Take-home Functional Electrical Stimulation for MDD

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: MDD
• Intervention / Treatment: Device: Functional Electrical Stimulation (FES); Device: Sham FES

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. 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.
3. Men and non-pregnant women aged > 18 years

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active FES; 300μs long charge-balanced biphasic pulses delivered at 40 Hz, with amplitudes in the range of 5-20 mA	Device: Functional Electrical Stimulation (FES); 45 mins per day for the duration of 4 weeks (20 sessions).
Sham Comparator: Sham FES; Sensory stimulation (below 8 mA)	Device: Sham FES; Sham FES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the FES for MDD	The feasibility outcome defined as recruitment dropout, data completion, and protocol compliance rates.	4 weeks
Tolerability and safety of the FES for MDD	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	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in symptoms of depression-17-item Hamilton Depression Rating Scale (HAM-D-17)	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.	4 weeks
Improvement in symptoms of depression-16-Item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16)	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.	4 week
Improvement in symptoms of anxiety- General Anxiety Disorder (GAD-7)	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 week
Improvement in well-being-World Health Organization-5 Well-Being Index (WHO-5)	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.	4 week
Improvement in sleep quality- Pittsburgh Sleep Quality Index (PSQI)	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.	4 week

Collaborators and Investigators

• Sponsor: Unity Health Toronto

Publications and helpful links

General Publications

• Gholamali Nezhad F, Tassone VK, Demchenko I, Chen JXM, Iwasa SN, Martin J, Desai N, Naguib HE, Popovic MR, Bhat V. "Take-home" functional electrical stimulation for depression: protocol for a prototype development and proof of concept randomized controlled trial. Pilot Feasibility Stud. 2025 May 3;11(1):60. doi: 10.1186/s40814-025-01642-4.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Major Depressive Disorder; Functional Electrical Stimulation; Take-home treatment
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 22-175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No