Transcranial Direct Current Stimulation for Depression

Overseen By Paul Thomas R&D Engineer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Soterix Medical

Must be taking: Antidepressants

Must not be taking: Benzodiazepines

Disqualifiers: Drug abuse, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: 5

Duration: 7 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for unipolar depression, a type of depression without mood swings. It combines transcranial direct current stimulation (tDCS), which uses mild electrical currents to stimulate the brain, with mindfulness exercises. The trial will compare the real tDCS treatment with a sham version to assess its effectiveness. It suits adults experiencing a major depressive episode for at least four weeks who are already on stable antidepressant medication. As an unphased trial, this study provides an opportunity to explore innovative treatments for depression.

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

The trial requires that any antidepressant medication you are taking must be stable for at least 30 days before the screening. However, you cannot participate if you are taking benzodiazepines.

What prior data suggests that transcranial direct current stimulation is safe for depression?

Research has shown that transcranial direct current stimulation (tDCS) has been tested for safety and effectiveness in treating depression. One study found that tDCS is safe and well-accepted when used at home with remote supervision. Another study confirmed that using tDCS at home is not only possible and safe but may also help people with depression. These findings suggest that tDCS is generally well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Direct Current Stimulation (tDCS) is unique because it offers a non-invasive method to potentially ease depression by applying a gentle electrical current to the brain, which may help improve mood and cognitive function. Unlike standard treatments for depression, such as medication or psychotherapy, tDCS is combined with mindfulness practices in this approach, adding a dual-action benefit that targets both the brain's electrical activity and mental well-being. Researchers are excited about this treatment because it could provide a safe, cost-effective option with fewer side effects compared to traditional methods like antidepressants, and it might offer quicker relief by enhancing the brain's natural healing processes.

What evidence suggests that transcranial direct current stimulation might be an effective treatment for depression?

Research has shown that transcranial direct current stimulation (tDCS) can help reduce depression symptoms. One study found that people who used tDCS at home for 10 weeks felt much better. This method proved safe and effective with remote monitoring. However, some research suggests that the long-term benefits might not differ significantly from not using tDCS. In this trial, participants will receive either active tDCS combined with mindfulness or sham tDCS with mindfulness to evaluate its effectiveness. Overall, tDCS appears promising for short-term relief from depression symptoms. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with unipolar depression. Specific eligibility details are not provided, but typically participants must meet diagnostic criteria for depression and be able to comply with study procedures.

Inclusion Criteria

Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview

QIDS-SR score >11 on all three days of screening week (Days 1,3, 7)

Scored at least 17 (inclusive) on the HDRS-17 at trial entry

Exclusion Criteria

History of clinically defined neurological disorder or insult that may impact participation in this study as determined by study physician

I did not improve after ECT or rTMS treatment.

Drug or alcohol abuse or dependence in the preceding 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) combined with mindfulness, delivered remotely via telemedicine

7 weeks

5 times per week (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Weekly assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study tests the effectiveness of transcranial direct current stimulation (tDCS) combined with mindfulness instruction versus a sham tDCS and mindfulness, delivered remotely via telemedicine to individuals with depression.

How Is the Trial Designed?

Group I: Active tDCS and Mindfulness Experimental Treatment 1 Intervention

Application of electrical stimulation to the brain non-invasively combined with mindfulness

Group II: Sham tDCS and Mindfulness Placebo Group 1 Intervention

Sham electrical stimulation and mindfulness

Who Is Running the Clinical Trial?

Soterix Medical

Lead Sponsor

Trials

12

Recruited

410+

Citations

1. nature.com nature.com/articles/s41591-024-03305-y

Home-based transcranial direct current stimulation ... In summary, a 10-week course of home-based active tDCS was associated with greater improvements in depressive symptoms, clinical response and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39433921/

a fully remote phase 2 randomized sham-controlled trial A 10-week home-based tDCS treatment with remote supervision in MDD showed high efficacy, acceptability and safety.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835422

Transcranial Electrical Stimulation in Treatment of ... Among tES modalities, tDCS was associated with a significant improvement in depressive symptoms among patients with DMC (SMD = −1.05; 95% CI, − ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022395625002018

6-month follow-up from randomised sham-controlled trial ... No significant differences were found in depressive symptoms between those who had continued tDCS with those who had not in the long term. Over half of ...

5. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2024.1458295/full

Cognitive potency and safety of tDCS treatment for major ... (2018) found no significant cognitive enhancement following active tDCS compared to sham for 12 cognitive outcomes across 478 MDD patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11439710

Cognitive potency and safety of tDCS treatment for major ... Results showed significant benefits following active tDCS compared to sham for the antidepressant effect [SMD: −0.77 (−1.44, −0.11)].

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666915325000320

Home-use transcranial direct current stimulation (tDCS) as ... The results of our study demonstrate that home-use tDCS is feasible, safe and might be effective for patients with depression.

8. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.20241088

Spaced Transcranial Direct Current Stimulation for ... In terms of clinical efficacy, the effects of tDCS were only modest, with improvements of approximately 30% and 40% in depression scores 3 and 6 ...