NCT06261177

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

January 4, 2024

Last Update Submit

February 14, 2024

Conditions

MDD

Keywords

Major Depressive DisorderTake-home treatmentFunctional Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

  • Feasibility of the FES for MDD

    The feasibility outcome defined as recruitment dropout, data completion, and protocol compliance rates.

    4 weeks

  • Tolerability and safety of the FES for MDD

    The tolerability and safety outcomes defined as the number and nature of adverse events and serious adverse events, to evaluate patient experience with the FES

    4 weeks

Secondary Outcomes (5)

  • Improvement in symptoms of depression-17-item Hamilton Depression Rating Scale (HAM-D-17)

    4 weeks

  • Improvement in symptoms of depression-16-Item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16)

    4 week

  • Improvement in symptoms of anxiety- General Anxiety Disorder (GAD-7)

    4 week

  • Improvement in well-being-World Health Organization-5 Well-Being Index (WHO-5)

    4 week

  • Improvement in sleep quality- Pittsburgh Sleep Quality Index (PSQI)

    4 week

Study Arms (2)

Active FES

EXPERIMENTAL

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

Device: Functional Electrical Stimulation (FES)

Sham FES

SHAM COMPARATOR

Sensory stimulation (below 8 mA)

Device: Sham FES

Interventions

Functional Electrical Stimulation (FES)DEVICE

45 mins per day for the duration of 4 weeks (20 sessions).

Active FES
Sham FESDEVICE

Sham FES

Sham FES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the DSM-5 criteria for unipolar MDD with a current major depressive episode (MDE) without psychotic features, with ≤ 2 failed treatment trials (non-treatment-resistant depression), as determined by a physician and validated by a MINI done by a trained research assistant
  • 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.
  • Men and non-pregnant women aged \> 18 years

You may not qualify if:

  • \. Paralysis of facial nerves
  • \. Metallic implants or metal braces near the potential sites of electrical stimulation and any type of implanted electronic device
  • \. Current fibromyalgia or currently receiving or have received repetitive transcranial magnetic stimulation (rTMS) within the last month (28 days) before screening
  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Gholamali Nezhad F, Tassone VK, Demchenko I, Chen JXM, Iwasa SN, Martin J, Desai N, Naguib HE, Popovic MR, Bhat V. "Take-home" functional electrical stimulation for depression: protocol for a prototype development and proof of concept randomized controlled trial. Pilot Feasibility Stud. 2025 May 3;11(1):60. doi: 10.1186/s40814-025-01642-4.

    PMID: 40319334DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2024

First Posted

February 15, 2024

Study Start

December 4, 2023

Primary Completion

December 1, 2024

Study Completion

March 1, 2025

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)