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Behavioural Intervention

Electrical Stimulation for Depression

N/A
Waitlist Available
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Paralysis of facial nerves
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 week

Summary

This trial aims to see if using electrical stimulation on facial muscles can help treat major depressive disorder. They also want to create a method for patients to use this treatment at home.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects of FES may include discomfort at the stimulation site, muscle twitching, headache, or skin irritation. Since it's non-invasive and localized to facial muscles, severe side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I haven't changed my medication or treatment for my condition in the last 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have paralysis in the nerves of my face.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of the FES for MDD
Tolerability and safety of the FES for MDD
Secondary study objectives
Improvement in sleep quality- Pittsburgh Sleep Quality Index (PSQI)
Improvement in symptoms of anxiety- General Anxiety Disorder (GAD-7)
Improvement in symptoms of depression-16-Item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16)
+2 more

Trial Design

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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Functional Electrical Stimulation (FES)
2017
N/A
~100

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
556 Previous Clinical Trials
454,386 Total Patients Enrolled
18 Trials studying Depression
3,105 Patients Enrolled for Depression
~0 spots leftby Dec 2024
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