What side effects are associated with this type of intervention?

Common treatments for Major Depressive Disorder (MDD) similar to Transcranial Direct Current Stimulation (tDCS) include repetitive Transcranial Magnetic Stimulation (rTMS) and Electroconvulsive Therapy (ECT). Side effects of tDCS are generally mild and may include skin irritation at the electrode site, headache, and dizziness. rTMS can cause scalp discomfort, headache, and, in rare cases, seizures. ECT is associated with more significant side effects such as memory loss, confusion, and physical side effects related to anesthesia. These treatments are generally considered when patients do not respond to conventional pharmacotherapy or psychotherapy.

What prior FDA approvals exist?

The FDA has approved several neuromodulation treatments for Major Depressive Disorder (MDD), including Electroconvulsive Therapy (ECT) and repetitive Transcranial Magnetic Stimulation (rTMS). ECT has been a long-standing treatment for severe depression, while rTMS, which uses magnetic fields to stimulate nerve cells in the brain, was approved in 2008 for patients who have not responded to antidepressant medications. Although tDCS, which modulates neuronal activity by applying a low electrical current to the brain, shows promise in clinical trials, it has not yet received FDA approval for the treatment of MDD.

What other types of research exist?

Promising novel alternatives to tDCS for Major Depressive Disorder include: 1) Repetitive Transcranial Magnetic Stimulation (rTMS), which has shown efficacy in treatment-resistant depression and can be used for maintenance therapy. 2) Deep Brain Stimulation (DBS), which is investigational but has shown promising results in preliminary trials for treatment-refractory depression. 3) Vagus Nerve Stimulation (VNS), which has demonstrated long-term benefits in treatment-resistant depression. 4) Electroconvulsive Therapy (ECT), which remains a highly effective option, particularly for severe cases, despite its side-effect profile.

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tDCS for Major Depressive Disorder (NESBID Trial)

N/A

Waitlist Available

Led By Serdar M Dursun, MD, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Currently suffering from an MDE with a score on the Montgomery-Åsberg Depression Rating Scale (MADRS) greater than 34 (signifying severe depression)

Have ultra treatment resistant MDD (defined as failure to remit despite adequate trials with five antidepressants, or failure to remit with ECT, or failure to remit with ketamine)

Must not have

Have an electronic implant, cardiac dysrhythmia, seizure disorder, neurological disorder, or neurosurgical history, as the safety of electrical stimulation with tDCS cannot be assured given these comorbidities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion

Summary

This trial tests tDCS, a non-invasive brain stimulation technique, on patients with severe depression who haven't responded to multiple treatments. The goal is to see if tDCS can help improve their mood by using a small electrical current to stimulate specific brain areas. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has been investigated for its potential to treat depression, especially in patients who do not respond well to medication.

Who is the study for?

This trial is for adults with severe depression who haven't improved after trying at least five different antidepressants, ECT, or ketamine. It's not suitable for pregnant women, those using certain herbal compounds or NMDA-modulating agents, people with psychosis or specific personality disorders, and individuals with electronic implants or certain neurological conditions.

What is being tested?

The NESBID trial tests if brain stimulation (transcranial direct current stimulation) helps people with ultra treatment-resistant major depressive disorder. Participants will get either real or sham stimulation over several weeks to see if it improves their depression symptoms compared to usual treatments.

What are the potential side effects?

Possible side effects of transcranial direct current stimulation may include discomfort at the electrode sites on the head, itching, tingling sensations during the procedure, headache afterwards, fatigue and in rare cases mood changes.

Eligibility Criteria

Inclusion Criteria

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

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I am currently experiencing severe depression.

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My depression hasn't improved after trying five different antidepressants, ECT, or ketamine.

Exclusion Criteria

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

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I do not have a pacemaker, irregular heartbeats, seizures, brain disorders, or brain surgery history.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 2 weeks, after 4 weeks, after 6 weeks/trial completion, and 1 month after trial completion for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary study objectives

Exploratory language analysis

FIBSER

Lexical decision making task

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active transcranial direct current stimulationExperimental Treatment1 Intervention

Active transcranial direct current stimulation (tDCS), delivered at 2 mA and for 30 minutes, on sequential weekdays, for a total of 30 sessions. Participants will continue to receive their usual pharmacotherapy and psychotherapy.

Group II: Sham transcranial direct current stimulationPlacebo Group1 Intervention

Sham transcranial direct current stimulation (tDCS), which will ramp up to 2 mA over 17 s, and then ramp down to and remain at 0.3 mA for the remainder of the 30 minute session. The short period of active stimulation is included to stimulate the somatic sensations of active therapy. The trickle current at 0.3 mA is necessary to measure electrode contact and prevent investigators from deducing that the device is no longer active. Participants will receive the sham therapy on sequential weekdays for a total of 30 sessions. Participants will continue to receive their usual pharmacotherapy and psychotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial direct current stimulation

2012

Completed Phase 3

~650

0 / 3Eligibility 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

The most common treatments for Major Depressive Disorder (MDD) include pharmacotherapy, psychotherapy, and neuromodulation techniques such as Transcranial Direct Current Stimulation (tDCS). tDCS modulates neuronal activity by applying a low electrical current to specific areas of the brain, such as the dorsolateral prefrontal cortex, which is often underactive in depression. This modulation can enhance neuroplasticity and improve mood regulation. Other neuromodulation techniques like repetitive Transcranial Magnetic Stimulation (rTMS) and Electroconvulsive Therapy (ECT) also aim to alter brain activity patterns to alleviate depressive symptoms. These treatments are crucial for MDD patients, especially those with treatment-resistant depression, as they offer alternative options when traditional therapies fail.