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Peer-reviewedCC BY 4.0PLOS One

Functional electrical stimulation for major depressive disorder: Protocol for a pilot randomized controlled trial

  • Fatemeh Gholamali Nezhad1
  • Haochen Yu2
  • Ilya Demchenko3
  • Stephanie N. Iwasa4
  • Stephanie DiNunzio5
  • Rayna Ghosh6
  • José Zariffa7
  • Kei Masani8
  • Wendy Lou9
  • Benoit H. Mulsant10
  • Hani E. Naguib11
  • Milos R. Popovic12
1 more authors
  • Venkat Bhat13
13 affiliations
  1. 1Interventional Psychiatry Program, St. Michael’s Hospital, Unity Health Toronto, Toronto, Ontario, Canada
  2. 2Institute of Medical Science, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
  3. 3The KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada
  4. 4CRANIA, University Health Network and University of Toronto, Toronto, Ontario, Canada
  5. 5Institute of Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada
  6. 6Rehabilitation Sciences Institute, University of Toronto, Toronto, Ontario, Canada
  7. 7Edward S. Rogers Sr. Department of Electrical and Computer Engineering, University of Toronto, Toronto, Ontario, Canada
  8. 8Lyndhurst Centre, KITE Research Institute–University Health Network, Toronto, Ontario, Canada
  9. 9Division of Biostatistics, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada
  10. 10Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada
  11. 11Centre for Addiction and Mental Health, Toronto, Ontario, Canada
  12. 12Department of Mechanical and Industrial Engineering, University of Toronto, Toronto, Ontario, Canada
  13. 13Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto, Ontario, Canada
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Abstract

Background: Conventional treatments for major depressive disorder (MDD) fail to benefit one-third of patients, underscoring the need for therapies with novel mechanisms of action. Bilateral functional electrical stimulation (FES) of the facial muscles uses electrical currents to activate the muscles involved in facial expression and may offer a novel “mind–body” intervention for MDD. Based on preliminary work demonstrating the feasibility of FES for MDD, this proposed study will assess the efficacy, safety, and tolerability of FES in MDD. Methods: This single-site, double-blind, randomized, sham-controlled pilot trial will enroll 60 participants to evaluate the therapeutic effects of 20 sessions of bilateral facial FES over four weeks. The study will assess the impact of FES on depressive symptoms, associated anxiety, quality of life, and sleep. Participant dropout and protocol adherence will be monitored to assess tolerability, while adverse events will be monitored to assess safety throughout the trial. Eligible participants will complete 20 on-site intervention visits and 6 online visits, including a screening visit, a baseline visit, and four post-stimulation follow-up visits. Discussion: The findings from this trial will guide the development of a multisite, large-scale randomized controlled trial and inform further refinement of FES treatment parameters for this population. Trial registration: This trial was registered at the National Library of Medicine, National Center for Biotechnology Information (ClinicalTrials.gov: NCT07629050. Date registered: 2026-06-08).

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Cite

BibTeXRIS
BibTeX
@article{nezhad2026functional,
  title = {{Functional electrical stimulation for major depressive disorder: Protocol for a pilot randomized controlled trial}},
  author = {Fatemeh Gholamali Nezhad and Haochen Yu and Ilya Demchenko and Stephanie N. Iwasa and Stephanie DiNunzio and Rayna Ghosh and José Zariffa and Kei Masani and Wendy Lou and Benoit H. Mulsant and Hani E. Naguib and Milos R. Popovic and Venkat Bhat},
  journal = {PLOS One},
  year = {2026},
  month = sep,
  doi = {10.1371/journal.pone.0357381},
  url = {https://doi.org/10.1371/journal.pone.0357381},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Functional electrical stimulation for major depressive disorder: Protocol for a pilot randomized controlled trial
AU  - Fatemeh Gholamali Nezhad
AU  - Haochen Yu
AU  - Ilya Demchenko
AU  - Stephanie N. Iwasa
AU  - Stephanie DiNunzio
AU  - Rayna Ghosh
AU  - José Zariffa
AU  - Kei Masani
AU  - Wendy Lou
AU  - Benoit H. Mulsant
AU  - Hani E. Naguib
AU  - Milos R. Popovic
AU  - Venkat Bhat
PY  - 2026
DA  - 2026/09/10
JO  - PLOS One
DO  - 10.1371/journal.pone.0357381
UR  - https://doi.org/10.1371/journal.pone.0357381
AB  - Background: Conventional treatments for major depressive disorder (MDD) fail to benefit one-third of patients, underscoring the need for therapies with novel mechanisms of action. Bilateral functional electrical stimulation (FES) of the facial muscles uses electrical currents to activate the muscles involved in facial expression and may offer a novel “mind–body” intervention for MDD. Based on preliminary work demonstrating the feasibility of FES for MDD, this proposed study will assess the efficacy, safety, and tolerability of FES in MDD. Methods: This single-site, double-blind, randomized, sham-controlled pilot trial will enroll 60 participants to evaluate the therapeutic effects of 20 sessions of bilateral facial FES over four weeks. The study will assess the impact of FES on depressive symptoms, associated anxiety, quality of life, and sleep. Participant dropout and protocol adherence will be monitored to assess tolerability, while adverse events will be monitored to assess safety throughout the trial. Eligible participants will complete 20 on-site intervention visits and 6 online visits, including a screening visit, a baseline visit, and four post-stimulation follow-up visits. Discussion: The findings from this trial will guide the development of a multisite, large-scale randomized controlled trial and inform further refinement of FES treatment parameters for this population. Trial registration: This trial was registered at the National Library of Medicine, National Center for Biotechnology Information (ClinicalTrials.gov: NCT07629050. Date registered: 2026-06-08).
SN  - 1932-6203
ER  -