Major DepressionNCT07226011
Accelerated High-Dose tDCS for Depression
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Major Depression and Major Depression Disorders, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depression, Major Depression Disorders
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-70.
- Current MDD diagnosis (MINI v7).
- Baseline PHQ-9 > 9.
- Capacity to consent
- Fluent English.
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
MUSC Brain Stimulation Lab
Charleston, South Carolina, 29407
About this study
Official title: Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study
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.
Read the 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
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- Depression, Nervous System, tDCS, Interventional, Brain Stimulation, Transcranial Direct Stimulation
- Medical subject headings
- Depressive Disorder, Major, Depression, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Device-Related Serious Adverse Events
Defined as events requiring hospitalization or emergency care during the stimulation period.
Measured: Up to 7 days
Number of Participants Completing All Scheduled Sessions Without Discontinuation
Up to 5 days
Measured: 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.
Measured: Daily during treatment (Days 1-5)
Secondary outcomes (5)
Change in Depression Severity Score From Baseline to Post-Treatment
Self-reported depression severity using a validated scale.
Measured: Baseline to Day 5
Change in Cognitive Function Score From Baseline to Post-Treatment
Subjective cognitive performance measured via standardized instrument.
Measured: Baseline to Day 5
Change in Mindfulness Score From Baseline to Post-Treatment
Self-reported mindfulness using a validated scale.
Measured: Baseline to Day 5
Change in Depression Severity Score From Baseline to 4-Week Follow-Up
Longitudinal assessment of symptom durability.
Measured: Baseline to 4 weeks post-treatment
Electric Field Intensity in Target Brain Regions Based on MRI Modeling
Retrospective modeling of intracerebral current flow using structural MRI.
Measured: Within 30 days of MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start15 Dec 2025
- Primary completion28 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mark George, Medical University of South Carolina
- Investigators
- Clayton Olash, MD, Study director, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226011
- Sponsor's protocol ID
- Pro00146983
- Other IDs
- R25DA020537
- Status last verified
- Aug 2026
- First submitted
- 4 Nov 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study
- ClinicalTrials.gov ID
- NCT07226011
- Acronym / sponsor ID
- Pro00146983
- Conditions
- Major Depression, Major Depression Disorders
- Keywords
- Depression, Nervous System, tDCS, Interventional, Brain Stimulation, Transcranial Direct Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: High-Dose tDCS Intervention | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18-70.
- Current MDD diagnosis (MINI v7).
- Baseline PHQ-9 > 9.
- Capacity to consent
- Fluent English.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental: High-Dose tDCS Intervention |
Primary outcome
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.
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
Mean Score on Adverse Event Questionnaire
Time frame: Daily during treatment (Days 1-5)
Average Likert-scale ratings of discomfort, headache, or skin irritation.
5 secondary outcomes
Change in Depression Severity Score From Baseline to Post-Treatment
Time frame: Baseline to Day 5
Change in Cognitive Function Score From Baseline to Post-Treatment
Time frame: Baseline to Day 5
Change in Mindfulness Score From Baseline to Post-Treatment
Time frame: Baseline to Day 5
Change in Depression Severity Score From Baseline to 4-Week Follow-Up
Time frame: Baseline to 4 weeks post-treatment
Electric Field Intensity in Target Brain Regions Based on MRI Modeling
Time frame: Within 30 days of MRI scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clayton Olash, MD study director
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Major Depression and Major Depression Disorders, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Device-Related Serious Adverse Events (time frame: Up to 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.