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临床试验/NCT04239274
NCT04239274撤回不适用

Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury: A Study of the Effect of Transcranial Electrical Stimulation of the Ventrolateral Prefrontal Cortex on Response Inhibition

Medical University of South Carolina0 个研究点开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Average Reaction Time During Stop Signal Task

研究概览

简要总结

Transcranial electrical stimulation (tES) is a non-invasive form of brain stimulation that has previously been to shown to have therapeutic potential in traumatic brain injury (TBI) patients. In this study, the study team will use a brain activity monitor (electroencephalogram, EEG) and a computer-based task to observe the effects of different forms of tES, like transcranial direct current stimulation (tDCS) and transcranial pulsed current stimulation (tPCS), on impulse control and sustained attention in people with TBI. Additionally, the study team will measure how much tDCS and tPCS affect the brain activity of a specific area of the brain associated with impulse control and attention. Problems with response inhibition have been shown to make rehabilitation more difficult for people with TBI. It also reduces social functioning and can also negatively affect job performance, which ultimately lead to a decreased quality of life. A better understanding of the effects of tES in TBI patients could be informative in finding out what its therapeutic potential is for this population.

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
Single (Participant)

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects referred to the PI for management of TBI
  • Subject is at least 3 months post-injury at the time of consent
  • Ages 25-70

排除标准

  • Subjects with the inability to consent for themselves
  • Subjects with body habitus that does not allow the EEG cap to be properly placed
  • Presence of scalp injury or disease
  • Allergic reaction to topical lidocaine jelly
  • Prior intracranial surgery or skull-fracture over VLPFC
  • Presence of hemorrhage on intracranial imaging
  • Prior brain radiotherapy
  • Prior history of intracranial tumor, intracranial infection, or cerebrovascular malformation
  • Subjects with the inability to see and read from a computer screen
  • History of any form of seizures prior to TBI or within 6 months of study participation
  • Pregnancy

结局指标

主要结局

Average Reaction Time During Stop Signal Task

时间窗: Throughout study (1 hour)

The Stop Signal Task (SST) is an assessment which requires participants to respond to various stimuli with a specific action and to not respond when a "stop" stimulus is presented.

EEG power in all frequency bands

时间窗: Baseline and immediately post Stimulation

They will be fitted with a standard EEG cap consisting of 32 EEG electrodes placed in the 10/20 international system format, a standardized system for EEG electrode placement. Frequency bands will be measured.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nathan Rowland

Assistant Professor

Medical University of South Carolina

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