Could a zap to your face lift your mood? new trial explores FES for depression
NCT ID NCT07629050
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether Functional Electrical Stimulation (FES) of facial muscles is a safe and effective way to reduce depression symptoms in people with major depressive disorder (MDD). About 60 adults with MDD who have not responded to up to two treatments will receive FES or a sham procedure. Researchers will measure changes in depression severity, anxiety, and well-being over 20 sessions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients will be included if they: 1. Meet the DSM-5 criteria for unipolar MDD with a current MDE without psychotic features, with ≤ 2 failed treatment trials (non-treatment-resistant depression), validated by MINI done by a trained research assistant. 2. Have no change in the medication regimen or other forms of treatments (e.g., psychotherapy) for at least 4 weeks (28 days) prior to beginning the study, and have no plan to change them during the 20-session treatment period (14 days), and the 4-week post-treatment observation period. This will be established through self-report, in combination with the ATHF filled out by the participant. 3. Have an MDD diagnosis as confirmed by the MADRS score of ≥7. 4. Age group between 18 and 70 years of age Exclusion Criteria: Patients will be excluded if they: 1. History of epilepsy or seizures. 2. Damage or dysfunction of facial nerves. 3. Metallic orthopedic implants in the mouth (e.g., plates or screws). 4. Current fibromyalgia or currently receiving or have received rTMS within the last 28 days before the screening. 5. History of treatment-resistant depression (TRD) with history of ECT, Magnetic Seizure Therapy, Intravenous Ketamine use in the past or failure of \>2 antidepressant treatments of adequate duration and dose during the current episode. 6. Past or current symptoms of mania, hypomania, mixed episodes, psychotic disorders, obsessive-compulsive disorder, post-traumatic stress disorder, active substance abuse or dependence (excluding nicotine and caffeine), neurodegenerative disease, or dementia. This will be confirmed on the MINI (77) administered by a trained research assistant. 7. Current suicidal intent or plan as demonstrated by a score of ≥4 on MADRS item 10. 8. Unable to understand instructions in English. 9. Unable to produce "Duchenne marker" expression with FES, secondary to any type of neurological condition or previous botulinum toxin treatments of facial muscles.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
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A doctor treating you
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