Electrical Stimulation for Depression

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Paralysis, Metallic implants, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 25

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Functional Electrical Stimulation (FES) on facial muscles can help treat major depressive disorder (MDD). FES sends small electrical pulses to the face, potentially improving mood. Participants will receive either active FES or a sham version, which provides a mild sensation without full stimulation. Individuals diagnosed with depression, currently experiencing a major depressive episode, and who have not tried more than two unsuccessful treatments might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for depression.

Do I have to stop taking my current medications for the trial?

No, you don't have to stop taking your current medications, but you must not change your medication regimen for at least 4 weeks before starting the study and during the trial.

What prior data suggests that Functional Electrical Stimulation is safe for treating major depressive disorder?

Research shows that functional electrical stimulation (FES) might help alleviate depression symptoms. Previous studies have explored FES for conditions like pain and stress, and some evidence suggests it can reduce anxiety and tension. A trial is planned to assess how well people with major depressive disorder (MDD) tolerate FES, monitoring for any side effects over 20 sessions in 4 weeks.

These studies have not reported specific data on serious side effects, suggesting that FES is generally well-tolerated. However, more research is needed to fully confirm its safety. If FES were unsafe, it would not advance in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Functional Electrical Stimulation (FES) is unique because it uses electrical impulses to directly stimulate the brain, offering a new approach to treating depression. Unlike traditional treatments like antidepressant medications or psychotherapy, which can take weeks to show effects, FES has the potential to provide faster relief by directly targeting brain activity. Researchers are excited about this treatment because it could provide an alternative for patients who don't respond to existing therapies, offering a more immediate and possibly more effective intervention. Additionally, the sham FES arm in the trial allows researchers to clearly determine the actual impact of the active stimulation, enhancing the understanding of its efficacy.

What evidence suggests that Functional Electrical Stimulation is effective for major depressive disorder?

Research has shown that Functional Electrical Stimulation (FES) on facial muscles might help ease symptoms of major depressive disorder (MDD). In this trial, participants will receive either Active FES or Sham FES. Studies suggest that FES can enhance positive facial expressions, potentially lifting mood and reducing depression. It gently stimulates facial muscles to encourage a happier expression, which could improve mood. Early findings indicate that this method might help reduce symptoms of anxiety, depression, and tension. Although more research is needed, these initial results are promising for those seeking new ways to treat depression. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with major depressive disorder (MDD) who haven't changed their depression treatment in the last 4 weeks. Participants should have had no more than two unsuccessful treatments for MDD and can't be pregnant, have metal implants near the face, facial paralysis, a history of manic or psychotic episodes, recent substance abuse (except nicotine/caffeine), or current suicidal plans.

Inclusion Criteria

I have major depression without psychosis and less than 3 treatments have failed.

I haven't changed my medication or treatment for my condition in the last 4 weeks.

Exclusion Criteria

Metallic implants or metal braces near the potential sites of electrical stimulation and any type of implanted electronic device

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

Current suicidal intent or plan as demonstrated by a score of ≥ 2 on MADRS item 10

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (phone)

Baseline

Initial assessment and baseline measurements before treatment begins

1 day

1 visit (in-person)

Treatment

Participants receive 20 FES sessions over 4 weeks

4 weeks

20 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Functional Electrical Stimulation (FES)

Trial Overview The study tests if stimulating facial muscles with Functional Electrical Stimulation (FES) helps treat MDD. It compares real FES to a fake version (Sham FES). The goal is also to create a method for patients to use this treatment at home.

How Is the Trial Designed?

Group I: Active FES Experimental Treatment 1 Intervention

300μs long charge-balanced biphasic pulses delivered at 40 Hz, with amplitudes in the range of 5-20 mA

Group II: Sham FES Placebo Group 1 Intervention

Sensory stimulation (below 8 mA)

Functional Electrical Stimulation (FES) is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Functional Electrical Stimulation for:

• Stroke rehabilitation
• Muscle paralysis
• Neurological disorders

Approved in United States as Functional Electrical Stimulation for:

• Stroke rehabilitation
• Spinal cord injuries
• Muscle weakness

Approved in Canada as Functional Electrical Stimulation for:

• Stroke rehabilitation
• Neurological disorders
• Muscle paralysis

Approved in Japan as Functional Electrical Stimulation for:

• Stroke rehabilitation
• Spinal cord injuries
• Muscle weakness

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12049065/

“Take-home” functional electrical stimulation for depression The proposed study will develop a viable prototype for a “take-home” FES device and perform a proof-of-concept feasibility trial for participants with MDD.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/PMC12049065

"Take-home" functional electrical stimulation for depression The existing evidence suggests that FES of the facial muscles can reduce MDD symptoms by enhancing positive facial feedback and altering the ...

3. mdpi.com mdpi.com/1424-8220/25/7/2133

Impact of Electrical Stimulation on Mental Stress ... The results indicate that electrical stimulation has the potential to alleviate symptoms of anxiety, depression, and tension.

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01187-8

Manipulating facial musculature with functional electrical ... This article provides a conceptual overview of functional electrical stimulation (FES), a novel neuromodulation-based treatment modality that can be ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2211034823006156

Electrical stimulation therapy for pain and related ... This study aims to analyze and discuss the efficacy of various EST treatments in alleviating pain among MS patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10616008/

Do Electrical Stimulation Devices Reduce Pain and ... Ten of 13 reviewed forms of ES have only limited quality evidence for clinically significant reduction of pain or improvement of function across different ...

7. clinicaltrial.be clinicaltrial.be/en/details/425552?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Take-home Functional Electrical Stimulation for MDD - Cli... The trial will evaluate the feasibility, tolerability, and safety of 20 FES sessions (over 4 weeks) for MDD. Additionally, data on the ...

8. aetna.com aetna.com/cpb/medical/data/600_699/0677.html

Functional Electrical Stimulation and Neuromuscular ... This Clinical Policy Bulletin addresses functional electrical stimulation and neuromuscular electrical stimulation.