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MDDNCT06261177

Take-home Functional Electrical Stimulation for MDD

A study testing Functional Electrical Stimulation (FES) in people with MDD, run by Unity Health Toronto at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MDD
What is being tested?
Functional Electrical Stimulation (FES)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteCanada
Study dates
4 Dec 2023to Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Michael's Hospital

    Toronto, Ontario

Other trials in Canada

About this study

Official title: "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.

Read the 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.

Conditions
MDD
Being tested
Functional Electrical Stimulation (FES), Sham FES
Keywords
Major Depressive Disorder, Take-home treatment, Functional Electrical Stimulation
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Electrical Stimulation (FES)Device

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

  • Sham FESDevice

    Sham FES

Study groups in NCT06261177
Study groupRoleWhat they receive
Active FESExperimental300μs long charge-balanced biphasic pulses delivered at 40 Hz, with amplitudes in the range of 5-20 mA
Receives: Device: Functional Electrical Stimulation (FES)
Sham FESSham comparatorSensory stimulation (below 8 mA)
Receives: Device: Sham FES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the FES for MDD

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

    Measured: 4 weeks

  2. 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

    Measured: 4 weeks

Secondary outcomes (5)

  1. 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.

    Measured: 4 weeks

  2. 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.

    Measured: 4 week

  3. 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.

    Measured: 4 week

  4. 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.

    Measured: 4 week

  5. 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.

    Measured: 4 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2024
  2. Study start4 Dec 2023
  3. Primary completionFeb 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06261177
Sponsor's protocol ID
22-175
Status last verified
May 2026
First submitted
4 Jan 2024
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 40319334

Questions about this trial

What is this clinical trial studying?

A study testing Functional Electrical Stimulation (FES) in people with MDD, run by Unity Health Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the FES for MDD (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06261177, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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