Accelerated High-Dose tDCS for Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18-70.
Current MDD diagnosis (MINI v7).
Baseline PHQ-9 > 9.
Capacity to consent
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Transcranial Direct Current Stimulation (tDCS)
DeviceParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Experimental: High-Dose tDCS InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Device-Related Serious Adverse Events
Defined as events requiring hospitalization or emergency care during the stimulation period.
Time frame
Up to 7 days2
Number of Participants Completing All Scheduled Sessions Without Discontinuation
Up to 5 days
Time frame
Completion of all planned stimulation sessions without dropout due to adverse effects.3
Mean Score on Adverse Event Questionnaire
Average Likert-scale ratings of discomfort, headache, or skin irritation.
Time frame
Daily during treatment (Days 1-5)Secondary outcomes
1
Change in Depression Severity Score From Baseline to Post-Treatment
Self-reported depression severity using a validated scale.
Time frame
Baseline to Day 52
Change in Cognitive Function Score From Baseline to Post-Treatment
Subjective cognitive performance measured via standardized instrument.
Time frame
Baseline to Day 53
Change in Mindfulness Score From Baseline to Post-Treatment
Self-reported mindfulness using a validated scale.
Time frame
Baseline to Day 54
Change in Depression Severity Score From Baseline to 4-Week Follow-Up
Longitudinal assessment of symptom durability.
Time frame
Baseline to 4 weeks post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov