Evidence map›Paper›PMID 42721198›Full record

ArticlePloS one2026

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

Fatemeh Gholamali Nezhad, Haochen Yu, Ilya Demchenko, Stephanie N Iwasa, Stephanie DiNunzio, Rayna Ghosh, José Zariffa, Kei Masani, Wendy Lou, Benoit H Mulsant and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07629050 (Functional Electrical Stimulation for Major Depressive Disorder), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07629050 nanot yet recruitingnot on this map

Functional Electrical Stimulation for Major Depressive Disorder: A Pilot Randomized Control Trial

TypeinterventionalSponsorUnity Health TorontoRan2026 to 2029Enrolled60ConditionsMDDArmsFunctional Electrical Stimulation (FES)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Fatemeh Gholamali NezhadInterventional Psychiatry Program, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
Haochen YuInterventional Psychiatry Program, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.
Ilya DemchenkoInterventional Psychiatry Program, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0001-7876-4981
Stephanie N IwasaThe KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.
Stephanie DiNunzioThe KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.
Rayna GhoshInstitute of Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada.
José ZariffaThe KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0002-8842-745X
Kei MasaniInstitute of Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0002-0207-3241
Wendy LouDivision of Biostatistics, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
Benoit H MulsantInstitute of Medical Science, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0002-0303-6450
Hani E NaguibDepartment of Mechanical and Industrial Engineering, University of Toronto, Toronto, Ontario, Canada.
Milos R PopovicThe KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.
Venkat BhatInterventional Psychiatry Program, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.ORCID https://orcid.org/0000-0002-8768-1173

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConventional 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.

methodsThis 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 registrationThis trial was registered at the National Library of Medicine, National Center for Biotechnology Information (ClinicalTrials.gov: NCT07629050. Date registered: 2026-06-08).

Indexed as

Electric Stimulation TherapyMajor Depressive DisorderAdultDouble-Blind MethodFacial MusclesFemaleHumansMaleMiddle AgedPilot ProjectsQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeYoung Adult

Identifiers

PMID42721198
PMCPMC13561349

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.