RECRUITINGINTERVENTIONAL

Accelerated High-Dose tDCS for Depression

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Ages 18-70. - Current MDD diagnosis (MINI v7). - Baseline PHQ-9 \> 9. - Capacity to consent - Fluent English. Who Should NOT Join This Trial: - 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 - Personal history of head trauma, concussion, or TBI - Catatonic or otherwise unable to perform the consent process - Current alcohol or substance-use disorder (moderate-severe). - Any non-uniformities in the skin under the electrode site, including eczema, severe rashes, hyperhidrosis, communicable skin disorders, sensitive skin (ex. eczema, severe rashes), blisters, open wounds, burns including sunburns, cuts or irritation (e.g. due to shaving), or other skin defects or lesions, as determined by clinical personnel - Pregnancy (urine test required for women of childbearing potential). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 * Personal history of head trauma, concussion, or TBI * Catatonic or otherwise unable to perform the consent process * Current alcohol or substance-use disorder (moderate-severe). * Any non-uniformities in the skin under the electrode site, including eczema, severe rashes, hyperhidrosis, communicable skin disorders, sensitive skin (ex. eczema, severe rashes), blisters, open wounds, burns including sunburns, cuts or irritation (e.g. due to shaving), or other skin defects or lesions, as determined by clinical personnel * Pregnancy (urine test required for women of childbearing potential).

Treatments Being Tested

DEVICE

Transcranial 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