Take-home Functional Electrical Stimulation for MDD

Not Applicable

Active, not recruiting

• Conditions: MDD
• Interventions: Device: Functional Electrical Stimulation (FES); Device: Sham FES

• Registration Number: NCT06261177
• Lead Sponsor: Unity Health Toronto

Brief 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.

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 Timeline

• Study Start: 2023-12-04
• Study First Submitted: 2024-01-04
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-14
• Last Update Submitted: 2024-02-14
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active FES	Functional Electrical Stimulation (FES)	300μs long charge-balanced biphasic pulses delivered at 40 Hz, with amplitudes in the range of 5-20 mA
Sham FES	Sham FES	Sensory stimulation (below 8 mA)

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada