MUSC Brain Stimulation Lab
Charleston, South Carolina, 29407, United States
Location status: Recruiting
Location contact
Clayton Olash, MD
CONTACT
Elisabeth Collins, BS
CONTACT
NCT Number: NCT07226011
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29407, United States
Location status: Recruiting
Clayton Olash, MD
CONTACT
Elisabeth Collins, BS
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 7 days
Defined as events requiring hospitalization or emergency care during the stimulation period.
Time frame: Completion of all planned stimulation sessions without dropout due to adverse effects.
Up to 5 days
Time frame: Daily during treatment (Days 1-5)
Average Likert-scale ratings of discomfort, headache, or skin irritation.
Time frame: Baseline to Day 5
Self-reported depression severity using a validated scale.
Time frame: Baseline to Day 5
Subjective cognitive performance measured via standardized instrument.
Time frame: Baseline to Day 5
Self-reported mindfulness using a validated scale.
Time frame: Baseline to 4 weeks post-treatment
Longitudinal assessment of symptom durability.
Time frame: Within 30 days of MRI scan
Retrospective modeling of intracerebral current flow using structural MRI.
Medical University of South Carolina
Other
Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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