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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

Full criteria on ClinicalTrials.gov

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.