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| ID | Type | Description | Link |
|---|---|---|---|
| R25DA020537 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: High-Dose tDCS Intervention | Experimental | Participants in this single-arm, open-label pilot study will receive high-dose transcranial direct current stimulation (tDCS) for major depressive disorder. Each participant undergoes twice-daily 20-minute sessions at 6 mA for five consecutive weekdays (total of 10 sessions). The first three participants complete an in-lab dose-escalation safety run-in (2 mA → 4 mA → 6 mA on Day 1) with a Day 2 skin integrity check before continuing at 6 mA twice daily for the remaining days. All participants complete baseline, post-intervention, and 4-week follow-up assessments of depressive symptoms, cognition, and tolerability. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Device-Related Serious Adverse Events | Defined as events requiring hospitalization or emergency care during the stimulation period. | Up to 7 days |
| Number of Participants Completing All Scheduled Sessions Without Discontinuation | Up to 5 days | 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. | Daily during treatment (Days 1-5) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression Severity Score From Baseline to Post-Treatment | Self-reported depression severity using a validated scale. | Baseline to Day 5 |
| Change in Cognitive Function Score From Baseline to Post-Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clayton Olash, MD | Medical University of South Carolina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUSC Brain Stimulation Lab | Recruiting | Charleston | South Carolina | 29407 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 4, 2025 | Nov 4, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 4, 2025 | Nov 4, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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The model will include a safety run-in with the first 3 patients, to ensure there are no serious side effects to the dose escalation from 2 mA to 6 mA before enrolling the remaining participants.
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Subjective cognitive performance measured via standardized instrument.
| Baseline to Day 5 |
| Change in Mindfulness Score From Baseline to Post-Treatment | Self-reported mindfulness using a validated scale. | Baseline to Day 5 |
| Change in Depression Severity Score From Baseline to 4-Week Follow-Up | Longitudinal assessment of symptom durability. | 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. | Within 30 days of MRI scan |
| D001519 |
| Behavior |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |