Take-home Functional Electrical Stimulation for MDD
Canada20 participantsStarted 2023-12-04
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a take-home electrical stimulation device for major depression and is focused on feasibility and safety rather than proving it works — what does that mean for what I might actually get out of participating, compared to a standard treatment my doctor already knows works?
2Since the trial is no longer actively recruiting, is there any chance I could still be considered for enrollment, or are there similar FES studies my doctor knows of that I could look into instead?
3Because this is a feasibility study, the safety profile of using this electrical stimulation device at home isn't fully established yet — what kinds of side effects or risks should I be aware of and discuss with my care team before considering something like this?
4Using a device at home without clinic supervision is a big part of what this trial is testing — how would my doctor assess whether I'm in a stable enough place to manage that kind of treatment independently?
5If I were in a study like this and the device didn't help or caused discomfort, would I still be able to switch to or continue standard antidepressant or therapy treatments at the same time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.