NCT00254228 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bach-y-rita P, Danilov YP, Tyler ME, Grimm RF
Late Human Brain Plasticity: Vestibular Substitution with a Tongue BrainPort Human-Machine Interface. Journal Intellectica, 2005 (in press).
Bach-y-Rita P, W Kercel S
Sensory substitution and the human-machine interface. Trends Cogn Sci. 2003 Dec;7(12):541-6.
Bach-Y-Rita P
Emerging concepts of brain function. J Integr Neurosci. 2005 Jun;4(2):183-205. Review.
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.

A Clinical Study to Evaluate the Safety and Efficacy of the BrainPort™ Balance Device When Used to Improve Postural Control in Subjects With Bilateral Vestibular Disorders

Details for clinical trial NCT00254228

Clinical trial NCT00254228 - References