Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Cognitive Post-acute Sequelae of COVID-19 (PASC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in EEG P300 event-related potential
研究概览
简要总结
The main goal of this study is to improve dysexecutive symptoms (e.g., sustained attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19 (PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive method that uses low intensity electric currents delivered to the brain through stimulation electrodes on the scalp.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent
- •A diagnosis of PASC as indicated by past COVID-19 infection, and persistent symptoms, including 'brain fog', confusion, short-term memory deficits, trouble concentrating, delirium, difficulties in multitasking.
排除标准
- •History of epilepsy
- •Metallic implants in the head and neck,
- •Brain stimulators
- •Pacemakers
- •Pregnancy
- •Active substance dependence (except for tobacco)
- •Premorbid major neurological illness
- •Severe mental illness (e.g., bipolar disorder, schizophrenia)
- •Attention Deficit Hyperactivity Disorder
研究组 & 干预措施
Sham tDCS
This group will receive daily sham stimulation to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
干预措施: Sham tDCS (Device)
Active tDCS
This group will receive daily active stimulation (2 mA) to the left dorsolateral prefrontal cortex for 4 weeks through a home-based tDCS device in remotely-supervised 30-min sessions.
干预措施: Active tDCS (Device)
结局指标
主要结局
Change in EEG P300 event-related potential
时间窗: 8 weeks
EEG P300 amplitudes time-locked to the incongruent trials of the Eriksen Flanker Task will be assessed at four time points before, during, and after the 4-week intervention.
Change in inhibitory control
时间窗: 8 weeks
Performance during the incongruent trials of the Eriksen Flanker Task will be assessed at four time points before, during, and after the 4-week intervention.
Change in processing speed
时间窗: 8 weeks
Reaction time during the incongruent trials of the Eriksen Flanker Task will be assessed at four time points before, during, and after the 4-week intervention.
次要结局
未报告次要终点
研究者
Hamdi Eryilmaz, PhD
Assistant Professor
Massachusetts General Hospital