Functional Electrical Stimulation for MDD

NCT07629050 | Not Yet Recruiting

• 2 other identifiers: 24-155WI4 179978
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

MDD

Keywords

Major Depressive Disorder; Functional Electrical Stimulation

Outcome Measures

Primary Outcomes (3)

• Efficacy of FES: Change in Depression Severity

  Change in depression severity measured using the 17-item Hamilton Depression Rating Scale (HAM-D-17). Scores range from 0 to 52, with higher scores indicating more severe depressive symptoms.

  4 weeks of Intervention, 4 weeks of follow-up

• Tolerability of FES

  The overall dropout and protocol compliance rates will be assessed.

  4 weeks of Intervention, 4 weeks of follow-up

• FES safety

  The number and nature of adverse events will be assessed

  4 weeks of Intervention, 4 weeks of follow-up

Secondary Outcomes (5)

• Change in Anxiety Symptoms

  4 weeks of Intervention, 4 weeks of follow-up

• Change in Well-Being

  4 weeks of Intervention, 4 weeks of follow-up

• Change in Sleep Quality

  4 weeks of Intervention, 4 weeks of follow-up

• Response and Remission Rate

  4 weeks of Intervention, 4 weeks of follow-up

• Changes in Facial Expressivity

  4 weeks of Intervention

Study Arms (2)

Active FES

EXPERIMENTAL

Functional Electrical Stimulation (FES) will be administered to four facial muscles involved in smiling, with two muscles targeted on each side of the face. Electrodes will be placed over the target muscles, and stimulation will be delivered using standard muscle-activation settings.

Device: Functional Electrical Stimulation (FES)

Sham FES

SHAM COMPARATOR

Sham Functional Electrical Stimulation (FES) will be administered using the same electrode placement and session schedule as the active FES arm. Stimulation will be delivered at a low sensory intensity range of 1-8 mA, sufficient for participants to feel the stimulation, while other parameters will remain the same as in the active arm. Sham stimulation will be delivered in a non-Duchenne smile pattern.

Device: Functional Electrical Stimulation (FES)

Interventions

Functional Electrical Stimulation (FES) DEVICE

Once per day for the duration of 4 weeks. Total of 20 sessions (each session lasts 60 mins)

Active FES; Sham FES

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Unity Health Toronto: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Venkat Bhat

CONTACT

416-360-4000; Venkat.Bhat@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 5, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): April 20, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: June 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share