Vestibular DiseasesNCT00768378
Safety and Efficacy Study of BrainPort® Balance Device in Peripheral Vestibular Dysfunction.
A study testing Training with the BrainPort balance device in people with Vestibular Diseases and Gait Disorders, run by Wicab at 17 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of the BrainPort balance device in improving balance and gait as measured by clinically accepted standardized balance assessments in subjects with peripheral vestibular dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Vestibular Diseases, Gait Disorders
- What is being tested?
- Training with the BrainPort balance device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 17 sitesUnited States
- Study dates
- Jul 2008to Mar 2010
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of peripheral vestibular dysfunction by the following (within 12 months of study enrollment):
- Bilateral Vestibular Hypofunction (BVH)-Sinusoidal rotary chair results at least 2 SD below normal across the frequency range of 0.01 to 0.32 Hz, and at least 60 deg/s peak velocity.
- Unilateral Vestibular Hypofunction (UVH)-Bithermal caloric test results of > 25% unilateral weakness.
- Minimum post 3 months diagnosis with residual balance problems.
- Previously treated with conventional physical therapy, and discharged and/or reached a plateau.
- Functional Ability:
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- Able to ambulate independently or with an assistive device for 20 feet.
- Ability to stand independently for 2 minutes with no or minimal upper extremity support.
- Dynamic Gait Index ≤ 19/24.
- Able to read and sign the informed consent form.
- Fluent in English.
- Willing and able to complete all testing, training, and follow-up evaluations required by the study protocol.
Who cannot join
- Current oral health problems as determined by health questionnaire and an examination of the oral cavity.
- Any medical condition that would interfere with performance on the assessments.
- Known neuropathies of the tongue.
- Prior exposure to BrainPort balance device.
- History of seizures or epilepsy.
- If female, pregnant. Subject must deny pregnancy and agree to use appropriate birth control to prevent pregnancy for the duration of the study.
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- People with implanted electrical medical devices (i.e. pacemaker, deep brain stimulator).
- People currently taking any vestibular suppressant medication (i.e. barbiturates, benzodiazepines, betahistines or cortisone).
- People with a previous diagnosis of a central nervous system lesion (e.g. stroke or brain injury).
- Current diagnosis of any of the following:
- Bilateral areflexia (no response to ice water caloric testing bilaterally)
- Progressive neurological disease (such as Multiple Sclerosis)
- Cervicogenic dizziness
- Pre-syncope/syncope episodes
- Orthostatic hypotension
- Mood Disorders (such as Major Depression and Bipolar Disorder)
- Anxiety disorders
- Hydrops / Ménière's
- Principal Investigator, in his or her medical judgment, does not believe the subject is a good candidate for the trial.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Atlanta Ear Clinic
Atlanta, Georgia, 30342
Medical College of Georgia
Augusta, Georgia, 30912
Elks Hearing & Balance Center
Boise, Idaho, 83702
Lahey Clinic
Burlington, Massachusetts, 01805
South Valley Physical Therapy, PC
Centennial, Colorado, 80111
Houston ENT Clinic
Houston, Texas, 77024
Sensory Therapeutics, Inc.
Jupiter, Florida, 33458
Kansas University Medical Center
Kansas City, Kansas, 66160
England Physical Therapy
Los Angeles, California, 92840
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
New York Eye and Ear Infirmary
New York, New York, 10010
Eastern Virginia Medical School
Norfolk, Virginia, 23507
NBC Rehabilitation
North Miami Beach, Florida, 33160
University of Rochester Medical Center
Rochester, New York, 14642
Pacific Balance and Rehabilitation Clinic
Seattle, Washington, 98109
University of Washington School of Medicine
Seattle, Washington, 98195
Missouri State University
Springfield, Missouri, 65897
About this study
Official title: A Controlled Clinical Study to Evaluate the Safety and Efficacy of the BrainPort® Balance Device When Used to Improve Balance in Subjects With Peripheral Vestibular Dysfunction
The purpose of this study is to assess the safety and efficacy of the BrainPort balance device in improving balance and gait as measured by clinically accepted standardized balance assessments in subjects with peripheral vestibular dysfunction.
Read the detailed description
Peripheral vestibular dysfunction can be caused by inner ear disorders, drug toxicity, neuritis, or a number of other causes. In the absence of a fully functional vestibular system, the brain often requires retraining to correctly utilize visual and proprioceptive cues to maintain postural stability. People with vestibular dysfunction experience multiple problems with posture control and movement, including an unsteady gait and various balance-related difficulties. These effects make it very difficult to walk in the dark or on uneven surfaces without risk of falling. They are typically referred for conventional vestibular therapy. Many patients improve with therapeutic intervention. Some patients reach a plateau and do not return to their previous level of function. The BrainPort balance device transmits head position information via electrotactile stimulation of the tongue. With training, patients learn to use the positional information to correct their balance.
