Accelerated High-Dose tDCS for Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Direct Current Stimulation (tDCS).
- Who it may be relevant to
- Registry conditions: Major Depression, Major Depression Disorders. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study
Overview
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.
Detailed 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 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.
Interventions
- 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.
Primary outcome measures
- Number of Participants With Device-Related Serious Adverse Events [Time frame: Up to 7 days]
- Number of Participants Completing All Scheduled Sessions Without Discontinuation [Time frame: Completion of all planned stimulation sessions without dropout due to adverse effects.]
- Mean Score on Adverse Event Questionnaire [Time frame: Daily during treatment (Days 1-5)]
Secondary outcome measures (5)
- Change in Depression Severity Score From Baseline to Post-Treatment [Time frame: Baseline to Day 5]
- Change in Cognitive Function Score From Baseline to Post-Treatment [Time frame: Baseline to Day 5]
- Change in Mindfulness Score From Baseline to Post-Treatment [Time frame: Baseline to Day 5]
- Change in Depression Severity Score From Baseline to 4-Week Follow-Up [Time frame: Baseline to 4 weeks post-treatment]
- Electric Field Intensity in Target Brain Regions Based on MRI Modeling [Time frame: Within 30 days of MRI scan]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- MUSC Brain Stimulation Lab — Charleston
Identifiers
NCT: NCT07226011 · Pro00146983 · R25DA020537