Estimating the Sensitivity of a Mobile Neuro-cognitive Platform ("BrainE") to Detect Neural Plasticity and Cognitive Enhancements Following Theta-burst Stimulation to Superior Frontal/dACC TMS Stimulation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Post vs. Pre Change in Mid-frontal Theta Oscillations for iTBS vs. cTBS Stimulation
研究概览
简要总结
This is a study to determine whether particular forms of brain-stimulation, applied to superior frontal cortex/preSMA can affect cognition and associated frontal theta oscillations. To perform this study, the investigators first measure brain activity and cognitive performance using "BrainE", a cognitive task platform that assesses cognition on sustained attention, response inhibition, working memory, interference processing and emotion processing assessments. Next, the investigators apply brain-stimulation over a mid-frontal region associated with these tasks (mid-line frontal activity overlying superior frontal cortex/pre-SMA area). Finally, human subjects perform the "BrainE" task assessments again immediately after the brain-stimulation. The investigators compare the effects of brain stimulation on average frontal activity evoked across the cognitive tasks, and on the cognitive performance averaged across tasks. The investigators primarily compare the effects of two types of brain-stimulation against each other: intermittent Theta-Burst Stimulation (a protocol designed to excite brain activity) and continuous Theta-Burst-Stimulation (a stimulation protocol designed to inhibit brain activity).
详细描述
- Brain/Behavior Recordings: to measure brain activity as described above, the investigators first ask subjects to engage in a cognitive assessment set while measuring EEG activity. For this study, the assessment set consists of the following tasks: (1) sustained attention; (2) response inhibition; (2) visuo-spatial working-memory; (3) Flanker interference processing, and (4) emotional interference processing. This battery takes about 30 minutes to complete. 24 channel EEG recordings are performed simultaneous to the cognitive tasks. Subjects perform the "BrainE" cognitive assessment, then receive brain-stimulation, and will then immediately be tested on the BrainE assessment again.
- Brain-Stimulation: Each subject will be asked to come in twice for this study, separated by 1 week. On week one they will receive one stimulation protocol, and on the subsequent week they will receive the other (order determined randomly for each subject). The intermittent Theta-Burst-Stimulation protocol (iTBS) consists of a similar burst pattern (3 stimulation pulses 20ms apart; each burst applied every 200ms). However, after 10 bursts (2 seconds of stimulation) there is a pause for 8 seconds. 200 bursts are still applied, however due to the inter-burst intervals, this paradigm takes 200 seconds. The continuous Theta-Burst-Stimulation protocol (cTBS) consists of a burst of three stimulation pulses, applied 20ms apart; with each burst occurring every 200ms. Thus, every second participants receive 5 bursts. This continues for 40 seconds, such that participants in total receive 200 bursts or 600 pulses.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigators will assess for each subject whether they have any guess, a priori, as to hypothesized effects of the iTBS vs. cTBS protocols (improve, impair or no change on cognition). Participant/care provider will know which stimulation is being applied (iTBS, cTBS based on labels A & B), but will not know the hypothesized effects of these two protocols. iTBS and cTBS protocols will be masked as "treatment A" and "treatment B", prior to handing the data over to PI/outcomes assessor. Analyses will thus be performed to assess whether treatment "A" or treatment "B" has an effect on cognition; and whether there are differences between these treatment protocols.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adequate decisional capacity to make a choice about participating in this research study.
排除标准
- •No major active neurologic/psychiatric disease
- •No contraindications for rTMS
- •No behavioral/medical factors that increase risk of seizure
结局指标
主要结局
Post vs. Pre Change in Mid-frontal Theta Oscillations for iTBS vs. cTBS Stimulation
时间窗: (Post-Pre) iTBS and (Post-Pre) cTBS signals were measured one week apart.
Change in superior frontal stimulus-evoked theta oscillations were measure on a set of cognitive tasks, specifically selective attention, response inhibition, working memory, interference processing and emotion processing tasks. The evoked EEG response (mid-frontal theta FCz as a source for superior frontal theta) was averaged across all cognitive tasks to yield a global cognitive task-averaged signal that was measured immediately before (Pre) and immediately after (Post) iTBS, and similarly immediately before (Pre) and immediately after (Post) cTBS.
次要结局
- Post vs. Pre Change in Cognitive Performance((Post-Pre) iTBS and (Post-Pre) cTBS cognitive performance levels were measured one week apart.)
研究者
Jyoti Mishra
Asst Professor IR
University of California, San Diego