Single Center, Single Blind, Randomized, Sham Controlled Pilot Study Using Selective Nerve Stimulation (SNS) Signal for Nerve Modulation With Three Amplitudes (Supra-threshold, Sub-threshold and Sham)
The purpose of this study is to examine if a new device, the SNS (Selective Nerve Stimulator), is effective in changing the way nerves work as pain killing drugs sometimes do. During this study, the study team will place 2 adhesive patches on the inside of one of the wrists of the non-dominant hand (if the subject is right-handed the electrodes will be placed on the subject's left wrist) of the study subject. These patches will be connected by wires (leads) to a small box with a headphone jack. This is designed to provide gentle electrical stimulation through the skin. This study will look at the amount of change from normal nerve function, the sensory effects (feeling, sensations in the body), and any changes the subject has when performing the 2 hour tests. The safety of the study device will also be evaluated.
Phase III Study of Pharos Vitesse Neurovascular Stent System Compared to Best Medical Therapy for the Treatment of Ischemic Disease
The main objective of this study is to prospectively evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter, randomized clinical trial.
A secondary objective of this study is to evaluate the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of stay, charges, and costs.
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