MDD Clinical Trial - Take-home Functional Electrical Stimulation for MDD

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06261177
Study type	Interventional
Source	Unity Health Toronto
Contact
Status	Active, not recruiting
Phase	N/A
Start date	December 4, 2023
Completion date	March 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04482296` - Effect of Zinc Supplementation on Depression in SSRI-treated Major Depressive Disorder Patients	N/A
Recruiting	`NCT04071886` - Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study	N/A
Completed	`NCT04076644` - Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder	N/A
Completed	`NCT05528315` - SAD/MAD of ABX-002-1902 Investigating the Safety, Pharmacokinetics/Pharmacodynamics of in Healthy Subjects	Phase 1
Recruiting	`NCT05437588` - Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents	N/A
Recruiting	`NCT06095778` - rTMS Therapy for Treatment-Resistant Depression With Different Targets Guided by pBFS	N/A
Active, not recruiting	`NCT05657691` - Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD)	Phase 2
Completed	`NCT02013609` - Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment	Phase 3
Completed	`NCT02339285` - Transcranial Alternating Current Stimulation for Major Depressive Disorder	N/A
Recruiting	`NCT03971305` - A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL
Recruiting	`NCT05169346` - Neurofeedback to Treat Depression	N/A
Completed	`NCT01344733` - A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD)	N/A
Completed	`NCT04268316` - Virtual Reality Behavioral Activation: An Intervention for Major Depressive Disorder	N/A
Active, not recruiting	`NCT01557946` - Glutamatergic and GABAergic Mediators of Antidepressant Response in Major Depression	Phase 2
Recruiting	`NCT01501812` - Evaluation of Generalization Paradigm Patterns Among Different Psychiatric Disorders	N/A
Completed	`NCT04880460` - Effect of Magnesium Supplementation in Selective Serotonin Reuptake Inhibitors Treated Major Depressive Disorder Patients	Phase 2
Completed	`NCT04226352` - Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder	Phase 1
Recruiting	`NCT03754712` - Effect of Vitamin D Administration Along With SSRIs in Patients With Major Depressive Disorder	N/A
Recruiting	`NCT02669030` - A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia	Phase 4
Completed	`NCT03994081` - Mechanism of Action of tACS for the Treatment of MDD	N/A