RecruitingNot ApplicableNCT07226011

Accelerated High-Dose tDCS for Depression

Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study


Sponsor

Medical University of South Carolina

Enrollment

20 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

In this study, investigators are testing whether a higher dose of a non-invasive brain stimulation technique, called transcranial direct current stimulation (tDCS), can be safely used in people with depression. Participants will come to the Brain Stimulation Lab and receive mild electrical stimulation through electrodes placed on their scalp. The study begins with a safety run-in, where the first few participants will receive stimulation at gradually increasing levels (2, 4, and 6 milliamps) while being closely monitored. If no serious side effects are found, later participants will receive repeated 6 milliamp sessions for 5 days total. Investigators will check skin comfort, mood, and overall tolerability after each session.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an accelerated, high-dose version of transcranial direct current stimulation (tDCS) — a non-invasive brain stimulation technique that uses mild electrical currents — as a treatment for depression. The goal is to see if this approach can quickly improve depressive symptoms. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with major depressive disorder (MDD) - Your depression symptoms are at a moderate-to-severe level (PHQ-9 score above 9) - You speak English fluently **You may NOT be eligible if...** - You have bipolar disorder or a psychotic condition - You have serious suicidal thoughts or behaviors requiring immediate intensive care - You have used brain stimulation therapies (like ECT or TMS) in the past 6 months - You have a history of seizures, metal implants in your head or chest, or brain surgery - You are pregnant - You have a moderate-to-severe substance use disorder - You have skin conditions or wounds on the scalp where electrodes would be placed 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)

Participants receive transcranial direct current stimulation (tDCS) using a high-dose (6 mA) protocol delivered twice daily for five consecutive weekdays (10 sessions total). The first three participants complete a Day 1 in-lab dose-escalation (2 mA → 4 mA → 6 mA) with a Day 2 skin integrity check before continuing at 6 mA. All sessions last 20 minutes and are followed by adverse-event monitoring.


Locations(1)

MUSC Brain Stimulation Lab

Charleston, South Carolina, United States

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NCT07226011


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