Grant: Project Grant

Depression has high prevalence, and currently available treatments for depression are difficult to access, have low adherence, or are associated with adverse effects. Further, many of the treatments are hospital-based; there is a great need in both pandemic and non-pandemic contexts for new treatments with alternative mechanisms of action with the potential for home-based use. Recent work from our team suggests utility of repetitive Functional Electrical Stimulation (FES) of the facial muscles responsible for producing a "genuine/Duchenne" smile pattern in treating depression. FES is a technique in which muscles are electrically stimulated in a patterned manner, causing them to contract and has demonstrated benefits for individuals with neurological injuries to retrain various upper and lower limb functions. Based on the Facial Feedback Hypothesis, we propose to conduct the first sham-controlled pilot trial of FES of the facial muscles to treat mild to moderate major depressive disorder (MDD). We propose to randomize 70 patients having non-treatment resistant mild to moderate MDD to 20 sessions of FES or sham-FES delivered over 4 weeks (45 minutes/session, 5 times/week). Research raters, participants, and their treating psychiatrists will be unaware of the treatment arm. In addition to the primary efficacy outcome of reduction in depressive symptoms at the end of 20 sessions, tolerability and other outcomes will form the foundation for a larger, more definitive RCT. Pilot data from the proposed "in-person" study will also inform the development and conduct of studies examining underlying mechanisms of action of FES, and development of "take-home" FES devices for depression. This project is led by an early career investigator and includes an interdisciplinary/international team of senior investigators in biomedical engineering and FES, neurostimulation and clinical trials in depression, psychology, facial expression and prosody, biostatistics, and knowledge users.