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

Vestibular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768378
• Other study ID #: WCB1-005
• Secondary ID: NIH: 2R44 DC0047
• Status: Completed
• Phase: N/A
• First received: October 6, 2008
• Last updated: June 27, 2012
• Start date: July 2008
• Est. completion date: March 2010

Study information

• Verified date: June 2012
• Source: Wicab
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Gait Disorders
• Vestibular Diseases

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.

Locations

Country	Name	City	State
United States	Atlanta Ear Clinic	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	Elks Hearing & Balance Center	Boise	Idaho
United States	Lahey Clinic	Burlington	Massachusetts
United States	South Valley Physical Therapy, PC	Centennial	Colorado
United States	Houston ENT Clinic	Houston	Texas
United States	Sensory Therapeutics, Inc.	Jupiter	Florida
United States	Kansas University Medical Center	Kansas City	Kansas
United States	England Physical Therapy	Los Angeles	California
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	NBC Rehabilitation	N. Miami Beach	Florida
United States	New York Eye and Ear Infirmary	New York	New York
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	Pacific Balance and Rehabilitation Clinic	Seattle	Washington
United States	University of Washington School of Medicine	Seattle	Washington
United States	Missouri State University	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Wicab

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bach-y-Rita P, W Kercel S. Sensory substitution and the human-machine interface. Trends Cogn Sci. 2003 Dec;7(12):541-6. — View Citation

Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. Review. — View Citation

Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline and 8 weeks (end of study)	No
Secondary	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.		Baseline and ongoing for the duration of the study (8 weeks).	Yes
Secondary	To assess improvement in the Activities-specific Balance Confidence scale (ABC).		Baseline and 8 weeks (end of study)	No
Secondary	To assess improvement in the Dizziness Handicap Inventory (DHI).		Baseline and 8 weeks (end of study)	No

External Links

•   Click here for more information about this study: Safety and Efficacy Study of the BrainPort balance device.