Evidence map›Paper›PMID 40319334›Full record

ArticlePilot and feasibility studies2025

"Take-home" functional electrical stimulation for depression: protocol for a prototype development and proof of concept randomized controlled trial.

Fatemeh Gholamali Nezhad, Vanessa K Tassone, Ilya Demchenko, Jia Xi Mary Chen, Stephanie N Iwasa, Josh Martin, Naaz Desai, Hani E Naguib, Milos R Popovic, Venkat Bhat

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06261177 ("Take-Home" Functional Electrical Stimulation for Depression), 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.

NCT06261177 naactive not recruitingnot on this map

"Take-Home" Functional Electrical Stimulation for Depression: Prototype Development and Proof of Concept Clinical Trial

TypeinterventionalSponsorUnity Health TorontoRan2023 to 2028Enrolled20ConditionsMDDArmsFunctional Electrical Stimulation (FES), Sham 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

10 authors.

Fatemeh Gholamali NezhadInterventional Psychiatry Program, St. Michael's Hospital, Unity Health Toronto, 193 Yonge Street 6 - 013, Toronto, ON, M5B 1M4, Canada.
Vanessa K TassoneInterventional Psychiatry Program, St. Michael's Hospital, Unity Health Toronto, 193 Yonge Street 6 - 013, Toronto, ON, M5B 1M4, Canada.
Ilya DemchenkoInterventional Psychiatry Program, St. Michael's Hospital, Unity Health Toronto, 193 Yonge Street 6 - 013, Toronto, ON, M5B 1M4, Canada.
Jia Xi Mary ChenThe KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada.
Stephanie N IwasaThe KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada.
Josh MartinInterventional Psychiatry Program, St. Michael's Hospital, Unity Health Toronto, 193 Yonge Street 6 - 013, Toronto, ON, M5B 1M4, Canada.
Naaz DesaiThe KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada.
Hani E NaguibThe KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada.
Milos R PopovicThe KITE Research Institute, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada.
Venkat BhatInterventional Psychiatry Program, St. Michael's Hospital, Unity Health Toronto, 193 Yonge Street 6 - 013, Toronto, ON, M5B 1M4, Canada. venkat.bhat@utoronto.ca.ORCID http://orcid.org/0000-0002-8768-1173

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOne-third of patients with major depressive disorder (MDD) will not achieve a clinically meaningful response to available conventional treatments. More effective neurostimulation treatments are difficult to access and are associated with high hospital delivery costs. Patients would benefit from more efficacious and well-tolerated home-based neurostimulation treatments, which could be self-administered at a frequency required to treat MDD, maintain response, and reduce relapse. A potential novel intervention for MDD is bilateral functional electrical stimulation (FES) of the facial muscles. The portable FES stimulator delivers electrical current to excitable tissues and is suitable for home-based use. Based on the preliminary work demonstrating the feasibility of FES for MDD, the proposed study will develop a viable prototype for a "take-home" FES device and perform a proof-of-concept feasibility trial for participants with MDD.

methodsThis is a single-site, pilot, double-blind, randomized, sham-controlled clinical trial, where 20 participants will receive 20 sessions of FES over 4 weeks. The trial will evaluate the feasibility, tolerability, and safety of home-based FES for MDD. We will also collect data on the preliminary therapeutic effects of FES on depressive symptoms and associated anxiety, quality of life, and sleep. Eligible participants will have three on-site visits including one mask development visit, one mask delivery visit, and one follow-up visit at the end of the study. They will also attend 25 online visits including a screening visit, a baseline visit, 20 days of FES treatment (sham or active), and three post-stimulation follow-up visits. DISCUSSION: Data obtained from this trial will be used to optimize the home-based FES prototype and design a follow-up, multi-site, large-scale randomized control trial to assess the effectiveness of take-home FES. The existing evidence suggests that FES of the facial muscles can reduce MDD symptoms by enhancing positive facial feedback and altering the interoceptive bias associated with MDD, but its exact mechanism of action is still under debate. Additional trials with neuroimaging outcomes are needed to elucidate the mechanism of action of FES and the corresponding changes in the central nervous system.

trial registrationThis trial has been registered at the National Library of Medicine, National Center for Biotechnology Information (ClinicalTrials.gov: NCT06261177 . Registered on January 4, 2024).

Indexed as

Facial musclesFeasibility studiesFunctional electrical stimulationMajor depressive disorderNeuromodulationTake-home treatment

Identifiers

PMID40319334
PMCPMC12049065

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.