Clinical trial NCT00768378: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Diseases
Gait Disorders
Keywords: Physical Therapy (Specialty)
Balance dysfunction or disorder
Vestibular
Rehabilitation
Lead sponsor: Wicab
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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
timeFrame: Baseline and 8 weeks (end of study)
Secondary outcomes:
measure: 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.
timeFrame: Baseline and ongoing for the duration of the study (8 weeks).
measure: To assess improvement in the Activities-specific Balance Confidence scale (ABC).
timeFrame: Baseline and 8 weeks (end of study)
measure: To assess improvement in the Dizziness Handicap Inventory (DHI).
timeFrame: Baseline and 8 weeks (end of study)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: England Physical Therapy
state: California
city: Centennial
country: United States
facility: South Valley Physical Therapy, PC
state: Colorado
city: Jupiter
country: United States
facility: Sensory Therapeutics, Inc.
state: Florida
city: N. Miami Beach
country: United States
facility: NBC Rehabilitation
state: Florida
city: Atlanta
country: United States
facility: Atlanta Ear Clinic
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Boise
country: United States
facility: Elks Hearing & Balance Center
state: Idaho
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Springfield
country: United States
facility: Missouri State University
state: Missouri
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Houston
country: United States
facility: Houston ENT Clinic
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Seattle
country: United States
facility: Pacific Balance and Rehabilitation Clinic
state: Washington
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: University of Washington
name: James O. Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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. doi: 10.1142/s0219635203000263.
citation: Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.
citation: 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. doi: 10.1109/IEMBS.2006.260899.
citation: Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.