TNS in MDD: Dose Finding

Primary Investigator: Ian A. Cook, MD – Trigeminal nerve stimulation (TNS) therapy is a technique that involves stimulation of the trigeminal nerve by sending a very small electrical signal from electrodes on the surface of the skin, into nerves located in the skin (“transcutaneously”). The trigeminal nerve carries signals to the brain from sensations on the face and in this project it will carry the electrical signal as well. Participants wear an ipod-sized device with electrodes that adhere to the forehead for a certain amount of time throughout the day. In this trial, that period is eight hours a day while sleeping. The primary purpose of this study is to determine whether this treatment is useful in helping to control the symptoms of depression. Another important interest is the safety and patients’ tolerability of the treatment. Two different frequencies will be used to determine which level, if any, is optimal for treatment. Also, an EEG will be recorded on different occasions to determine the treatment’s possible effects on brainwaves. Finally, six monthly checkups following the completion of treatment will provide researchers with an idea of its long-term effects.