35 Participants NeededMy employer runs this trial

tDCS for Depression

SP
GP
Overseen ByGiuseppina Pilloni
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether transcranial direct current stimulation (tDCS), a type of brain stimulation, can help individuals with moderate depression by improving their sleep patterns at home. The goal is to determine if better sleep through tDCS correlates with reduced depression symptoms. Suitable participants have moderate depression, are on stable doses of antidepressants, and have access to a quiet space for home treatment. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for enhancing mental health and sleep.

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

If you are taking antidepressant medication, you can continue as long as the dose has been stable for at least 30 days before the trial. However, you cannot use any prescription or over-the-counter sleep medications during the study.

What prior data suggests that this device is safe for treating depression?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people with moderate depression. Several studies found tDCS to be as safe as a sham (fake) treatment, meaning it did not cause more side effects than a placebo. Most reported side effects were mild and temporary, such as skin irritation or headache.

Additionally, home-based tDCS treatments proved safe and well-received by patients. When used for depression, tDCS has been linked to positive results and few side effects. One study indicated that even higher doses of tDCS did not increase side effects, suggesting it is well-tolerated.

Overall, existing evidence reassures people considering this treatment that tDCS is a safe option with few serious risks.12345

Why are researchers excited about this trial?

Most treatments for depression involve medication or psychotherapy, but transcranial direct current stimulation (tDCS) offers a unique alternative. tDCS uses a mild electrical current to stimulate specific areas of the brain, specifically the dorsolateral prefrontal cortex, which is associated with mood regulation. This non-invasive method is particularly exciting because it can be done at home, offers potential benefits without the side effects often associated with medication, and could provide quicker relief. Researchers are thrilled about tDCS because it represents a promising shift towards more accessible and patient-friendly options for managing depression.

What evidence suggests that tDCS is effective for depression?

Research has shown that transcranial direct current stimulation (tDCS) can help reduce symptoms of depression. One study found that tDCS led to small but noticeable improvements in depression. Another study suggested that using tDCS at home, along with regular treatments, might also help with both depression and anxiety. In this trial, participants will complete a 20-session course of home-based tDCS. It's important to understand that while tDCS looks promising, it doesn't work for everyone. Overall, tDCS is considered a safe and potentially useful option for treating depression.46789

Who Is on the Research Team?

GP

Giuseppina Pilloni

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with moderate major depression who can read English, have a confirmed diagnosis of depression, stable antidepressant medication (if any), access to local care or resources, and a quiet space at home for sessions. They must be able to give consent and follow study instructions.

Inclusion Criteria

My antidepressant dose has not changed in the last 30 days.
5. Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms OR confirmed acknowledgement and identification of local resources.
6. Able to provide informed consent and comply with study procedures.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-administer tDCS for 20 sessions at home to evaluate effects on sleep and depressive symptoms

5 weeks
20 sessions (home-based)

Follow-up

Participants are monitored for changes in depressive symptoms and sleep efficiency

4 weeks
Final Follow-Up Study Visit (Month 2)

What Are the Treatments Tested in This Trial?

Interventions

  • tDCS

Trial Overview

The study tests whether using transcranial direct current stimulation (tDCS) at home helps improve sleep patterns and mood in people with moderate depression. Participants will use tDCS devices during the trial while their symptoms are monitored.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Active transcranial direct current stimulation (tDCS)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Zabara Foundation

Collaborator

Citations

1.

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 ...

Efficacy and safety of home-based transcranial direct ...

Case series suggest that home-based tDCS, when combined with standard therapies, may improve both depressive and anxiety symptoms. Additionally, ...

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 ...

Transcranial Electrical Stimulation in Treatment of ...

Transcranial direct current stimulation and transcranial alternating current stimulation was associated with positive outcomes among patients with MDD and DPC ...

Efficacy of transcranial direct current stimulation for ...

The results showed that active tDCS was associated with statistically significant, though small, improvements in depressive symptoms and ...

Efficacy and safety of home-based transcranial direct current ...

Case series suggest that home-based tDCS, when combined with standard therapies, may improve both depressive and anxiety symptoms. Additionally, ...

Efficacy and Safety of Transcranial Direct Current Stimulation ...

This randomized clinical trial evaluates the efficacy and safety of transcranial direct current stimulation as add-on therapy in patients with bipolar ...

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.

Home-based transcranial direct current stimulation ...

A 10-week home-based tDCS treatment with remote supervision in MDD showed high efficacy, acceptability and safety.