Accelerated High-Dose tDCS for Depression

NCT ID: NCT07226011

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-03-31

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.

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.

Conditions

Major Depression; Major Depression Disorders

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: High-Dose tDCS Intervention

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.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Current or past diagnosis of treatment-resistant depression, defined as failure of ≥2 adequate antidepressant trials at any point.
• If on an antidepressant:

• Must be on a stable dose for ≥4 months prior to enrollment.
• No medication changes (dose or agent) during the study period.
• 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.
• Diagnosis of personality disorder
• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clayton Olash, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R25DA020537

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00146983

Identifier Type: -

Identifier Source: org_study_id