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Behavioural Intervention

Active FES 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 week

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 week

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of the FES for MDD

Tolerability and safety of the FES for MDD

Secondary outcome measures

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor

538 Previous Clinical Trials

447,843 Total Patients Enrolled

17 Trials studying Depression

3,075 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary objectives of this clinical trial?

"The primary objective of this clinical study, which spans a duration of 4 weeks, is to assess the tolerability and safety of FES for Major Depressive Disorder (MDD). Secondary goals encompass enhancements in Generalized Anxiety Disorder symptoms using the GAD-7 questionnaire at various time points throughout the trial. Furthermore, improvements in overall well-being will be evaluated through the WHO-5 Well-Being Index scale. Lastly, changes in depressive symptomatology will be measured utilizing the HAM-D-17 scale across treatment sessions and follow-up visits."

Answered by AI

Are researchers currently enrolling participants for this study?

"As per information from clinicaltrials.gov, this particular trial is no longer seeking participants. It was initially listed on 12/4/2023 and last modified on 2/14/2024. Despite this trial not being open for recruitment, there are currently 313 other trials actively searching for eligible candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Take-home Functional Electrical Stimulation for MDD

2023. "Take-home Functional Electrical Stimulation for MDD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06261177.

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