Actively Recruiting
Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study
Led by Medical University of South Carolina · Updated on 2026-05-12
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a higher dose of transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, in adults with major depressive disorder (MDD). This study aims to determine if delivering 6 milliamps (mA) of electrical stimulation is safe and feasible, as previous studies mostly used lower currents (up to 2 mA). This pilot study addresses the need to find better treatment options for depression, which often does not respond well to current therapies. Participants will receive high-dose tDCS treatment consisting of twice-daily 20-minute sessions at 6 mA for five consecutive weekdays, totaling 10 sessions. The first three participants will undergo a safety run-in with gradually increasing doses on the first day (2 mA to 4 mA to 6 mA) and a skin check on the second day before continuing the full 6 mA sessions. Electrical stimulation is applied via electrodes on the scalp, and the study is conducted openly without a placebo group. During the study, participants will have baseline, post-treatment, and 4-week follow-up assessments to measure depressive symptoms, cognitive function, and tolerability. Researchers will monitor skin condition, mood changes, and any adverse effects daily during treatment. The main outcomes include the number of serious device-related side effects, completion rates of all sessions, and scores from an adverse event questionnaire. The study will last from initial treatment through a month after finishing the sessions to observe lasting effects and safety.
CONDITIONS
Brief Title
Accelerated High-Dose tDCS for Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 70 years
- Current diagnosis of major depressive disorder confirmed by MINI v7
- Baseline PHQ-9 score greater than 9
- Ability to provide informed consent
- Fluent in English
You will not qualify if you...
- Diagnosis of bipolar or psychotic disorder
- Primary anxiety disorders without major depression
- Current significant suicidal thoughts or behaviors requiring higher care
- Use of neuromodulation therapies (ECT, TMS, VNS) in past 6 months
- History of seizures, implanted cranial or cardiac metal, or neurosurgery
- Use of medications that significantly lower seizure threshold
- Frequent or severe headaches
- Personal history of head trauma, concussion, or traumatic brain injury
- Unable to complete consent process due to catatonia or other reasons
- Current moderate to severe alcohol or substance use disorder
- Skin conditions under electrode sites like eczema, severe rashes, blisters, open wounds, burns, cuts, or irritation
- Pregnancy (urine test required for women of childbearing potential)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days
The first three participants complete an in-lab dose-escalation with 2 mA, 4 mA, and 6 mA sessions on Day 1, followed by a skin integrity check on Day 2 before continuing high-dose treatment.
2 visits (in-person)
Duration - 5 days
Participants receive high-dose transcranial direct current stimulation (tDCS) at 6 mA twice daily for five consecutive weekdays, with each session lasting 20 minutes and followed by adverse-event monitoring.
10 visits (in-person, twice daily sessions)
Duration - 4 weeks post-treatment
Participants complete post-intervention assessments immediately after treatment and a follow-up assessment 4 weeks later to monitor depressive symptoms, cognition, and tolerability.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
MUSC Brain Stimulation Lab
Charleston, South Carolina, United States, 29407
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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