Functional Electrical Stimulation for MDD
4. juni 2026 oppdatert av: 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).
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Venkat Bhat
- Telefonnummer: 76404 416-360-4000
- E-post: Venkat.Bhat@unityhealth.to
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
Patients will be included if they:
- 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.
- 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.
- Have an MDD diagnosis as confirmed by the MADRS score of ≥7.
- Age group between 18 and 70 years of age
Exclusion Criteria:
Patients will be excluded if they:
- History of epilepsy or seizures.
- Damage or dysfunction of facial nerves.
- Metallic orthopedic implants in the mouth (e.g., plates or screws).
- Current fibromyalgia or currently receiving or have received rTMS within the last 28 days before the screening.
- 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.
- 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.
- Current suicidal intent or plan as demonstrated by a score of ≥4 on MADRS item 10.
- Unable to understand instructions in English.
- Unable to produce "Duchenne marker" expression with FES, secondary to any type of neurological condition or previous botulinum toxin treatments of facial muscles.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Active FES
Functional Electrical Stimulation (FES) will be administered to four facial muscles involved in smiling, with two muscles targeted on each side of the face.
Electrodes will be placed over the target muscles, and stimulation will be delivered using standard muscle-activation settings.
|
Once per day for the duration of 4 weeks.
Total of 20 sessions (each session lasts 60 mins)
|
|
Sham-komparator: Sham FES
Sham Functional Electrical Stimulation (FES) will be administered using the same electrode placement and session schedule as the active FES arm.
Stimulation will be delivered at a low sensory intensity range of 1-8 mA, sufficient for participants to feel the stimulation, while other parameters will remain the same as in the active arm.
Sham stimulation will be delivered in a non-Duchenne smile pattern.
|
Once per day for the duration of 4 weeks.
Total of 20 sessions (each session lasts 60 mins)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
25. mai 2026
Primær fullføring (Antatt)
20. april 2028
Studiet fullført (Antatt)
30. mars 2029
Datoer for studieregistrering
Først innsendt
25. mai 2026
Først innsendt som oppfylte QC-kriteriene
2. juni 2026
Først lagt ut (Faktiske)
5. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juni 2026
Sist bekreftet
1. mars 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 24-155
- WI4 179978 (Annet stipend/finansieringsnummer: Canadian Institutes of Health Research (CIHR))
Plan for individuelle deltakerdata (IPD)
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