Accelerated High-Dose tDCS for Depression

NCT07226011 | Recruiting DMC FDA Device

• 2 other identifiers: Pro00146983R25DA020537
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depression; Major Depression Disorders

Keywords

Depression; Nervous System; tDCS; Interventional; Brain Stimulation; Transcranial Direct Stimulation

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (5)

• Change in Depression Severity Score From Baseline to Post-Treatment

  Baseline to Day 5

• Change in Cognitive Function Score From Baseline to Post-Treatment

  Baseline to Day 5

• Change in Mindfulness Score From Baseline to Post-Treatment

  Baseline to Day 5

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

  Baseline to 4 weeks post-treatment

• Electric Field Intensity in Target Brain Regions Based on MRI Modeling

  Within 30 days of MRI scan

Study Arms (1)

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.

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

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.

Experimental: High-Dose tDCS Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-70.
• Current MDD diagnosis (MINI v7).
• Baseline PHQ-9 \> 9.
• Capacity to consent
• Fluent English.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

MUSC Brain Stimulation Lab

Charleston, South Carolina, 29407, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Neurologic Manifestations

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Clayton Olash, MD

  Medical University of South Carolina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished University Professor of Psychiatry, Radiology and Neuroscience

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 10, 2025
• Study Start: December 15, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)