NCT06261177Active, not recruiting
Take-home Functional Electrical Stimulation for MDD
"Take-Home" Functional Electrical Stimulation for Depression: Prototype Development and Proof of Concept Clinical Trial
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
The purpose of this study is to learn whether Functional Electrical Stimulation (FES) of the facial muscles is effective in treating major depressive disorder (MDD) and to develop a model for take-home delivery.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 4 Jan 2024
- Start date
- 4 Dec 2023
- Primary completion date
- Feb 2028
- Lead sponsor
- Unity Health Toronto
- Diseases
- Depression
- NCT number
- NCT06261177
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 4 Dec 2023 to the primary completion date, Feb 2028
- 1 site in 1 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
- 1\. Paralysis of facial nerves
- 2\. Metallic implants or metal braces near the potential sites of electrical stimulation and any type of implanted electronic device
- 3\. Current fibromyalgia or currently receiving or have received repetitive transcranial magnetic stimulation (rTMS) within the last month (28 days) before screening
- 4\. Past or current symptoms of mania, hypomania, mixed episodes, psychotic disorders, active substance abuse, or dependence (excluding nicotine and caffeine) which will be confirmed on the MINI done by a trained research assistant
- 5\. Current suicidal intent or plan as demonstrated by a score of ≥ 2 on MADRS item 10
Who the study is looking for
- Meet the DSM-5 criteria for unipolar MDD with a current major depressive episode (MDE) without psychotic features, with ≤ 2 failed treatment trials (non-treatment-resistant depression), as determined by a physician and validated by a MINI done by a trained research assistant
- 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, during the 20-session treatment period, and the 4-week post-treatment observation period. This will be established through self-report, in combination with the Antidepressant Treatment History Form (ATHF) form filled out by the participant.
- Men and non-pregnant women aged \> 18 years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.