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

Completed · Not applicable

Conditions studied: Vestibular Diseases, Gait Disorders

In brief

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.

Key facts

Study ID

NCT00768378

Run by

Wicab

People needed

147

Starts

2008-07-01

Expected to finish

2010-03-01

Last updated by the study team

2012-06-28

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.