec;2(2):159-64. doi: 10.1142/s0219635203000263.
Bach-y-rita P, Danilov YP, Tyler ME, Grimm RF. Late Human Brain Plasticity: Vestibular Substitution with a Tongue BrainPort Human-Machine Interface. Journal Intellectica, 2005 (in press).
Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.
Related Links
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Related Info
Other Identifiers
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WCB1-001
Identifier Type: -
Identifier Source: org_study_id