Status:
COMPLETED
Safety and Efficacy Study of BrainPort® Balance Device in Peripheral Vestibular Dysfunction.
Lead Sponsor:
Wicab
Conditions:
Vestibular Diseases
Gait Disorders
Eligibility:
All Genders
18-79 years
Phase:
NA
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 subj...
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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00768378
Start Date
July 1 2008
End Date
March 1 2010
Last Update
June 28 2012
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
England Physical Therapy
Los Angeles, California, United States, 92840
2
South Valley Physical Therapy, PC
Centennial, Colorado, United States, 80111
3
Sensory Therapeutics, Inc.
Jupiter, Florida, United States, 33458
4
NBC Rehabilitation
North Miami Beach, Florida, United States, 33160