Functional Electrical Stimulation for MDD
ConditionMDD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUnity Health Toronto
About this 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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Functional Electrical Stimulation (FES)
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov