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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wicab
ClinicalTrials.gov Identifier:
NCT00768378
First received: October 6, 2008
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Vestibular Diseases
Gait Disorders
Device: Training with the BrainPort balance device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Wicab:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: Yes ]
  • To assess improvement in the Activities-specific Balance Confidence scale (ABC). [ Time Frame: Baseline and 8 weeks (end of study) ] [ Designated as safety issue: No ]
  • To assess improvement in the Dizziness Handicap Inventory (DHI). [ Time Frame: Baseline and 8 weeks (end of study) ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: July 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768378

Locations
United States, California
England Physical Therapy
Los Angeles, California, United States, 92840
United States, Colorado
South Valley Physical Therapy, PC
Centennial, Colorado, United States, 80111
United States, Florida
Sensory Therapeutics, Inc.
Jupiter, Florida, United States, 33458
NBC Rehabilitation
N. Miami Beach, Florida, United States, 33160
United States, Georgia
Atlanta Ear Clinic
Atlanta, Georgia, United States, 30342
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Idaho
Elks Hearing & Balance Center
Boise, Idaho, United States, 83702
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Missouri
Missouri State University
Springfield, Missouri, United States, 65897
United States, New York
New York Eye and Ear Infirmary
New York, New York, United States, 10010
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Texas
Houston ENT Clinic
Houston, Texas, United States, 77024
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Pacific Balance and Rehabilitation Clinic
Seattle, Washington, United States, 98109
United States, Wisconsin
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Wicab
Investigators
Principal Investigator: James O. Phillips, PhD University of Washington
  More Information