Clinical trial NCT06261177: Take-home Functional Electrical Stimulation for MDD
Official title: "Take-Home" Functional Electrical Stimulation for Depression: Prototype Development and Proof of Concept Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: MDD
Keywords: Major Depressive Disorder
Take-home treatment
Functional Electrical Stimulation
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the FES for MDD
timeFrame: 4 weeks
measure: Tolerability and safety of the FES for MDD
timeFrame: 4 weeks
Secondary outcomes:
measure: Improvement in symptoms of depression-17-item Hamilton Depression Rating Scale (HAM-D-17)
timeFrame: 4 weeks
measure: Improvement in symptoms of depression-16-Item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16)
timeFrame: 4 week
measure: Improvement in symptoms of anxiety- General Anxiety Disorder (GAD-7)
timeFrame: 4 week
measure: Improvement in well-being-World Health Organization-5 Well-Being Index (WHO-5)
timeFrame: 4 week
measure: Improvement in sleep quality- Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 week
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References: