MDD
Conditions
Keywords
Major Depressive Disorder, Functional Electrical Stimulation
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).
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
Once per day for the duration of 4 weeks. Total of 20 sessions (each session lasts 60 mins)
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients will be included if they: 1. 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. 2. 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. 3. Have an MDD diagnosis as confirmed by the MADRS score of ≥7. 4. Age group between 18 and 70 years of age
Exclusion criteria
Patients will be excluded if they: 1. History of epilepsy or seizures. 2. Damage or dysfunction of facial nerves. 3. Metallic orthopedic implants in the mouth (e.g., plates or screws). 4. Current fibromyalgia or currently receiving or have received rTMS within the last 28 days before the screening. 5. 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. 6. 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. 7. Current suicidal intent or plan as demonstrated by a score of ≥4 on MADRS item 10. 8. Unable to understand instructions in English. 9. Unable to produce "Duchenne marker" expression with FES, secondary to any type of neurological condition or previous botulinum toxin treatments of facial muscles.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of FES: Change in Depression Severity | 4 weeks of Intervention, 4 weeks of follow-up | 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. |
| Tolerability of FES | 4 weeks of Intervention, 4 weeks of follow-up | The overall dropout and protocol compliance rates will be assessed. |
| FES safety | 4 weeks of Intervention, 4 weeks of follow-up | The number and nature of adverse events will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Symptoms | 4 weeks of Intervention, 4 weeks of follow-up | Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity. |
| Change in Well-Being | 4 weeks of Intervention, 4 weeks of follow-up | Well-being will be assessed using the World Health Organization-Five Well-Being Index. Raw total scores range from 0 to 25, with higher scores indicating better well-being. |
| Change in Sleep Quality | 4 weeks of Intervention, 4 weeks of follow-up | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Global scores range from 0 to 21, with higher scores indicating poorer sleep quality. |
| Response and Remission Rate | 4 weeks of Intervention, 4 weeks of follow-up | Response and Remission will be assessed using the 17-item Hamilton Depression Rating Scale. Total scores on the 17-item Hamilton Depression Rating Scale range from 0 to 52, with higher scores indicating greater depression symptom severity. |
| Changes in Facial Expressivity | 4 weeks of Intervention | Changes in facial expressivity (frequency, intensity and duration of Duchenne smiles) will be assessed during an emotional interview, using objective facial coding. |
Contacts
CONTACTVenkat Bhat
Outcome results
None listed