Electrical Stimulation for Depression

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Unity Health Toronto

No Placebo Group

Approved in 4 Jurisdictions

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 am over 18 years old and not pregnant.

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

+2 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active FESExperimental Treatment1 Intervention

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

Group II: Sham FESPlacebo Group1 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: