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"Take-home" functional electrical stimulation for depression: protocol for a prototype development and proof of
Fatemeh Gholamali Nezhad1, Vanessa K Tassone1, Ilya Demchenko1,2
1Interventional Psychiatry Program, St. Michael's Hospital, Unity Health Toronto, 193 Yonge Street 6 - 013, Toronto, ON, M5B 1M4, Canada.
Pilot and Feasibility Studies
|May 3, 2025
Summary
This study explores a novel home-based facial muscle electrical stimulation device for major depressive disorder (MDD). The trial will assess the feasibility and safety of this innovative neurostimulation treatment for MDD patients.
Area of Science:
- Neuroscience
- Psychiatry
- Biomedical Engineering
Background:
- Major depressive disorder (MDD) affects many patients unresponsive to conventional treatments.
- Existing neurostimulation therapies for MDD are costly and hospital-dependent.
- Home-based, self-administered neurostimulation offers a potential solution for improved MDD management.
Purpose of the Study:
- To develop a prototype for a take-home functional electrical stimulation (FES) device for MDD.
- To conduct a proof-of-concept feasibility trial for home-based FES in MDD patients.
Main Methods:
- A single-site, pilot, double-blind, randomized, sham-controlled trial involving 20 participants over 4 weeks.
- Participants received 20 sessions of either active or sham FES.
- Feasibility, tolerability, safety, and preliminary therapeutic effects on depressive symptoms, anxiety, quality of life, and sleep were evaluated.
Main Results:
- The study aims to collect data to optimize the FES prototype.
- Preliminary data will inform the design of larger, multi-site randomized controlled trials.
- The trial will assess feasibility, tolerability, and safety of the home-based FES device.
Conclusions:
- Data will guide the optimization of the home-based FES device for MDD.
- Further large-scale trials are needed to confirm the effectiveness of take-home FES.
- The precise mechanism of FES in treating MDD requires further investigation, potentially using neuroimaging.
