RecruitingNot ApplicableNCT07042217

Transcranial Direct Current Stimulation for Depression

A Randomized, Double-blind, Parallel-arm, Sham-controlled Trial of ElectraRx Mindfulness Transcranial Direct Current Treatment System (Elect-MDS) for Adults With Major Depressive Disorder


Sponsor

Soterix Medical

Enrollment

25 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) — which sends a very mild electrical current through the scalp to stimulate specific brain areas — can help reduce symptoms of major depression when added to existing antidepressant medication. **You may be eligible if...** - You have been clinically diagnosed with major depressive disorder (MDD) according to standard psychiatric criteria - You are currently going through a depressive episode that has lasted at least 4 weeks - You score above a certain threshold on standard depression rating scales - You have been on the same antidepressant medication for at least 30 days **You may NOT be eligible if...** - You have a history of bipolar disorder or other types of mood conditions - You have a metal implant in your head or a medical device that could be affected by the stimulation - Your depression has a different primary diagnosis driving it - Your medication has changed recently (within 30 days) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEtranscranial direct current stimulation (tDCS) and mindfulness instruction

tDCS together with audio providing mindfulness instruction and music

DEVICESham tDCS and Mindfulness

Placebo electrical sitmulation and audio-guided mindfulness instruction


Locations(1)

Soterix Medical, Inc.

Woodbridge, New Jersey, United States

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NCT07042217


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