What side effects are associated with this type of intervention?

Transcranial Direct Current Stimulation (tDCS) is generally well-tolerated, with common side effects including mild skin irritation or tingling at the electrode sites, headache, and dizziness. In comparison, Electroconvulsive Therapy (ECT) can cause more significant side effects such as short-term memory loss, confusion, and physical side effects related to anesthesia. Repetitive Transcranial Magnetic Stimulation (rTMS) may lead to headaches, scalp discomfort, and, rarely, seizures. Overall, tDCS tends to have fewer and less severe side effects compared to ECT and rTMS.

What prior FDA approvals exist?

Transcranial Direct Current Stimulation (tDCS) is a neuromodulation technique involving a mild, constant electrical current passed between scalp electrodes. While tDCS itself is still under investigation, other neuromodulation treatments for depression have received FDA approval. These include Electroconvulsive Therapy (ECT), which uses electrical currents to induce seizures for therapeutic effect, and Repetitive Transcranial Magnetic Stimulation (rTMS), which uses magnetic fields to stimulate specific brain regions. Both ECT and rTMS are established treatments for major depressive disorder, particularly in cases resistant to pharmacotherapy.

What other types of research exist?

Promising, novel alternatives to tDCS for depression patients include: 1) Electroconvulsive Therapy (ECT), which has robust evidence supporting its efficacy, especially in treatment-resistant cases. 2) Vagus Nerve Stimulation (VNS), which has shown positive outcomes in long-term studies for treatment-resistant depression. 3) Deep Brain Stimulation (DBS), particularly targeting the subcallosal cingulate, which has demonstrated clinical improvements in treatment-resistant depression. 4) Repetitive Transcranial Magnetic Stimulation (rTMS), which has been effective in reducing depressive symptoms and functional disability.

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Transcranial Electrical Stimulation

Transcranial Direct Current Stimulation for Depression

N/A

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently experiencing symptoms of depression (Patient Health Questionnaire 9, PHQ9 >4 at screening; Hamilton Depression Rating Scale 17-item, HDRS-17, score >8 at Visit 1)

Capacity to provide informed consent

Must not have

Ages below 18 (neurobiology is quite different in children vs. adults)

tES contraindications: skin conditions or injuries on the scalp hair extensions, wigs, braids, etc. that cannot be removed prior to the study, metal implants or pacemakers (also contraindicated for MRI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week, 2 weeks, 1 month

Summary

This trial studies how tDCS, a technique using mild electrical currents, affects brain function and depressive symptoms in adults with major depression. The goal is to see if this method can improve brain activity and reduce depression after a short period of treatment. Transcranial direct current stimulation (tDCS) has been investigated for the treatment of depression since 2006.

Who is the study for?

Adults aged 18-65 with a confirmed diagnosis of Major Depressive Disorder for at least one year, currently experiencing symptoms of depression, and under a stable antidepressant regimen can participate. They must be able to consent and not have any MRI contraindications like metal implants or claustrophobia.

What is being tested?

The trial is testing the effects of transcranial direct current stimulation (tDCS), which involves passing mild electrical currents through the scalp, on brain function in depressed adults using fMRI imaging. Some participants will receive sham treatment as a comparison.

What are the potential side effects?

Potential side effects may include discomfort at the electrode sites on the scalp, itching or tingling during stimulation, fatigue, headache, nausea or insomnia post-treatment. Serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently experiencing symptoms of depression.

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I understand and can agree to the study's procedures and risks.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am 18 years old or older.

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I don't have scalp conditions, hair extensions I can't remove, or metal implants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week, 2 weeks, 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week, 2 weeks, 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 2 weeks, 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in brain functional connectivity

Secondary study objectives

Changes in depressive symptoms (Beck)

Changes in depressive symptoms (Hamilton)

Side effects data

From 2021 Phase 2 & 3 trial • 160 Patients • NCT02483468

skin irritation

Car accident

100%

80%

60%

40%

20%

Study treatment Arm

tDCS (Active)

tDCS (Sham)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

Group II: ShamPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Direct Current Stimulation

2014

Completed Phase 3

~1100

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression include pharmacotherapy, electroconvulsive therapy (ECT), and neuromodulation techniques such as Transcranial Direct Current Stimulation (tDCS). Pharmacotherapy typically involves antidepressants that modulate neurotransmitter levels, such as serotonin and norepinephrine, to improve mood and cognitive function. ECT induces controlled seizures to alter brain chemistry and connectivity, providing rapid symptom relief. tDCS uses a mild, constant electrical current passed between scalp electrodes to modulate neuronal activity and connectivity in targeted brain regions. Understanding these mechanisms is crucial for patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects.