Accelerated high-dose transcranial direct current stimulation for depression
Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study
NA · Medical University of South Carolina · NCT07226011
This trial will try higher-dose tDCS to see if it is safe and tolerable for adults with major depression.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT07226011 on ClinicalTrials.gov |
What this trial studies
This interventional protocol uses a safety run-in to escalate transcranial direct current stimulation (tDCS) dose in adults with major depressive disorder. The first participants receive gradually increasing currents (2, 4, then 6 mA) under close monitoring, and if no serious adverse effects are observed later participants receive repeated 6 mA sessions over five days. Investigators will check skin integrity, headache, mood ratings, and overall tolerability after each session to document safety and feasibility. The trial is conducted at the MUSC Brain Stimulation Lab in Charleston, South Carolina and enrolls adults aged 18–70 with current MDD and PHQ-9 > 9.
Who should consider this trial
Good fit: Adults aged 18–70 with current major depressive disorder (PHQ-9 > 9), capacity to consent, fluent English, and without excluded medical or psychiatric conditions are ideal candidates.
Not a fit: People with bipolar or psychotic disorders, recent neuromodulation, seizure history, implanted cranial or cardiac metal, active moderate-severe substance use disorder, or skin problems at electrode sites are unlikely to receive benefit or will be excluded.
Why it matters
Potential benefit: If successful, this could enable stronger, faster-acting noninvasive brain stimulation options for patients who do not fully respond to current depression treatments.
How similar studies have performed: Prior tDCS trials using lower currents (≤2 mA) have shown modest clinical effects and good tolerability, but delivering 6 mA is novel with limited prior human safety data.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Charleston, South Carolina
- MUSC Brain Stimulation Lab — Charleston, South Carolina, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depression, Major Depression Disorders, Depression, Nervous System, tDCS, Interventional, Brain Stimulation, Transcranial Direct Stimulation