tDCS for Treatment-Resistant Depression

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Psychotropics

Disqualifiers: Substance use, Schizophrenia, Autism, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 20

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcranial direct current stimulation (tDCS) can aid individuals with major depressive disorder who haven't found relief with other treatments. tDCS is a gentle, noninvasive procedure that delivers small electrical currents to the brain. The study will test whether higher doses of this treatment more effectively improve depression symptoms. Individuals who have tried at least three depression medications without success and are currently experiencing depression might be suitable candidates for this trial.

As an unphased trial, this study offers a unique opportunity to explore a novel treatment approach for those seeking new options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that there be no changes in psychotropic medication within 30 days before starting the treatment. This suggests you should maintain your current medication regimen without changes before and during the trial.

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

Previous studies have shown that tDCS is safe and well-tolerated. Research indicates no major differences in drop-out rates or side effects between those receiving real tDCS and those undergoing sham treatment. Even at higher doses, the safety profile remains consistent. This makes tDCS a promising noninvasive option for people with treatment-resistant depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for treatment-resistant depression because it offers a non-invasive alternative to typical medications and therapies. Unlike standard treatments like antidepressants or electroconvulsive therapy, tDCS uses mild electrical currents to stimulate specific brain areas, potentially enhancing mood with fewer side effects. This method allows for an adjustable dosage, ranging from 0 to 4 mA, providing a personalized approach to therapy. Moreover, with its quicker administration time of just 20 minutes per session across a few weeks, tDCS may offer more immediate relief compared to traditional options.

What evidence suggests that tDCS is effective for treatment-resistant depression?

Studies have shown mixed results for using transcranial direct current stimulation (tDCS) to treat depression. Some research suggests that tDCS can significantly reduce symptoms, especially in moderate cases. For example, one study found that a 10-week course of tDCS led to noticeable mood improvements. However, other studies indicate that tDCS may not work as well for people whose depression hasn't improved with other treatments. While some patients do feel better, the evidence isn't strong enough to fully recommend tDCS for treatment-resistant depression. Overall, tDCS shows promise, but its effectiveness for difficult-to-treat cases remains uncertain. Participants in this trial will receive tDCS using an adaptive protocol to further evaluate its potential benefits for treatment-resistant depression. ^{1 3 4 6 7}

Who Is on the Research Team?

Charles Conway, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with treatment-resistant major depressive disorder, as indicated by a failure of at least three antidepressant trials and a Hamilton Depression Rating Scale score of 17 or higher. Participants must speak English well but cannot join if they have certain mental health conditions, recent medication changes, neurological disorders, skin issues where electrodes are placed, metal implants in the head, severe head injuries, chronic headaches or seizures.

Inclusion Criteria

I have been diagnosed with major depressive disorder and currently have symptoms.

Baseline score of Hamilton Depression Rating Scale 17-item (HDRS-17) score of 17 or higher

Good command of the English language

Exclusion Criteria

I have a history of chronic headaches or migraines.

Current pregnancy or lactation

I am currently experiencing symptoms of psychosis.

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 using an adaptive protocol with doses of 0 to 4 mA, with twenty 20-minute sessions over 4 to 6 weeks

4-6 weeks

20 visits (in-person)

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 study tests whether higher doses of transcranial direct current stimulation (tDCS), up to 4 milliamps over sessions lasting 20 minutes each for 4-6 weeks can improve symptoms in patients with treatment-resistant depression. It's an open-label study meaning everyone knows what treatment is being given.

How Is the Trial Designed?

Group I: tDCS Experimental Treatment 1 Intervention

Patients will receive transcranial direct current stimulation using an adaptive protocol allowing for doses of 0 to 4 mA during the course of the treatment, with twenty 20-minute sessions over the course of 4 to 6 weeks. Treatments will take place daily, 5 days per week.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Transcranial direct current stimulation (tDCS) is shown to be as safe and acceptable as sham treatment in patients with major depressive disorder (MDD), with dropout rates of 8.8% for active tDCS and 12% for sham, indicating no significant difference.

The study analyzed data from 6 randomized clinical trials, revealing that while adverse event rates were slightly higher in the active tDCS group (73.5%) compared to sham (68.3%), the difference was not statistically significant, suggesting that tDCS is well-tolerated in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data. Moffa, AH., Brunoni, AR., Fregni, F., et al.[2019]

In a study involving 22 patients with treatment-resistant major depression, anodal transcranial direct current stimulation (tDCS) did not show a significant improvement in depression scores compared to placebo after 2 weeks of treatment.

Despite the lack of overall efficacy in reducing depression scores, tDCS was associated with increased positive emotions, suggesting potential benefits that warrant further investigation with improved protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in treatment resistant depression: a randomized double-blind, placebo-controlled study. Palm, U., Schiller, C., Fintescu, Z., et al.[2022]

Transcranial direct current stimulation (tDCS) is generally considered a safe treatment for major depressive disorder, with very low side effects reported, making it a viable option for patients.

While meta-analyses indicate some efficacy of tDCS for acute depression with a moderate effect size, its effectiveness is reduced in treatment-resistant cases, suggesting that more research is needed to establish its overall therapeutic value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tDCS for the treatment of depression: a comprehensive review. Palm, U., Hasan, A., Strube, W., et al.[2018]

A systematic review of 158 studies involving 4130 participants found that repeated sessions of transcranial direct current stimulation (tDCS) do not significantly increase the risk of adverse events compared to sham treatments.

The study indicated that adverse event rates were consistent across different diagnostic groups, suggesting that tDCS is generally safe for various populations, although the potential for rare adverse events cannot be completely excluded.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of repeated sessions of transcranial direct current stimulation: A systematic review. Nikolin, S., Huggins, C., Martin, D., et al.[2019]

Transcranial direct current stimulation (tDCS) showed significant antidepressant effects in a study of 64 participants with depression, with improved mood after active treatment compared to sham treatment.

While tDCS was generally safe, there was a cautionary note regarding mood switching in individuals with bipolar disorder, as one participant experienced hypomania after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for depression: 3-week, randomised, sham-controlled trial. Loo, CK., Alonzo, A., Martin, D., et al.[2022]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838763

Personalized High-Definition Transcranial Direct Current ... Overall, our findings demonstrate the clinical potential of personalized HD-tDCS as a safe and fast-acting antidepressant therapy for moderate ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2324242625000129

Comparison of the efficacy of high-definition transcranial ... All groups demonstrated significant improvement in depressive symptoms and cognitive function. The rTMS group exhibited a significantly greater decrease in ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26232699/

Transcranial direct current stimulation (tDCS) in the ... Conclusions: tDCS may be efficacious for treatment of MDE. The data do not support the use of tDCS in treatment-resistant depression, or as an add-on ...

4. 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11293779/

Effectiveness and tolerability of adjunctive transcranial ... Results: There was a significant reduction in outcome assessment after tDCS intervention as compared to baseline, with more than 50% of the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00667680

Transcranial Direct Current Stimulation (tDCS) in ... This study will investigate the possible antidepressant effects of tDCS in patients with therapy resistant major depressive episodes.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032717304937

Safety and acceptability of transcranial direct current ... Active tDCS is as acceptable and safe as sham in randomized clinical trials of MDD. · Higher tDCS doses did not affect the overall acceptability.