Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study
Medical University of South Carolina
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.
Description
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 i…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ages 18-70. * Current MDD diagnosis (MINI v7). * Baseline PHQ-9 \> 9. * Capacity to consent * Fluent English. Exclusion Criteria: * Bipolar or psychotic disorder * Primary anxiety disorders without concomitant major depression as defined above * Current significant suicidal ideation or behaviors require a higher level of care. * Use of neuromodulation therapies (e.g., ECT, TMS, VNS) within the past 6 months. * History of seizures, implanted cranial/ cardiac metal, or neurosurgery. * Use of medications that significantly reduce seizure threshold * Frequent/severe HA * P…
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.
Location
- MUSC Brain Stimulation LabCharleston, South Carolina