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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Functional Electrical Stimulation (FES)
DeviceOnce per day for the duration of 4 weeks. Total of 20 sessions (each session lasts 60 mins)
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active FESExperimental treatment 1 intervention
Group B: Sham FESSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of FES: Change in Depression Severity
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.
Time frame
4 weeks of Intervention, 4 weeks of follow-up2
Tolerability of FES
The overall dropout and protocol compliance rates will be assessed.
Time frame
4 weeks of Intervention, 4 weeks of follow-up3
FES safety
The number and nature of adverse events will be assessed
Time frame
4 weeks of Intervention, 4 weeks of follow-upSecondary outcomes
1
Change in Anxiety Symptoms
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.
Time frame
4 weeks of Intervention, 4 weeks of follow-up2
Change in Well-Being
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.
Time frame
4 weeks of Intervention, 4 weeks of follow-up3
Change in Sleep Quality
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.
Time frame
4 weeks of Intervention, 4 weeks of follow-up4
Response and Remission Rate
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.
Time frame
4 weeks of Intervention, 4 weeks of follow-upLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: