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临床试验/NCT06920992
NCT06920992已完成不适用

Network Mechanisms of Cognitive Control

Kai Hwang1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2020年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
184
试验地点
1
主要终点
Cognitive flexibility performance as measured by accuracy, in the unit of percent of accurate responses.

研究概览

简要总结

The goal of this research project is to investigate how brain lesions affect our ability to generate goal-directed behaviors - a cognitive function commonly referred to as cognitive control. To support goal-directed behaviors, the human brain must adaptively direct thoughts and actions depending on the current goals and contexts. Our principal hypothesis is that this cognitive capacity depends on a brain network architecture that can flexibly transmit, select, and inhibit information along neural pathways. Therefore, lesions and damages to critical brain network components will negatively affect behavior. To faithfully assess the structure and function of human brain networks and its disruption from brain lesions, investigators will recruit healthy adult human subjects and patients with brain lesions to participate in a multi-session study that includes cognitive behavioral tests, structural magnetic resonance imaging (MRI) using a 3 Tesla (3T) scanner, and electroencephalography (EEG) studies. During all testing sessions, subjects will perform cognitive tasks that assess their ability to select, maintain, and inhibit sensory information and generate motor responses. Their eye movements may be passively recorded during testings. 3T MRI allows for fast and high-resolution imaging of brain structures, enabling us to identify lesion loci. Investigators will use EEG to measure the electrophysiology of brain activities. All behavioral, EEG, and MRI data collected will be sent to the National Institute of Mental Health Data Archive (NDA) at the National Institute of Mental Health (NIMH).

详细描述

There are 3 types of testing procedures, (cognitive behavioral testing, EEG, and MRI,) that investigators will describe in detail below. The types of procedures involved vary from participant to participant, depending on what kind of data investigators need and which procedure subjects agree to participate. The subject may participate in all testing procedures, (MRI, EEG, and behavioral,) two or three. The subject is also free to decline any of the testing procedures, equivalent to not participating in the research study. For each procedure, the testing time will never exceed 3 hours, so the maximum time commitment for the subject will be 9 hrs. For each subject, no more than two testing procedures will occur within 24 hours. When two testing procedures occur within the same 24-hour period, the time between the two testing procedures will be whatever is most convenient for the subject. The time between testing procedures that do not occur within the same 24-hour period will be whatever is most convenient for the subject, (this could mean weeks or months depending on the subject.) The specific procedure(s) the subject agrees to participate in will be checked on the consent form. The order which a subject will participate in these three types of procedures will also vary from subject to subject, which depends on the subject's schedule and the availability of the research facilities.

COGNITIVE BEHAVIORAL PROCEDURES: The type of cognitive task that will be administered aimed at measuring subject's ability to monitor internal goals and intentions, maintain and manipulate information in working memory, select task-relevant information, inhibit distractions, and organize action plans to accomplish these goals. These tasks involve the presentation of visual or auditory stimuli through a computer system, and the subjects must pay attention to the presented stimuli and make button press responses. Their eye movements may be monitored by a non-invasive eye-tracking device placed 1 to 2 feet in front of the participants. The eye-tracking device passively records the subject's eye gaze direction and no part of the device will be touching the subject, therefore, there will be no negative impact on the subject's comfort. The testing time for this procedure will be 1 to 3hrs.

EEG PROCEDURES: In this procedure, subjects will have EEG recorded while concurrently monitoring behavior. Subjects are asked to sit in a testing room and have conventional EEG electrodes placed on their scalp with conducting paste. The experiments involve the presentation of images on a computer monitor, sounds through speakers or headphones. The tasks may be changed flexibly as required by our behavioral testing of the tasks (i.e., is this task too easy for subjects? Too hard? These are questions investigators can only answer once investigators begin piloting the task behaviorally), however the task will always be asking subjects to manipulate the simple or complex stimuli in mind and respond to the participants in a brief period of time. The task will get at our questions about cognitive control by engaging brain regions involved in memorizing stimuli, attending to stimuli, ignoring stimuli, and preparing responses. These are components of cognitive control that are of interest for this project. The subject is asked to respond to certain stimuli by pressing a button. All stimuli are presented at a comfortable level. Similar to the cognitive behavioral procedure, a non-invasive eye tracking device may record subject's eye movements during EEG recording. This eye-tracking device is non-invasive and no parts of the device will cause any discomfort or interfere with the EEG recording. An EEG recording session typically takes 1 to 3hrs. The subject is given breaks every 5- 10 minutes, but may request a break or stop the experiment at any time. After the testing, investigators will remove the electrodes, and provide shampoo and towels for subjects to wash off the EEG conducting paste. Investigators will provide a hairdryer.

