NCT07629050Not yet recruiting
Functional Electrical Stimulation for MDD
Functional Electrical Stimulation for Major Depressive Disorder: A Pilot Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 May 2026
- Start date
- 25 May 2026
- Primary completion date
- 20 Apr 2028
- Lead sponsor
- Unity Health Toronto
- Diseases
- Depression
- NCT number
- NCT07629050
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 25 May 2026 to the primary completion date, 20 Apr 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Unable to produce "Duchenne marker" expression with FES, secondary to any type of neurological condition or previous botulinum toxin treatments of facial muscles.
Other illness
- History of epilepsy or seizures.
- 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.
Other
- Patients will be excluded if they:
- Damage or dysfunction of facial nerves.
- Current suicidal intent or plan as demonstrated by a score of ≥4 on MADRS item 10.
- Unable to understand instructions in English.
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Related publications
- Functional electrical stimulation for major depressive disorder: Protocol for a pilot randomized controlled trial.PLoS One · 2026 · PMID 42721198
This page is information, not medical advice. Discuss any trial with your doctor.