Vestibular DiseaseNCT00254228
Safety and Efficacy of the BrainPort™ Balance Device to Improve Balance in Bilateral Vestibular Hypofunction
A study testing Electrotactile sensory substitution in people with Vestibular Disease, run by Wicab at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vestibular Disease
- What is being tested?
- Electrotactile sensory substitution
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Nov 2005to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Mayo Clinic
Jacksonville, Florida, 32224
University of Wisconsin, Madison
Madison, Wisconsin, 53792
Mayo Clinic
Rochester, Minnesota, 55905
Washington University
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Vestibular Disease
- Being tested
- Electrotactile sensory substitution
- Keywords
- Balance, Vestibular, Electrotactile, BrainPort, Sensory substitution, Tongue
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrotactile sensory substitutionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized Dynamic Posturography using the NeuroCom Sensory Organization Test (SOT) composite score, taken at baseline, 1 week, 8 weeks and 12 months.
Secondary outcomes (6)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startNov 2005
- Study completionDec 2007
Why it stopped: Terminated due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vestibular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Wicab
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yuri P Danilov, PhD, Study director, Wicab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254228
- Sponsor's protocol ID
- WCB1-001
- Status last verified
- Oct 2008
- First submitted
- 10 Nov 2005
- Last updated
- 9 Oct 2008
- Results posted
- No
Publications
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.
PubMed 14643370Tyler 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.
PubMed 15011268Bach-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.
PubMed 15988797
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00254228
- Acronym / sponsor ID
- WCB1-001
- Conditions
- Vestibular Disease
- Keywords
- Balance, Vestibular, Electrotactile, BrainPort, Sensory substitution, Tongue
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow recruitment
- Enrolment
- 60 participants
- Lead sponsor
- WicabIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Dec 2007
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrotactile sensory substitution | Device | – |
Primary outcome
Computerized Dynamic Posturography using the NeuroCom Sensory Organization Test (SOT) composite score, taken at baseline, 1 week, 8 weeks and 12 months.
6 secondary outcomes
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.
Results and safety
The study was stopped early (reason given: Terminated due to slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2008.
- Background: PubMed 14643370Bach-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.
- Background: PubMed 15011268Tyler 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.
- BackgroundBach-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).
- Background: PubMed 15988797Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.
- Related InfoLink provided by the sponsor.
Related trials for Vestibular Disease
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced
Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Recruiting
Human Visual and Vestibular Motion Perception Study
Vestibular Disease
Not yet recruitingObservational study
Prevalence and Diagnosis of Persistent Postural-perceptual Dizziness
Persistent Postural-perceptual Dizziness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuri P Danilov, PhD study director
Wicab
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrotactile sensory substitution in people with Vestibular Disease, run by Wicab at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerized Dynamic Posturography using the NeuroCom Sensory Organization Test (SOT) composite score, taken at baseline, 1 week, 8 weeks and 12 months.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00254228, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2008; AzTrials last refreshed its copy on 8 Nov 2026.