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Functional Electrical Stimulation for MDD

2. juni 2026 opdateret af: Unity Health Toronto

Functional Electrical Stimulation for Major Depressive Disorder: A Pilot Randomized Control Trial

This study aims to determine whether Functional Electrical Stimulation (FES) of the facial muscles is a safe and effective treatment for major depressive disorder (MDD).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A potential new treatment for Major Depressive Disorder (MDD) involves using a Functional Electrical Stimulation (FES) device to stimulate specific facial muscles. By targeting muscles related to smile patterns, FES has shown promise in improving emotional control and boosting mood. This project aims to address a critical need for innovative treatments for MDD, especially since 30% of MDD patients do not respond to traditional treatments.

This is a single-site clinical trial that is double-blind, randomized, and sham-controlled, involving 20 sessions of FES over four weeks. The trial will assess the effectiveness, safety, and tolerability of FES for individuals with mild-to-moderate major depressive episode (MDE) and a primary diagnosis of MDD.

Participants in the study will have a total of 26 visits: one screening and one baseline visit (both conducted by phone), followed by 20 on-site intervention visits over four weeks (one sessions per day). After the treatment, there will also be four follow-up visits over the phone to check how long the effects of the FES treatment last.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

Patients will be included if they:

  1. Meet the DSM-5 criteria for unipolar MDD with a current MDE without psychotic features, with ≤ 2 failed treatment trials (non-treatment-resistant depression), validated by MINI done by a trained research assistant.
  2. 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, and have no plan to change them during the 20-session treatment period (14 days), and the 4-week post-treatment observation period. This will be established through self-report, in combination with the ATHF filled out by the participant.
  3. Have an MDD diagnosis as confirmed by the MADRS score of ≥7.
  4. Age group between 18 and 70 years of age

Exclusion Criteria:

Patients will be excluded if they:

  1. History of epilepsy or seizures.
  2. Damage or dysfunction of facial nerves.
  3. Metallic orthopedic implants in the mouth (e.g., plates or screws).
  4. Current fibromyalgia or currently receiving or have received rTMS within the last 28 days before the screening.
  5. History of treatment-resistant depression (TRD) with history of ECT, Magnetic Seizure Therapy, Intravenous Ketamine use in the past or failure of >2 antidepressant treatments of adequate duration and dose during the current episode.
  6. Past or current symptoms of mania, hypomania, mixed episodes, psychotic disorders, obsessive-compulsive disorder, post-traumatic stress disorder, active substance abuse or dependence (excluding nicotine and caffeine), neurodegenerative disease, or dementia. This will be confirmed on the MINI (77) administered by a trained research assistant.
  7. Current suicidal intent or plan as demonstrated by a score of ≥4 on MADRS item 10.
  8. Unable to understand instructions in English.
  9. Unable to produce "Duchenne marker" expression with FES, secondary to any type of neurological condition or previous botulinum toxin treatments of facial muscles.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Active FES

Participants in the active group will receive FES on four facial muscles involved in smiling (two on each side of the face). Electrodes will be placed on these muscles, and stimulation will be delivered using an FES device with standard muscle-activation settings. The stimulation will follow repeated cycles of 15 seconds ON and 15 seconds OFF.

While receiving FES, participants will watch positive or comedy videos. They will also be encouraged to voluntarily produce a natural smile during stimulation. After each smile, participants will press a button to confirm they followed the instruction.
Enhed: Functional Electrical Stimulation (FES)
Once per day for the duration of 4 weeks. Total of 20 sessions (each session lasts 60 mins)
Sham-komparator: Sham FES
Participants recruited to the sham arm will also receive FES of the facial muscles in the same setup as the experimental group, but with only sensory stimulation (in the range of 1-8 mA stimulation - just enough to feel the stimulation, with other parameters the same as active arm) and in a non-Duchenne smile pattern.
Enhed: Functional Electrical Stimulation (FES)
Once per day for the duration of 4 weeks. Total of 20 sessions (each session lasts 60 mins)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy of FES: Change in Depression Severity
Tidsramme: 4 weeks of Intervention, 4 weeks of follow-up
Change in depression severity measured using the 17-item Hamilton Depression Rating Scale (HAM-D-17). Scores range from 0 to 52, with higher scores indicating more severe depressive symptoms.
4 weeks of Intervention, 4 weeks of follow-up
Tolerability of FES
Tidsramme: 4 weeks of Intervention, 4 weeks of follow-up
The overall dropout and protocol compliance rates will be assessed.
4 weeks of Intervention, 4 weeks of follow-up
FES safety
Tidsramme: 4 weeks of Intervention, 4 weeks of follow-up
The number and nature of adverse events will be assessed
4 weeks of Intervention, 4 weeks of follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Anxiety Symptoms
Tidsramme: 4 weeks of Intervention, 4 weeks of follow-up
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
4 weeks of Intervention, 4 weeks of follow-up
Change in Well-Being
Tidsramme: 4 weeks of Intervention, 4 weeks of follow-up
Well-being will be assessed using the World Health Organization-Five Well-Being Index. Raw total scores range from 0 to 25, with higher scores indicating better well-being.
4 weeks of Intervention, 4 weeks of follow-up
Change in Sleep Quality
Tidsramme: 4 weeks of Intervention, 4 weeks of follow-up
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.
4 weeks of Intervention, 4 weeks of follow-up
Response and Remission Rate
Tidsramme: 4 weeks of Intervention, 4 weeks of follow-up
Response and Remission will be assessed using the 17-item Hamilton Depression Rating Scale. Total scores on the 17-item Hamilton Depression Rating Scale range from 0 to 52, with higher scores indicating greater depression symptom severity.
4 weeks of Intervention, 4 weeks of follow-up
Changes in Facial Expressivity
Tidsramme: 4 weeks of Intervention
Changes in facial expressivity (frequency, intensity and duration of Duchenne smiles) will be assessed during an emotional interview, using objective facial coding.
4 weeks of Intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Unity Health Toronto

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. maj 2026

Primær færdiggørelse (Anslået)

20. april 2028

Studieafslutning (Anslået)

30. marts 2029

Datoer for studieregistrering

Først indsendt

25. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 24-155
  • WI4 179978 (Andet bevillings-/finansieringsnummer: Canadian Institutes of Health Research (CIHR))

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med MDD

Kliniske forsøg med Functional Electrical Stimulation (FES)

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