Quantifying tACS-driven Improvement of Working Memory in Depression
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 主要终点
- Resting state EEG
研究概览
简要总结
TACS is an emergent method of non-invasive neuromodulation which can engage frequency-specific brain oscillations. It is increasingly recognized that neural oscillations play a system-organizing role in the brain. Evidence suggests that disorganized neural oscillations may also influence functionality of cognitive processes such as working memory. Thus, as TACS can affect neural oscillatory activity in the human brain in a non-invasive manner, it has promise to transform mental health care. The premise of this proposed work is that tACS concurrent with multi-session working memory (WM) focused skills will facilitate durable working memory and stabilized neural oscillations. Depression offers an excellent model to study the effects of tACS. The study seeka to administer 2mA of tACS using theta oscillations to improve working memory concerns associated with depression. The purpose of this study is to investigate the electrophysiological and behavioral effects of transcranial alternating current stimulation (tACS) in humans and to explore specific improvements in working memory and depressive symptoms. This study is placebo-controlled study. Participants will undergo pre- and post-assessments and either theta or sham tACS for 5 days. During each session, the volunteer will perform cognitive tasks while receiving tACS. Assessment sessions will include cognitive tasks, questionnaires, a clinical interview, and EEG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years old.
- •Stated willingness to participate and comply with all study procedures.
- •Stated availability for the duration of the study.
- •Meet criteria for Major Depressive Disorder.
- •Agreement to adhere to lifestyle considerations throughout study duration.
- •No conflict of interest with the Department of Biomedical Engineering at the University of Minnesota.
- •Confident level of English language.
排除标准
- •History or evidence of chronic neurological disorder (e.g., history of seizures, epilepsy, unexplained episodes of loss of consciousness, serious brain injury, severe or frequent headaches)
- •Metal or electric implant in the head, neck or chest area.
- •Implanted pacemakers or other electrically, magnetically, ir mechanically activated implant
- •Vascular clips or other electrically sensitive support systems in the brain
- •Serious health conditions (e.g., congestive heart failure pulmonary obstructive chronic disease, active neoplasia)
- •History of head injuries.
- •Pregnancy or breast-feeding.
- •Significant damage of skin at sites of stimulation or other skin concerns, such as dermatitis, psoriasis, or eczema
- •Alcohol or drug addiction.
- •Any legal reason why the candidate cannot participate.
- •Concurrent enrollment in another scientific or clinical study.
- •Estimated IQ is below 70, defined by the WTAR.
- •Active suicidality or other non-controlled neuropsychiatric illness. Active suicidality will be excluded based on a C-SSRS score of 3 or above in the last 6 months. Severe depression is defined as a PHQ-9 score above 20, which will also be excluded.
- •A lifetime suicide attempt.
研究组 & 干预措施
control group
participants with depressive disorder
干预措施: sham tACS stimulation (Other)
Active group
participants with depressive disorder
干预措施: theta tACS stimulation (Other)
结局指标
主要结局
Resting state EEG
时间窗: Day 35
examine theta power and connectivity with the EEG recordings
working memory skills
时间窗: Day 5
Using a cognitive task that will consist of test responses (correct / incorrect) and reaction time (in ms). The task will include looking at faces expressing different emotions and matching them with previous images.
task-based EEG
时间窗: Day 35
examine theta power and connectivity with the EEG recordings
Resting state EEG
时间窗: Day 6
examine theta power and connectivity with the EEG recordings
task-based EEG
时间窗: Day 6
examine theta power and connectivity with the EEG recordings
次要结局
未报告次要终点