tDCS for Depression

(REACH-tDCS Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sooma Medical Inc

Must be taking: Antidepressants

Must not be taking: Esketamine, Ketamine, others

Disqualifiers: Mania, Psychosis, Epilepsy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a home-based brain stimulation treatment called tDCS (transcranial direct current stimulation) is safe and effective for individuals with Major Depressive Disorder. Participants will use the device at home and report their progress through video interviews and self-reports over a 10-week period. The trial includes two groups: one receiving the actual treatment and the other receiving a sham (placebo) treatment. It suits individuals diagnosed with Major Depressive Disorder who are already on antidepressants and can use a smartphone or similar device. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options.

Do I need to stop taking my current medications to join the trial?

The trial does not require you to stop taking your current antidepressant medications. In fact, participants need to be on a stable regimen of antidepressants to join the study.

What prior data suggests that this tDCS treatment is safe for depression?

Studies have shown that transcranial direct current stimulation (tDCS), a type of brain stimulation, is generally safe. Research indicates that using tDCS at home is both practical and safe for people with depression.

In one study, tDCS caused only minor side effects and was well tolerated, meaning it didn't cause major problems for patients. Another study found no significant differences in dropout rates or side effects between those receiving real tDCS and those receiving a sham (fake) treatment.

These findings suggest that tDCS is a safe option for treating depression, with few negative effects reported. However, as with any treatment, monitoring for potential side effects is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tDCS for depression because it offers a non-invasive and drug-free alternative to traditional treatments like antidepressants and psychotherapy. Unlike medications, which can take weeks to work and may have side effects, tDCS uses mild electrical currents to stimulate specific areas of the brain potentially leading to faster improvements in mood. This method could provide a new option for patients who haven’t found relief with standard treatments or those looking to avoid medication side effects.

What evidence suggests that tDCS is effective for Major Depressive Disorder?

Research has shown that transcranial direct current stimulation (tDCS) can help reduce symptoms of major depression. In this trial, participants will receive either active tDCS or a sham treatment. One study found that people who used active tDCS at home for 10 weeks showed more improvement in their depression symptoms than those who received a fake treatment. Another study reported a significant improvement in patients' depression scores, with an average drop of 9.41 points on a standard depression scale. However, some reports indicate that the benefits of tDCS can be modest, with about 30% to 40% improvement in depression scores. These findings suggest that tDCS could be a promising option for treating depression, though results can vary. ^{3 4 6 7 8}

Who Is on the Research Team?

Christopher Reist, M.D.

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for individuals with Major Depressive Disorder who are looking for a noninvasive treatment. Participants will use the Sooma tDCS device at home and must be comfortable with video interviews and self-reporting. Specific inclusion or exclusion criteria details were not provided.

Inclusion Criteria

I am between 22 and 70 years old.

Allow communication between investigators/study staff and healthcare provider

Provide contact information for at least two adult persons within a 60-minute drive

Exclusion Criteria

Disorders impairing ability to complete study questionnaires

Alcohol use disorder or substance use disorder in the past 12 months

Current state of mania or psychosis, or history of mania or psychosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Eligibility Evaluation

Participants are evaluated for eligibility and randomized to active or sham arm

1 week

Treatment

Participants receive either active or sham tDCS treatment for Major Depressive Disorder

10 weeks

Video interviews and self-reports

Open-label Extension (optional)

Participants may opt into continuation of active tDCS treatment

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The REACH-tDCS study tests the safety and effectiveness of Sooma tDCS, a brain stimulation device used at home to treat depression. It's compared against a sham (placebo) version in a randomized, blinded setup over 10 weeks plus an optional continuation.

How Is the Trial Designed?

Group I: Active treatment Experimental Treatment 1 Intervention

Group II: Sham treatment Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Sooma Medical Inc

Lead Sponsor

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 As the primary outcome, depressive symptoms showed significant improvement when measured using the Hamilton Depression Rating Scale: active 9.41 ± 6.25 point ...

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. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11464394/

Efficacy and Safety of Transcranial Direct Current ... The tDCS was effective as an antisuicide treatment for acute bipolar depression patients with suicidal ideation, with minimal side effects reported.

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. 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)].