Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
20 participants
INTERVENTIONAL
2023-12-04
2025-03-31
Brief Summary
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Detailed Description
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This is a single-site, pilot, double-blind, randomized, sham-controlled clinical trial. The trial will evaluate the feasibility, tolerability, and safety of 20 FES sessions (over 4 weeks) for MDD. Additionally, data on the preliminary therapeutic effects of 20 FES sessions for the symptoms of MDD and associated anxiety, quality of life, and sleep will be collected.
Eligible participants enrolled in this clinical trial will have a total of 28 visits. There will be 1 screening visit which will take place over the phone, 3 on-site visits (including 1 mask development visit, 1 mask delivery visit, and the last follow-up visit), and 24 Online visits (to take place over videoconference on the Zoom platform); One baseline Visit, 20 days of the FES treatment sessions, and three post-stimulation visits.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active FES
300μs long charge-balanced biphasic pulses delivered at 40 Hz, with amplitudes in the range of 5-20 mA
Functional Electrical Stimulation (FES)
45 mins per day for the duration of 4 weeks (20 sessions).
Sham FES
Sensory stimulation (below 8 mA)
Sham FES
Sham FES
Interventions
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Functional Electrical Stimulation (FES)
45 mins per day for the duration of 4 weeks (20 sessions).
Sham FES
Sham FES
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Men and non-pregnant women aged \> 18 years
Exclusion Criteria
2\. Metallic implants or metal braces near the potential sites of electrical stimulation and any type of implanted electronic device
3\. Current fibromyalgia or currently receiving or have received repetitive transcranial magnetic stimulation (rTMS) within the last month (28 days) before screening
4\. 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
5\. Current suicidal intent or plan as demonstrated by a score of ≥ 2 on MADRS item 10
18 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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22-175
Identifier Type: -
Identifier Source: org_study_id
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