Participants meeting the study criteria will be randomized to the perceived stimulation or subliminal stimulation group. All participants will be given baseline assessments of postural stability, balance, and subjective well being according to standardized tests. After completing the baseline assessments, each participant will be trained in the clinic using a standard training protocol with the BrainPort balance device. Each participant will participate in 6 clinical training sessions, over a period of 3 consecutive days. Upon completion of the clinic training sessions, participants will continue with a 7½ week period of home use. During this period, the participant will train with the device for 20 minutes 2 times per day and the clinicians will contact the participants weekly. At the end of the home training period (8 weeks from the beginning of the study), all participants will again undergo the tests given at baseline.
Following the data analysis, subjects that have completed the 8 week study and were originally assigned to the group with inferior results will be given the opportunity to use the device that showed superior results in the data analysis.
- Conditions
- Vestibular Diseases, Gait Disorders
- Being tested
- Training with the BrainPort balance device
- Keywords
- Physical Therapy (Specialty), Balance dysfunction or disorder, Vestibular, Rehabilitation
- Medical subject headings
- Vestibular Diseases, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with the BrainPort balance deviceDevice
Also called BrainPort Balance Device
Subjects are randomly assigned to one of two groups, the perceived stimulation group or the subliminal stimulation group. Some of these devices provide a stimulus that you can feel. Others provide a stimulus that is below conscious awareness. We are conducting this study to determine if one type of stimulation is more effective than the other.
| Study group | Role | What they receive |
|---|---|---|
| Perceived stimulation | Experimental | When subjects assigned to the perceived stimulation group increase the intensity of the stimulus, they will feel a tingling sensation on the tongue. The tingling will move on the tongue in relation to where the head/body moves. Receives: Device: Training with the BrainPort balance device |
| Subliminal stimulation | Experimental | When subjects assigned to the subliminal stimulation group increase the intensity of the stimulus, the device provides a stimulus that is below their conscious awareness, so they will not be able to perceive it. The stimulus will move on the tongue in relation to where the head/body moves. Receives: Device: Training with the BrainPort balance device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of the BrainPort balance device in improving balance and gait as measured by the Dynamic Gait Index (DGI) in subjects with documented peripheral vestibular dysfunction
Measured: Baseline and 8 weeks (end of study)
Secondary outcomes (3)
To assess the safety of electrical stimulation of the tongue during the use of the BrainPort balance device in subjects with documented peripheral vestibular dysfunction.
Measured: Baseline and ongoing for the duration of the study (8 weeks).
To assess improvement in the Activities-specific Balance Confidence scale (ABC).
Measured: Baseline and 8 weeks (end of study)
To assess improvement in the Dizziness Handicap Inventory (DHI).
Measured: Baseline and 8 weeks (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Vestibular DiseasesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wicab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James O. Phillips, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768378
- Sponsor's protocol ID
- WCB1-005
- Other IDs
- NIH: 2R44 DC004738
- Status last verified
- Jun 2012
- First submitted
- 6 Oct 2008
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Danilov YP, Tyler ME, Skinner KL, Hogle RA, Bach-y-Rita P. Efficacy of electrotactile vestibular substitution in patients with peripheral and central vestibular loss. J Vestib Res. 2007;17(2-3):119-30.
PubMed 18413905Bach-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. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.
PubMed 15988797Danilov YP, Tyler ME, Skinner KL, Bach-y-Rita P. Efficacy of electrotactile vestibular substitution in patients with bilateral vestibular and central balance loss. Conf Proc IEEE Eng Med Biol Soc. 2006;Suppl:6605-9. doi: 10.1109/IEMBS.2006.260899.
PubMed 17959464Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.
PubMed 16385646
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Clinical Study to Evaluate the Safety and Efficacy of the BrainPort® Balance Device When Used to Improve Balance in Subjects With Peripheral Vestibular Dysfunction
- ClinicalTrials.gov ID
- NCT00768378
- Acronym / sponsor ID
- WCB1-005
- Conditions
- Vestibular Diseases, Gait Disorders
- Keywords
- Physical Therapy (Specialty), Balance dysfunction or disorder, Vestibular, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- WicabIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 8 Oct 2008 (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 assess the safety and efficacy of the BrainPort balance device in improving balance and gait as measured by clinically accepted standardized balance assessments in subjects with peripheral vestibular dysfunction.
