What side effects are associated with this type of intervention?

Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation technique used to treat various psychiatric conditions, including suicidal thoughts. Common side effects of tDCS include mild skin irritation or redness at the electrode sites, tingling sensations, and headaches. Other neuromodulation treatments, such as Transcranial Magnetic Stimulation (TMS), may cause scalp discomfort, mild headaches, and, rarely, seizures. Electroconvulsive Therapy (ECT), another treatment for severe depression and suicidal thoughts, can lead to short-term memory loss, confusion, and muscle aches. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for suicidal thoughts, particularly focusing on neuromodulation techniques. Electroconvulsive therapy (ECT) is one such FDA-approved treatment that has been used for severe depression and suicidal ideation. While tDCS (Transcranial Direct Current Stimulation) is being studied for its feasibility and effectiveness in preventing suicidal ideation, it has not yet received FDA approval specifically for this indication. Other neuromodulation techniques, such as repetitive transcranial magnetic stimulation (rTMS), have also been explored for their potential benefits in treating depression and associated suicidal thoughts, though their primary FDA approvals are for major depressive disorder rather than specifically for suicidal ideation.

What other types of research exist?

Promising novel alternatives to tDCS for treating suicidal thoughts include Electroconvulsive Therapy (ECT) and Vagus Nerve Stimulation (VNS). ECT has shown efficacy in treatment-resistant depression, which can include suicidal ideation, with rapid symptom improvement. VNS has also demonstrated positive outcomes in long-term studies for treatment-resistant depression, potentially reducing suicidal thoughts.

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Behavioural Intervention

Home-Based Brain Stimulation for Suicidal Thoughts

N/A

Waitlist Available

Led By Alexandre Paim Diaz, MD, PhD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

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

Must have

Age between 18 and 65 years

Diagnosis of mood or bipolar disorder registered in the electronic hospital medical record

Must not have

Unstable medical condition with reduction of functional capacity

History of epilepsy or seizures in the last year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the level of side effects will be assessed at the end of each rs-tdcs session and at days 14 [+ 7 days], 30 [+ 7 days], and 60 [+ 10 days] from the first rs-tdcs session

Summary

This trial aims to test if tDCS, a method that uses small electrical currents to stimulate the brain, can be safely used at home for adults with major affective disorders who are at high risk for suicide after leaving the hospital. The study will involve 20 participants and will assess their progress over a period of time. The goal is to see if this treatment can help reduce suicidal thoughts during this critical period. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has shown promise in treating depression and other psychiatric disorders.

Who is the study for?

Adults aged 18-65 with mood or bipolar disorders, living in Monroe County with internet access and a private space for treatment. They must have had suicidal thoughts at admission but not at enrollment, and be able to use the tDCS device after training. Excluded are those with unstable health, skin conditions near stimulation sites, neurodegenerative diseases, recent seizures or substance abuse issues.

What is being tested?

The study tests if home-based tDCS can prevent suicidal thoughts post-hospital discharge. It's a double-blind trial where half of the participants will receive real tDCS and half sham (fake) treatment over two weeks, followed by assessments on day 14, 30 and 60.

What are the potential side effects?

tDCS is generally well-tolerated but may cause mild side effects like itching or tingling at the electrode site during application; headache; fatigue; nausea; or insomnia.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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My medical records show a diagnosis of mood or bipolar disorder.

Exclusion Criteria

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

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My health condition limits my daily activities.

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I have had epilepsy or seizures in the past year.

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I have had a head injury or brain surgery in the past.

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I am currently undergoing electroconvulsive therapy or transcranial magnetic stimulation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this information will be collected after the final rs-tdcs session (that is, the tenth rs-tdcs session)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this information will be collected after the final rs-tdcs session (that is, the tenth rs-tdcs session)

This trial's timeline: 3 weeks for screening, Varies for treatment, and this information will be collected after the final rs-tdcs session (that is, the tenth rs-tdcs session) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility of the intervention

Secondary study objectives

Acceptability of the intervention

Depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

Intensity of rumination as assessed by the Ruminative Responses Scale (RRS)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

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

The active home-based tDCS delivers a constant current intensity of 2mA on the subject's scalp, with electrodes positioned bilaterally (anodal-left and cathodal-right), on the dorsolateral prefrontal cortex (DLPFC), for 30 minutes.

Group II: Sham home-based transcranial direct current stimulation (tDCS)Placebo Group1 Intervention

The sham home-based tDCS looks identical to a typical active home-based tDCS cap but delivers a 30-second ramp-up (0-2 mA) stimulation followed by a 30-second ramp-down (2-0 mA) at the beginning and end of the application.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Home-based transcranial direct current stimulation (tDCS)

2023

N/A

~10

0 / 6Eligibility 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

Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation technique that modulates neuronal activity by delivering a low electrical current to specific brain regions. This current can either increase or decrease neuronal excitability, depending on the polarity of the electrodes used. For patients with suicidal thoughts, tDCS can help by altering the activity in brain areas associated with mood regulation and cognitive control, potentially reducing the intensity and frequency of suicidal ideation. This matters because it offers a targeted approach to modulate brain function without the systemic side effects associated with pharmacological treatments, providing a promising alternative or adjunctive therapy for individuals at high risk of suicide.