Wearable Functional Electrical Stimulation System with Novel Electrodes and Compliant Textile Electronics

Project Synopsis

A substantial proportion of Canadians suffer from Major Depressive Disorder (MDD), with an annual prevalence of 4.8% and lifetime prevalence of 12.2%. MDD is the leading cause of disability, and currently available treatments are associated with side effects and low adherence. Hospitalbased neurostimulation modalities for MDD (e.g., Electroconvulsive therapy [ECT], repetitive Transcranial Magnetic Stimulation [rTMS]) are difficult to access, are associated with high costs for delivery inhospital for the acute treatment of MDD, and maintenance treatments are often needed to sustain efficacy. While there are few lowcost homebased treatments (e.g., light therapy, transcranial direct current stimulation [tDCS], computerbased psychotherapy), their efficacy is modest. Thus, there is a critical need for efficacious and welltolerated homebased neurostimulation treatments which could be selfadministered at a frequency required to treat MDD, maintain response, and reduce relapse.

Project Objective

The project has two principal objectives-A) Development of a takehome FES device. B) Preliminary demonstration of feasibility, acceptability and early efficacy. Based on the results of this study, a larger 1year Phase 2B randomized clinical trial (RCT) will be conducted. A 1year Phase 2B RCT will be needed to further refine intervention parameters to optimize acceptability and efficacy to then plan the definitive Phase 3 trial with a view to obtaining FDA approval for thetakehomeFES device as a treatment for MDD.