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Safety and Efficacy of the BrainPort™ Balance Device to Improve Balance in Bilateral Vestibular Hypofunction

Primary Purpose

Vestibular Disease

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Electrotactile sensory substitution
Sponsored by
Wicab
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Disease focused on measuring Balance, Vestibular, Electrotactile, BrainPort, Sensory substitution, Tongue

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Documented history of acquired bilateral vestibular dysfunction for a duration of at least one year which has been unsuccessfully treated or reached a plateau with conventional vestibular rehabilitation. 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: Neurological disorders other than bilateral vestibular disorder, as determined by medical history and neurological screening procedure. 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.

Sites / Locations

  • Mayo Clinic
  • Mayo Clinic
  • Washington University
  • University of Wisconsin, Madison
  • Medway Balance Centre

Outcomes

Primary Outcome Measures

Computerized Dynamic Posturography using the NeuroCom Sensory Organization Test (SOT) composite score, taken at baseline, 1 week, 8 weeks and 12 months.

Secondary Outcome Measures

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.

Full Information

First Posted
November 10, 2005
Last Updated
October 8, 2008
Sponsor
Wicab
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1. Study Identification

Unique Protocol Identification Number
NCT00254228
Brief Title
Safety and Efficacy of the BrainPort™ Balance Device to Improve Balance in Bilateral Vestibular Hypofunction
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to slow recruitment
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Wicab

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disease
Keywords
Balance, Vestibular, Electrotactile, BrainPort, Sensory substitution, Tongue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Electrotactile sensory substitution
Primary Outcome Measure Information:
Title
Computerized Dynamic Posturography using the NeuroCom Sensory Organization Test (SOT) composite score, taken at baseline, 1 week, 8 weeks and 12 months.
Secondary Outcome Measure Information:
Title
Activities-specific Balance Confidence Scale (ABC)
Title
Dizziness Handicap Inventory (DHI)
Title
Dynamic Gait Index (DGI)
Title
Number of falls on the NeuroCom SOT
Title
Functional Objective Tests i.e. standing with eyes closed, on one leg, etc.
Title
All tests taken at baseline, 1 week, 8 weeks and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented history of acquired bilateral vestibular dysfunction for a duration of at least one year which has been unsuccessfully treated or reached a plateau with conventional vestibular rehabilitation. 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: Neurological disorders other than bilateral vestibular disorder, as determined by medical history and neurological screening procedure. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuri P Danilov, PhD
Organizational Affiliation
Wicab
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Wisconsin, Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medway Balance Centre
City
Kent
ZIP/Postal Code
ME7 5NY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
14643370
Citation
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.
Results Reference
background
PubMed Identifier
15011268
Citation
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.
Results Reference
background
Citation
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).
Results Reference
background
PubMed Identifier
15988797
Citation
Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.
Results Reference
background
Links:
URL
http://www.wicab.com
Description
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Safety and Efficacy of the BrainPort™ Balance Device to Improve Balance in Bilateral Vestibular Hypofunction

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