Developing an EEG Probe for Studying Effects of Non-invasive Cortical and Spinal Cord Electrical Stimulation on Cognitive Control in Post Stroke Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- EEG oscillations
研究概览
简要总结
This study aims to investigate effects of transcranial current stimulation (tES) and transcutaneous direct current stimulation (tsDCS) associated changes on fronto-parietal EEG and cognitive performance in patients with post stroke depression (PSD)
详细描述
The investigators will perform a double blind, randomized, sham controlled, crossover study design to assess effects of tES, tsDCS and sham stimulation on the performance during a cognitive control task. The working Hypothesis is tsDCS and/or tES will enhance frontal theta oscillations as recorded on EEGs and improve task performance compared to sham stimulation.
Results from this project can potentially lead to the development of a new research tool for assessing neuromodulation strategies to treat mental disorders and their comorbidities. It will also uncover the neural correlates of cognitive deficits in PSD and provide feasible biomarkers associated with treatment response in support of a larger clinical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will include both male and female of age over 18 years and a BMI of 18-35 Kg/mts2 who have experienced stroke.
- •Moderately depressed, MADRS:18-28, PHQ9: 10-20 and/or experiencing cognitive impairments after stroke
排除标准
- •Current or lifetime bipolar disorder or schizophrenia diagnosis;
- •current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed);
- •significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year:
- •current chronic severe pain conditions;
- •current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month);
- •skin lesions on electrode placement region;
- •implanted electrical medical devices;
- •suspected IQ<80, and 10) any other clinically relevant reason as judged by the clinician.
结局指标
主要结局
EEG oscillations
时间窗: change from baseline
Theta (4-8 Hz) oscillations in the mid frontal EEG
次要结局
- Behavior(during procedure)
研究者
Ishita Basu
Associate Professor
University of Cincinnati