NCT06261177

Take-home Functional Electrical Stimulation for MDD

"Take-Home" Functional Electrical Stimulation for Depression: Prototype Development and Proof of Concept Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• MDD

Interventions

Type	Name	Description
DEVICE	Functional Electrical Stimulation (FES)	45 mins per day for the duration of 4 weeks (20 sessions).
DEVICE	Sham FES	Sham FES

Timeline

• Start date: 2023-12-04
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2024-02-15
• Last updated: 2024-02-15

Locations

1 site across 1 country: Canada