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Active, Not Recruiting

NCT Number: NCT06261177

Take-home Functional Electrical Stimulation for MDD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

MDD Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, Canada

About this study

A potential novel intervention for major depressive disorder (MDD) is bilateral functional electrical stimulation (FES) of the facial muscles. The portable FES stimulator delivers electrical current to excitable tissues. Based on the preliminary work, FES can elevate mood in healthy subjects and reduce anxiety symptoms in MDD patients. The proposed study will develop a viable prototype for a "take-home" FES device and evaluate the feasibility, tolerability, and safety of FES for participants with MDD.

This is a single-site, pilot, double-blind, randomized, sham-controlled clinical trial. The trial will evaluate the feasibility, tolerability, and safety of 20 FES sessions (over 4 weeks) for MDD. Additionally, data on the preliminary therapeutic effects of 20 FES sessions for the symptoms of MDD and associated anxiety, quality of life, and sleep will be collected.

Eligible participants enrolled in this clinical trial will have a total of 28 visits. There will be 1 screening visit which will take place over the phone, 3 on-site visits (including 1 mask development visit, 1 mask delivery visit, and the last follow-up visit), and 24 Online visits (to take place over videoconference on the Zoom platform); One baseline Visit, 20 days of the FES treatment sessions, and three post-stimulation visits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 1. Paralysis of facial nerves
  • Metallic implants or metal braces near the potential sites of electrical stimulation and any type of implanted electronic device
  • Current fibromyalgia or currently receiving or have received repetitive transcranial magnetic stimulation (rTMS) within the last month (28 days) before screening
  • 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
  • Current suicidal intent or plan as demonstrated by a score of ≥ 2 on MADRS item 10

Treatment and study plan

Functional Electrical Stimulation (FES)

Device

45 mins per day for the duration of 4 weeks (20 sessions).

Sham FES

Device

Sham FES

Primary outcomes

  1. Feasibility of the FES for MDD

    Time frame: 4 weeks

    The feasibility outcome defined as recruitment dropout, data completion, and protocol compliance rates.

  2. Tolerability and safety of the FES for MDD

    Time frame: 4 weeks

    The tolerability and safety outcomes defined as the number and nature of adverse events and serious adverse events, to evaluate patient experience with the FES

Secondary outcomes

  1. Improvement in symptoms of depression-17-item Hamilton Depression Rating Scale (HAM-D-17)

    Time frame: 4 weeks

    The is a semi-structured, clinician-administered interview that has been well-validated in measuring the presence and severity of depression. This scale will be administered at baseline, at the end of each treatment week, and at each follow-up visit. Decrease in total scores defined as improvement in depressive symptoms.

  2. Improvement in symptoms of depression-16-Item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16)

    Time frame: 4 week

    QIDS-SR-16 is a self-rated survey that has been psychometrically validated to screen for depression, using the diagnostic criteria for MDD from the DSM-IV. This self-report measure will be done at baseline, during each treatment visit, and at each follow-up visit. Decrease in total scores defined as improvement in depressive symptoms.

  3. Improvement in symptoms of anxiety- General Anxiety Disorder (GAD-7)

    Time frame: 4 week

    The GAD-7 is a self-rated questionnaire for assessing generalized anxiety disorder and its severity, and will be done at baseline, during treatment visits 5, 10, 15, and 20, and at each follow-up visit. Items are ranked on a 4-point scale from 0 (not at all sure) to 3 (nearly every day), providing a total severity score from 0 to 21.

  4. Improvement in well-being-World Health Organization-5 Well-Being Index (WHO-5)

    Time frame: 4 week

    The WHO-5 Well-Being Index is a self-rated scale that is designed to measure well-being over the past two weeks. This self-report measure will be done at baseline, during treatment visits 5, 10, 15, and 20, and at each follow-up visit. Participants will rate the frequency or consistency of each positive feeling on a 6-point scale from 0 (at no time) to 5 (all of the time). The sum of scores from the five items will then be multiplied by 4, representing the participant's perceived quality of life as a percentage.

  5. Improvement in sleep quality- Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 4 week

    The PSQI is a self-rated scale that measure sleep habits and quality. This self-report measure will be done at baseline, during treatment visits 5, 10, 15, and 20, and at each follow-up visit. This scale is broken up into seven components that assess sleep quality, latency, duration, efficiency, disturbances, medication use, and daytime dysfunction. The sum of scores from all seven components will generate a global score of 0-21, with higher scores indicating lower sleep quality.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

"Take-Home" Functional Electrical Stimulation for Depression: Prototype Development and Proof of Concept Clinical Trial

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Feb 15, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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