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.
Major depressive disorder (MDD) remains one of the leading causes of disability worldwide, with many patients experiencing inadequate response to currently available treatments. Transcranial direct current stimulation (tDCS) has shown promise as a non-invasive, well-tolerated neuromodulation technique for depression, but nearly all prior studies have used lower current intensities (≤2 mA). Preliminary modeling and experimental work suggest that higher current dosing may be necessary to achieve sufficient engagement of cortical targets and produce stronger clinical effects. The present study is designed to address this gap by systematically evaluating the safety, tolerability, and feasibility of high-dose tDCS delivered at 6 mA in adults with MDD. Establishing safety at this higher intensity is a critical step before pursuing larger efficacy trials. By carefully monitoring adverse events and skin integrity during an initial run-in phase, this study provides an evidence base for whether 6 mA tDCS can be safely implemented in a clinical population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
MUSC Brain Stimulation Lab
Charleston, South Carolina, United States
Number of Participants With Device-Related Serious Adverse Events
Defined as events requiring hospitalization or emergency care during the stimulation period.
Time frame: Up to 7 days
Number of Participants Completing All Scheduled Sessions Without Discontinuation
Up to 5 days
Time frame: Completion of all planned stimulation sessions without dropout due to adverse effects.
Mean Score on Adverse Event Questionnaire
Average Likert-scale ratings of discomfort, headache, or skin irritation.
Time frame: Daily during treatment (Days 1-5)
Change in Depression Severity Score From Baseline to Post-Treatment
Self-reported depression severity using a validated scale.
Time frame: Baseline to Day 5
Change in Cognitive Function Score From Baseline to Post-Treatment
Subjective cognitive performance measured via standardized instrument.
Time frame: Baseline to Day 5
Change in Mindfulness Score From Baseline to Post-Treatment
Self-reported mindfulness using a validated scale.
Time frame: Baseline to Day 5
Change in Depression Severity Score From Baseline to 4-Week Follow-Up
Longitudinal assessment of symptom durability.
Time frame: Baseline to 4 weeks post-treatment
Electric Field Intensity in Target Brain Regions Based on MRI Modeling
Retrospective modeling of intracerebral current flow using structural MRI.
Time frame: Within 30 days of MRI scan
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