Device Dossier

Transcranial electrical stimulation system, continuous-current

Device Dossier for Transcranial electrical stimulation system, continuous-current (Transcranial electrical stimulation system, continuous-current, Class…

Intended purpose

Transcranial Direct Current Stimulation (tDCS) is a non-invasive procedure in which a device sends a small Direct Current (DC) across the scalp to modulate brain function. The 1x1 tDCS Low-Intensity Stimulator sends a low-level current from the positive electrode, anode, to the negative electrode, cathode. When the extremely low level current passes from the anode to the cathode, it simultaneously increases the activity of the brain by the anode and decreases the activity of the brain near the cathode. The device is intended to treat different neurological and psychiatric disorders. In particular, tDCS increases spontaneous brain activity and metabolism in areas found to be hypoactive in patients suffering from major depressive disorder. Per application for pain, primary motor cortex tDCS interfers with perceptual processing of pain while prefrontal cortex stimulation modulates the affective reaction to painful experiences.

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