Functional Electrical Stimulation for MDD

Starting soon · Not applicable · Has a placebo group

Conditions studied: MDD

In brief

This study aims to determine whether Functional Electrical Stimulation (FES) of the facial muscles is a safe and effective treatment for major depressive disorder (MDD).

Key facts

Study ID

NCT07629050

Run by

Unity Health Toronto

People needed

60

Starts

2026-05-25

Expected to finish

2029-03-30

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be included if they:
• 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.
• 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.
• Have an MDD diagnosis as confirmed by the MADRS score of ≥7.
• Age group between 18 and 70 years of age

You may not qualify if…

• Patients will be excluded if they:
• History of epilepsy or seizures.
• Damage or dysfunction of facial nerves.
• Metallic orthopedic implants in the mouth (e.g., plates or screws).
• Current fibromyalgia or currently receiving or have received rTMS within the last 28 days before the screening.
• 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.
• 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.
• Current suicidal intent or plan as demonstrated by a score of ≥4 on MADRS item 10.
• Unable to understand instructions in English.
• Unable to produce "Duchenne marker" expression with FES, secondary to any type of neurological condition or previous botulinum toxin treatments of facial muscles.

Full record on ClinicalTrials.gov

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