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Safety and Efficacy Study of BrainPort® Balance Device in Peripheral Vestibular Dysfunction.
This study is currently recruiting participants.
Verified by Wicab, January 2009
Sponsored by: Wicab
Information provided by: Wicab
ClinicalTrials.gov Identifier: NCT00768378
  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

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy 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

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 ]

Estimated Enrollment: 242
Study Start Date: July 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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

Contacts
Contact: Kevin Siewert 608-829-4513 ksiewert@wicab.com

Locations
United States, California
England Physical Therapy Recruiting
Los Angeles, California, United States, 92840
Contact: Teresa England, MPT     714-703-8477     teresapt@msn.com    
Principal Investigator: Teresa England, MPT            
United States, Florida
Sensory Therapeutics, Inc. Recruiting
Jupiter, Florida, United States, 33458
Contact: Rose Ann Curboy, MS, OTR/L     561-745-0028     sensorytherapeut@bellsouth.net    
Principal Investigator: John Li, MD, FACS            
United States, Georgia
Atlanta Ear Clinic Recruiting
Atlanta, Georgia, United States, 30342
Contact: Gaye Cronin, OTR     404-851-9093     earclinic@mindspring.com    
Principal Investigator: Ron Steenerson, MD            
Medical College of Georgia Recruiting
Augusta, Georgia, United States, 30912
Contact: Lisa Barnhill     706-621-6100     lbarnhill@mail.mcg.edu    
Principal Investigator: Brian McKinnon, MD            
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Laura Zahner, PT     913-588-3097     lzahner@kumc.edu    
Principal Investigator: Nandini Deshpande, PT, PhD            
United States, Missouri
Missouri State University Recruiting
Springfield, Missouri, United States, 65897
Contact: Susan Robinson, PT, DPT     417-836-6013     susanrobinson@missouristate.edu    
Principal Investigator: Susan Robinson, PT, DPT            
United States, New York
New York Eye and Ear Infirmary Recruiting
New York, New York, United States, 10010
Contact: Laura Lei Rivera, PT     646-438-7804     llei@nyee.edu    
Contact: Anu Abraham, PT     646-438-7804     aabraham@nyee.edu    
Principal Investigator: Ana Kim, MD            
United States, Oregon
Progressive Rehab Associates Recruiting
Portland, Oregon, United States, 97225
Contact: Kathy De Domingo     503-292-0765     Kathy@progrehab.com    
Principal Investigator: Kevi Ames, PT            
United States, Texas
360 Balance Therapy of Texas Recruiting
Austin, Texas, United States, 78757
Contact: Bridgett Wallace, PT     512-345-4664 ext 100     bridgett@360balance.com    
Principal Investigator: Bridgett Wallace, PT            
Austin ENT Clinic Recruiting
Austin, Texas, United States, 78705
Contact: Tammi Schreiner, LVN     512-323-2432     tschreiner@austinent.com    
Principal Investigator: John R McFarlane, Sr., MD            
United States, Washington
Pacific Balance and Rehabilitation Clinic Recruiting
Seattle, Washington, United States, 98109
Contact: Julie Grove, PT     206-448-1906     jgrove@pbrcseattle.com    
Principal Investigator: Julie Grove, PT            
United States, Wisconsin
Aurora St. Luke's Medical Center Not yet recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Phyllis Runningen, RN, BSN     414-385-2712     phyllis.runningen@aurora.org    
Principal Investigator: Scott Hardin, MD            
Aurora BayCare Medical Center Not yet recruiting
Green Bay, Wisconsin, United States, 54308
Contact: Bridget Kulick, PT     920-288-4709     bridget.kulick@aurorabaycare.com    
Principal Investigator: Bridget Kulick, PT            
Sponsors and Collaborators
Wicab
Investigators
Principal Investigator: James O. Phillips, PhD University of Washington
  More Information

Click here for more information about this study: Safety and Efficacy Study of the BrainPort balance device.  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Wicab, Inc. ( Kim Skinner, MPT )
Study ID Numbers: WCB1-005, NIH: 2R44 DC004738
Study First Received: October 6, 2008
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00768378  
Health Authority: United States: Institutional Review Board

Keywords provided by Wicab:
Physical Therapy (Specialty)
Balance dysfunction or disorder
Vestibular
Rehabilitation

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Vestibular Diseases
Ear Diseases

Additional relevant MeSH terms:
Labyrinth Diseases

ClinicalTrials.gov processed this record on January 15, 2009