Detailed description
Peripheral vestibular dysfunction can be caused by inner ear disorders, drug toxicity, neuritis, or a number of other causes. In the absence of a fully functional vestibular system, the brain often requires retraining to correctly utilize visual and proprioceptive cues to maintain postural stability. People with vestibular dysfunction experience multiple problems with posture control and movement, including an unsteady gait and various balance-related difficulties. These effects make it very difficult to walk in the dark or on uneven surfaces without risk of falling. They are typically referred for conventional vestibular therapy. Many patients improve with therapeutic intervention. Some patients reach a plateau and do not return to their previous level of function. The BrainPort balance device transmits head position information via electrotactile stimulation of the tongue. With training, patients learn to use the positional information to correct their balance.
Participants meeting the study criteria will be randomized to the perceived stimulation or subliminal stimulation group. All participants will be given baseline assessments of postural stability, balance, and subjective well being according to standardized tests. After completing the baseline assessments, each participant will be trained in the clinic using a standard training protocol with the BrainPort balance device. Each participant will participate in 6 clinical training sessions, over a period of 3 consecutive days. Upon completion of the clinic training sessions, participants will continue with a 7½ week period of home use. During this period, the participant will train with the device for 20 minutes 2 times per day and the clinicians will contact the participants weekly. At the end of the home training period (8 weeks from the beginning of the study), all participants will again undergo the tests given at baseline.
Following the data analysis, subjects that have completed the 8 week study and were originally assigned to the group with inferior results will be given the opportunity to use the device that showed superior results in the data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perceived stimulation | Experimental | Device: Training with the BrainPort balance deviceWhen subjects assigned to the perceived stimulation group increase the intensity of the stimulus, they will feel a tingling sensation on the tongue. The tingling will move on the tongue in relation to where the head/body moves. |
| Subliminal stimulation | Experimental | Device: Training with the BrainPort balance deviceWhen subjects assigned to the subliminal stimulation group increase the intensity of the stimulus, the device provides a stimulus that is below their conscious awareness, so they will not be able to perceive it. The stimulus will move on the tongue in relation to where the head/body moves. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Confirmed diagnosis of peripheral vestibular dysfunction by the following (within 12 months of study enrollment):
- Minimum post 3 months diagnosis with residual balance problems.
- Previously treated with conventional physical therapy, and discharged and/or reached a plateau.
- Functional Ability:
- Able to read and sign the informed consent form.
Key exclusion criteria (19 listed)
- Current oral health problems as determined by health questionnaire and an examination of the oral cavity.
- Any medical condition that would interfere with performance on the assessments.
- Known neuropathies of the tongue.
- Prior exposure to BrainPort balance device.
- History of seizures or epilepsy.
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 |
|---|---|---|
| Training with the BrainPort balance deviceAlso: BrainPort Balance DeviceSubjects are randomly assigned to one of two groups, the perceived stimulation group or the subliminal stimulation group. Some of these devices provide a stimulus that you can feel. Others provide a stimulus that is below conscious awareness. We are conducting this study to determine if one type of stimulation is more effective than the other. | Device | Perceived stimulation, Subliminal stimulation |
Primary outcome
To assess the efficacy of the BrainPort balance device in improving balance and gait as measured by the Dynamic Gait Index (DGI) in subjects with documented peripheral vestibular dysfunction
Time frame: Baseline and 8 weeks (end of study)
3 secondary outcomes
To assess the safety of electrical stimulation of the tongue during the use of the BrainPort balance device in subjects with documented peripheral vestibular dysfunction.
Time frame: Baseline and ongoing for the duration of the study (8 weeks).
To assess improvement in the Activities-specific Balance Confidence scale (ABC).
Time frame: Baseline and 8 weeks (end of study)
To assess improvement in the Dizziness Handicap Inventory (DHI).
Time frame: Baseline and 8 weeks (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
- Background: PubMed 18413905Danilov YP, Tyler ME, Skinner KL, Hogle RA, Bach-y-Rita P. Efficacy of electrotactile vestibular substitution in patients with peripheral and central vestibular loss. J Vestib Res. 2007;17(2-3):119-30.
- 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.
- Background: PubMed 15988797Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.
- Background: PubMed 17959464Danilov YP, Tyler ME, Skinner KL, Bach-y-Rita P. Efficacy of electrotactile vestibular substitution in patients with bilateral vestibular and central balance loss. Conf Proc IEEE Eng Med Biol Soc. 2006;Suppl:6605-9. doi: 10.1109/IEMBS.2006.260899.
- Background: PubMed 16385646Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.
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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.
James O. Phillips, PhD principal investigator
University of Washington
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with the BrainPort balance device in people with Vestibular Diseases and Gait Disorders, run by Wicab at 17 sites in United States.
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 12 inclusion and 19 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: finished, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the efficacy of the BrainPort balance device in improving balance and gait as measured by the Dynamic Gait Index (DGI) in subjects with documented peripheral vestibular dysfunction (time frame: Baseline and 8 weeks (end of study)). 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 NCT00768378, which also lists 6 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 28 Jun 2012.