Safety and Efficacy Study of BrainPort® Balance Device in Peripheral Vestibular Dysfunction.

• ClinicalTrials.gov Identifier: NCT00768378
• Recruitment Status: Completed
• First Posted: October 8, 2008
• Last Update Posted: June 28, 2012
• Sponsor: Wicab
• Information provided by (Responsible Party): Wicab

Tracking Information

• First Submitted Date: October 6, 2008
• First Posted Date: October 8, 2008
• Last Update Posted Date: June 28, 2012
• Study Start Date: July 2008
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 5, 2009): 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) ]
• Original Primary Outcome Measures (submitted: October 6, 2008): 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 vestibular dysfunction [ Time Frame: Baseline and 8 weeks (end of study) ]
• Change History: Complete list of historical versions of study NCT00768378 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: January 5, 2009)

• 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) ]

Original Secondary Outcome Measures (submitted: October 6, 2008)

• To assess the safety of electrical stimulation of the tongue during the use of the BrainPort balance device in subjects with documented 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) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy Study of BrainPort® Balance Device in Peripheral Vestibular Dysfunction.
• 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
• Brief 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Vestibular Diseases
• Gait Disorders

Intervention

Device: Training with the 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.

Other Name: BrainPort Balance Device

Study Arms

• Experimental: Perceived stimulation
  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.
  Intervention: Device: Training with the BrainPort balance device
• Experimental: Subliminal stimulation
  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.
  Intervention: Device: Training with the BrainPort balance device

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.
• Bach-y-Rita P, W Kercel S. Sensory substitution and the human-machine interface. Trends Cogn Sci. 2003 Dec;7(12):541-6.
• 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.
• Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. Review.
• Danilov 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.
• Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. Review.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 15, 2010): 147
• Original Estimated Enrollment (submitted: October 6, 2008): 242
• Actual Study Completion Date: March 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Confirmed diagnosis of peripheral vestibular dysfunction by the following (within 12 months of study enrollment):

   1. 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.
   2. Unilateral Vestibular Hypofunction (UVH)—Bithermal caloric test results of > 25% unilateral weakness.
2. Minimum post 3 months diagnosis with residual balance problems.
3. Previously treated with conventional physical therapy, and discharged and/or reached a plateau.

4. Functional Ability:

   1. Able to ambulate independently or with an assistive device for 20 feet.
   2. Ability to stand independently for 2 minutes with no or minimal upper extremity support.
   3. Dynamic Gait Index ≤ 19/24.
5. Able to read and sign the informed consent form.
6. Fluent in English.
7. Willing and able to complete all testing, training, and follow-up evaluations required by the study protocol.

Exclusion Criteria:

1. Current oral health problems as determined by health questionnaire and an examination of the oral cavity.
2. Any medical condition that would interfere with performance on the assessments.
3. Known neuropathies of the tongue.
4. Prior exposure to BrainPort balance device.
5. History of seizures or epilepsy.
6. If female, pregnant. Subject must deny pregnancy and agree to use appropriate birth control to prevent pregnancy for the duration of the study.
7. People with implanted electrical medical devices (i.e. pacemaker, deep brain stimulator).
8. People currently taking any vestibular suppressant medication (i.e. barbiturates, benzodiazepines, betahistines or cortisone).
9. People with a previous diagnosis of a central nervous system lesion (e.g. stroke or brain injury).

10. Current diagnosis of any of the following:

    1. Bilateral areflexia (no response to ice water caloric testing bilaterally)
    2. Progressive neurological disease (such as Multiple Sclerosis)
    3. Cervicogenic dizziness
    4. Pre-syncope/syncope episodes
    5. Orthostatic hypotension
    6. Mood Disorders (such as Major Depression and Bipolar Disorder)
    7. Anxiety disorders
    8. Hydrops / Ménière's
11. Principal Investigator, in his or her medical judgment, does not believe the subject is a good candidate for the trial.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00768378
• Other Study ID Numbers: WCB1-005; NIH: 2R44 DC004738
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wicab
• Study Sponsor: Wicab
• Collaborators: Not Provided

Investigators

• Principal Investigator: James O. Phillips, PhD; University of Washington

• PRS Account: Wicab
• Verification Date: June 2012