Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07226011

Accelerated High-Dose tDCS for Depression

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants With Device-Related Serious Adverse Events

    Time frame: Up to 7 days

    Defined as events requiring hospitalization or emergency care during the stimulation period.

  2. Number of Participants Completing All Scheduled Sessions Without Discontinuation

    Time frame: Completion of all planned stimulation sessions without dropout due to adverse effects.

    Up to 5 days

  3. Mean Score on Adverse Event Questionnaire

    Time frame: Daily during treatment (Days 1-5)

    Average Likert-scale ratings of discomfort, headache, or skin irritation.

Secondary outcomes

  1. Change in Depression Severity Score From Baseline to Post-Treatment

    Time frame: Baseline to Day 5

    Self-reported depression severity using a validated scale.

  2. Change in Cognitive Function Score From Baseline to Post-Treatment

    Time frame: Baseline to Day 5

    Subjective cognitive performance measured via standardized instrument.

  3. Change in Mindfulness Score From Baseline to Post-Treatment

    Time frame: Baseline to Day 5

    Self-reported mindfulness using a validated scale.

  4. Change in Depression Severity Score From Baseline to 4-Week Follow-Up

    Time frame: Baseline to 4 weeks post-treatment

    Longitudinal assessment of symptom durability.

  5. Electric Field Intensity in Target Brain Regions Based on MRI Modeling

    Time frame: Within 30 days of MRI scan

    Retrospective modeling of intracerebral current flow using structural MRI.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2025
Registry last updated
Jul 13, 2026

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.

Published trials that share one or more normalized conditions with this study.