Accelerated High-Dose tDCS for Depression: An Open-Label Outpatient Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Number of Participants With Device-Related Serious Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current MDD diagnosis (MINI v7).
- •Baseline PHQ-9 >
- •Capacity to consent
- •Fluent English.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
Number of Participants With Device-Related Serious Adverse Events
时间窗: 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
时间窗: Completion of all planned stimulation sessions without dropout due to adverse effects.
Up to 5 days
Mean Score on Adverse Event Questionnaire
时间窗: Daily during treatment (Days 1-5)
Average Likert-scale ratings of discomfort, headache, or skin irritation.
次要结局
- Change in Depression Severity Score From Baseline to Post-Treatment(Baseline to Day 5)
- Change in Cognitive Function Score From Baseline to Post-Treatment(Baseline to Day 5)
- Change in Mindfulness Score From Baseline to Post-Treatment(Baseline to Day 5)
- Change in Depression Severity Score From Baseline to 4-Week Follow-Up(Baseline to 4 weeks post-treatment)
- Electric Field Intensity in Target Brain Regions Based on MRI Modeling(Within 30 days of MRI scan)
研究者
Mark George
Distinguished University Professor of Psychiatry, Radiology and Neuroscience
Medical University of South Carolina