This study is now closed.
External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for the treatment of Major Depressive Disorder (MDD)
About the Study
The purpose of this research is to evaluate whether a take-home, self-administered, neurostimulation device called Relivion®DP is safe and helpful for reducing symptoms of Major Depressive Disorder (MDD). An earlier pilot study demonstrated positive results, so the company who develops the device, Neurolief, is conducting this study to further evaluate its use.
Participation in this study includes up to 6 visits at Butler Hospital’s Neuromodulation Research facility. Additional interactions with research staff may take place remotely using digital means such as a phone or video call. You will receive a device to use at home that delivers either active (real) stimulation OR non-active (sham) stimulation during the Double-Blind phase of this study.
You will be asked to perform daily treatments with the device for 8 weeks, after which you may have the option to continue for an additional 8 weeks in an “open-label” phase during which you know you are getting real stimulation from the device, regardless of whether you received active or non-active stimulation during the Double-Blind phase.
If you are eligible and agree to take part in this research study, you will be paid up to $300 for completion of all 6 study visits ($50 per visit). The study device will be provided at no charge to you by the study sponsor and must be returned at the conclusion of your study participation.
Eligibility Requirements
- 18 to 70 years of age
- Primary diagnosis of MDD
- Did not respond or have insufficiently responded to at least one antidepressant medication
