Electrical Stimulation for Depression

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Paralysis, Metallic implants, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 25

Duration: 4 weeks

20 Participants Needed

Trial Summary

What is the purpose of this 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.

Eligibility Criteria

This trial is for adults over 18 with major depressive disorder (MDD) who haven't changed their depression treatment in the last 4 weeks. Participants should have had no more than two unsuccessful treatments for MDD and can't be pregnant, have metal implants near the face, facial paralysis, a history of manic or psychotic episodes, recent substance abuse (except nicotine/caffeine), or current suicidal plans.

Inclusion Criteria

I have major depression without psychosis and less than 3 treatments have failed.

I haven't changed my medication or treatment for my condition in the last 4 weeks.

Exclusion Criteria

Metallic implants or metal braces near the potential sites of electrical stimulation and any type of implanted electronic device

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (phone)

Baseline

Initial assessment and baseline measurements before treatment begins

1 day

1 visit (in-person)

Treatment

Participants receive 20 FES sessions over 4 weeks

4 weeks

20 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

3 visits (in-person)

Treatment Details

Interventions

• Functional Electrical Stimulation (FES)

Trial Overview The study tests if stimulating facial muscles with Functional Electrical Stimulation (FES) helps treat MDD. It compares real FES to a fake version (Sham FES). The goal is also to create a method for patients to use this treatment at home.

Participant Groups

Group I: Active FES Experimental Treatment 1 Intervention

300μs long charge-balanced biphasic pulses delivered at 40 Hz, with amplitudes in the range of 5-20 mA

Group II: Sham FES Placebo Group 1 Intervention

Sensory stimulation (below 8 mA)

Functional Electrical Stimulation (FES) is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Functional Electrical Stimulation for:

• Stroke rehabilitation
• Muscle paralysis
• Neurological disorders

Approved in United States as Functional Electrical Stimulation for:

• Stroke rehabilitation
• Spinal cord injuries
• Muscle weakness

Approved in Canada as Functional Electrical Stimulation for:

• Stroke rehabilitation
• Neurological disorders
• Muscle paralysis

Approved in Japan as Functional Electrical Stimulation for:

• Stroke rehabilitation
• Spinal cord injuries
• Muscle weakness

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+