Back to resultsSafety and Efficacy Study of BrainPort® Balance Device in Peripheral Vestibular Dysfunction.
Primary Purpose
Vestibular Diseases, Gait Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training with the BrainPort balance device
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Diseases focused on measuring Physical Therapy (Specialty), Balance dysfunction or disorder, Vestibular, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of peripheral vestibular dysfunction by the following (within 12 months of study enrollment):
- 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.
- Unilateral Vestibular Hypofunction (UVH)-Bithermal caloric test results of > 25% unilateral weakness.
- Minimum post 3 months diagnosis with residual balance problems.
- Previously treated with conventional physical therapy, and discharged and/or reached a plateau.
Functional Ability:
- Able to ambulate independently or with an assistive device for 20 feet.
- Ability to stand independently for 2 minutes with no or minimal upper extremity support.
- Dynamic Gait Index ≤ 19/24.
- Able to read and sign the informed consent form.
- Fluent in English.
- Willing and able to complete all testing, training, and follow-up evaluations required by the study protocol.
Exclusion Criteria:
- Current oral health problems as determined by health questionnaire and an examination of the oral cavity.
- Any medical condition that would interfere with performance on the assessments.
- Known neuropathies of the tongue.
- Prior exposure to BrainPort balance device.
- History of seizures or epilepsy.
- If female, pregnant. Subject must deny pregnancy and agree to use appropriate birth control to prevent pregnancy for the duration of the study.
- People with implanted electrical medical devices (i.e. pacemaker, deep brain stimulator).
- People currently taking any vestibular suppressant medication (i.e. barbiturates, benzodiazepines, betahistines or cortisone).
- People with a previous diagnosis of a central nervous system lesion (e.g. stroke or brain injury).
Current diagnosis of any of the following:
- Bilateral areflexia (no response to ice water caloric testing bilaterally)
- Progressive neurological disease (such as Multiple Sclerosis)
- Cervicogenic dizziness
- Pre-syncope/syncope episodes
- Orthostatic hypotension
- Mood Disorders (such as Major Depression and Bipolar Disorder)
- Anxiety disorders
- Hydrops / Ménière's
- Principal Investigator, in his or her medical judgment, does not believe the subject is a good candidate for the trial.
Sites / Locations
- England Physical Therapy
- South Valley Physical Therapy, PC
- Sensory Therapeutics, Inc.
- NBC Rehabilitation
- Atlanta Ear Clinic
- Medical College of Georgia
- Elks Hearing & Balance Center
- Kansas University Medical Center
- Lahey Clinic
- Missouri State University
- New York Eye and Ear Infirmary
- University of Rochester Medical Center
- Houston ENT Clinic
- Eastern Virginia Medical School
- Pacific Balance and Rehabilitation Clinic
- University of Washington School of Medicine
- Aurora St. Luke's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Perceived stimulation
Subliminal stimulation
Arm Description
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.
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.
Outcomes
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
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.
To assess improvement in the Activities-specific Balance Confidence scale (ABC).
To assess improvement in the Dizziness Handicap Inventory (DHI).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00768378
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wicab
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Diseases, Gait Disorders
Keywords
Physical Therapy (Specialty), Balance dysfunction or disorder, Vestibular, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perceived stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Subliminal stimulation
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Training with the BrainPort balance device
Other Intervention Name(s)
BrainPort Balance Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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).
Title
To assess improvement in the Activities-specific Balance Confidence scale (ABC).
Time Frame
Baseline and 8 weeks (end of study)
Title
To assess improvement in the Dizziness Handicap Inventory (DHI).
Time Frame
Baseline and 8 weeks (end of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of peripheral vestibular dysfunction by the following (within 12 months of study enrollment):
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.
Unilateral Vestibular Hypofunction (UVH)-Bithermal caloric test results of > 25% unilateral weakness.
Minimum post 3 months diagnosis with residual balance problems.
Previously treated with conventional physical therapy, and discharged and/or reached a plateau.
Functional Ability:
Able to ambulate independently or with an assistive device for 20 feet.
Ability to stand independently for 2 minutes with no or minimal upper extremity support.
Dynamic Gait Index ≤ 19/24.
Able to read and sign the informed consent form.
Fluent in English.
Willing and able to complete all testing, training, and follow-up evaluations required by the study protocol.
Exclusion Criteria:
Current oral health problems as determined by health questionnaire and an examination of the oral cavity.
Any medical condition that would interfere with performance on the assessments.
Known neuropathies of the tongue.
Prior exposure to BrainPort balance device.
History of seizures or epilepsy.
If female, pregnant. Subject must deny pregnancy and agree to use appropriate birth control to prevent pregnancy for the duration of the study.
People with implanted electrical medical devices (i.e. pacemaker, deep brain stimulator).
People currently taking any vestibular suppressant medication (i.e. barbiturates, benzodiazepines, betahistines or cortisone).
People with a previous diagnosis of a central nervous system lesion (e.g. stroke or brain injury).
Current diagnosis of any of the following:
Bilateral areflexia (no response to ice water caloric testing bilaterally)
Progressive neurological disease (such as Multiple Sclerosis)
Cervicogenic dizziness
Pre-syncope/syncope episodes
Orthostatic hypotension
Mood Disorders (such as Major Depression and Bipolar Disorder)
Anxiety disorders
Hydrops / Ménière's
Principal Investigator, in his or her medical judgment, does not believe the subject is a good candidate for the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James O. Phillips, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
England Physical Therapy
City
Los Angeles
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
South Valley Physical Therapy, PC
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Sensory Therapeutics, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
NBC Rehabilitation
City
N. Miami Beach
State/Province
Florida
ZIP/Postal Code
33160
Country
United States
Facility Name
Atlanta Ear Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Elks Hearing & Balance Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Missouri State University
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65897
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Houston ENT Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Pacific Balance and Rehabilitation Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18413905
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.
Results Reference
background
PubMed Identifier
14643370
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.
Results Reference
background
PubMed Identifier
15011268
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.
Results Reference
background
PubMed Identifier
15988797
Citation
Bach-Y-Rita P. Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. doi: 10.1142/s0219635205000768.
Results Reference
background
PubMed Identifier
17959464
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.
Results Reference
background
PubMed Identifier
16385646
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.
Results Reference
background
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Safety and Efficacy Study of BrainPort® Balance Device in Peripheral Vestibular Dysfunction.
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