Functional Electrical Stimulation for MDD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Functional Electrical Stimulation (FES).
- Who it may be relevant to
- Registry conditions: MDD. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Functional Electrical Stimulation for Major Depressive Disorder: A Pilot Randomized Control Trial
Overview
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).
Detailed description
A potential new treatment for Major Depressive Disorder (MDD) involves using a Functional Electrical Stimulation (FES) device to stimulate specific facial muscles. By targeting muscles related to smile patterns, FES has shown promise in improving emotional control and boosting mood. This project aims to address a critical need for innovative treatments for MDD, especially since 30% of MDD patients do not respond to traditional treatments.
This is a single-site clinical trial that is double-blind, randomized, and sham-controlled, involving 20 sessions of FES over four weeks. The trial will assess the effectiveness, safety, and tolerability of FES for individuals with mild-to-moderate major depressive episode (MDE) and a primary diagnosis of MDD.
Participants in the study will have a total of 26 visits: one screening and one baseline visit (both conducted by phone), followed by 20 on-site intervention visits over four weeks (one sessions per day). After the treatment, there will also be four follow-up visits over the phone to check how long the effects of the FES treatment last.
Interventions
- Device Functional Electrical Stimulation (FES)
Once per day for the duration of 4 weeks. Total of 20 sessions (each session lasts 60 mins)
Primary outcome measures
- Efficacy of FES: Change in Depression Severity [Time frame: 4 weeks of Intervention, 4 weeks of follow-up]
- Tolerability of FES [Time frame: 4 weeks of Intervention, 4 weeks of follow-up]
- FES safety [Time frame: 4 weeks of Intervention, 4 weeks of follow-up]
Secondary outcome measures (5)
- Change in Anxiety Symptoms [Time frame: 4 weeks of Intervention, 4 weeks of follow-up]
- Change in Well-Being [Time frame: 4 weeks of Intervention, 4 weeks of follow-up]
- Change in Sleep Quality [Time frame: 4 weeks of Intervention, 4 weeks of follow-up]
- Response and Remission Rate [Time frame: 4 weeks of Intervention, 4 weeks of follow-up]
- Changes in Facial Expressivity [Time frame: 4 weeks of Intervention]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07629050 · 24-155 · WI4 179978