Safety and Efficacy of the BrainPort™ Balance Device to Improve Balance in Bilateral Vestibular H… (NCT00254228) | Clinical Trial Compass
TerminatedNot Applicable
Safety and Efficacy of the BrainPortâ„¢ Balance Device to Improve Balance in Bilateral Vestibular Hypofunction
Stopped: Terminated due to slow recruitment
United States, United Kingdom60 participantsStarted 2005-11
Plain-language summary
The purpose of this study is to determine whether the BrainPortâ„¢ balance device is safe and effective in the treatment of balance disorders in patients with Bilateral Vestibular Dysfunction.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Documented history of acquired bilateral vestibular dysfunction for a duration of at least one year which has been unsuccessfully treated or reached a plateau with conventional vestibular rehabilitation.
* No greater than 2 successful attempts out of 6 on the NeuroCom Equitest Sensory Organization Tests 5 and 6.
* Failure on the Rotary Chair Vestibulo-ocular Reflex (VOR) Test as evidenced by a gain of less than or equal to -2 standard deviations at frequencies of .025, and .05 Hz.
* Normal corrected vision (20/40 or better).
* Able to read and understand the informed consent form, and willing to sign the informed consent form.
* Willing to complete all follow-up evaluations required by the study protocol.
* Able to stand for a period of 20 minutes in a stationary position with weight evenly distributed without moderate pain, muscle cramping or numbness in the lower extremities.
Exclusion Criteria:
* Neurological disorders other than bilateral vestibular disorder, as determined by medical history and neurological screening procedure.
* Current oral health problems as determined by health questionnaire and an examination of the oral cavity.
* Cigarette smokers and those who use chewing tobacco.
* Currently taking either benzodiazepine or barbiturate medication.
* Any medical condition as determined by the health questionnaire that would interfere with performance on the postural stability evaluation tests.
* Known neuropathies of tongue or skin tactile …
What they're measuring
1
Computerized Dynamic Posturography using the NeuroCom Sensory Organization Test (SOT) composite score, taken at baseline, 1 week, 8 weeks and 12 months.