MRI (3T) PROCEDURES: Before participants enter the magnet room, participants will be screened for contradictions (i.e., metal implant). If the subject also wears glasses that contain metal to correct their visual acuity to 20/40 or better, investigators will have the subject use plastic, MR-compatible glasses provided by the MRI center. If the subject knows their prescription it will expedite the process of finding lenses suitable for the participants. If not, a few minutes will be allocated to trying on the best fitting pair to approximate the vision required to view the screen within the MRI, which is positioned close to subjects' face. Brain anatomical MRI scans are collected. Brain anatomical MRI scans are collected to determine the location of brain structures. In MRI studies, subjects who have history of brain MRIs will be acclimated to the MRI environment in a mock scanner. This is performed at a dedicated setup at MRRF in PBDB. For comfort, foam pads are placed around the subject's head to limit head movement during the scan. A MRI scanning session takes about 40 - 60 minutes and the subject is given breaks every 5-10 minutes. The subject may request a break or stop the experiment at any time.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Healthy adults age 18-35 without neurological or psychological disorders. No metal implants. No Claustrophobia.
  • Patients with focal lesions within the thalamus. Age 18 or older. No diagnosis of psychiatric disorders. No metal implants. No Claustrophobia.
  • Patients with focal lesions that spare the frontal and parietal cortices. Age 18 or older. No diagnosis of psychiatric disorders.
  • No metal implants. No Claustrophobia.

排除标准

  • claustrophobic Psychiatric conditions such as depression and ADHD. Implanted device such as cardia pacemakers and autodefbrillaotors, aneurysm, cochlear implants.
  • Not fluent in English.

研究组 & 干预措施

Determine how the thalamus contributes to cognitive control

Experimental

We conducted cognitive behavioral testing on cognitive flexibility using EEG, fMRI and behavioral experiments. The intervention for all three methods (EEG, fMRI, behavioral) were the same, subjects performed a cognitive flexibility task with three conditions: extradimensional shift, intradimensional shift, and no switching condition. With all three experiments we can measure the behavioral accuracy. With fMRI we can measure evoked fMRI response amplitude in the thalamus, with EEG we can measure scalp voltage signal in patients.

干预措施: measuring cognitive flexibility including working memory and set-switching (Behavioral)

结局指标

主要结局

Cognitive flexibility performance as measured by accuracy, in the unit of percent of accurate responses.

时间窗: 2 weeks

Accuracy measure of the behavioral task will determine whether the hypothesized cognitive function of cognitive flexibility is impaired. Impairment will lead to below chance response.

Cognitive flexibility function as measured by reaction time to cognitive switching manipulation, un the unit of seconds.

时间窗: 2 weeks

The speed of cognitive switching can be measured by the reaction time to stimulus, in seconds.

Cognitive Flexibility Performance as Measured by Accuracy, in the Unit of Percentage of Correct Responses

时间窗: 2 weeks

The accuracy measure of the behavioral task will determine whether the hypothesized cognitive function of cognitive flexibility is implemented by a hierarchical cognitive control model instantiated in the human thalamus. A lower accuracy scale for the extradimensional shift condition (EDS) relative to other conditions would suggest increased difficulty in engaging in cognitive flexibility. The scale is from 0 to 100.

Measure of Thalamus Response to Cognitive Flexibility, in the Unit of fMRI BOLD Signal Increase Relative to no Stimulus Presentation.

时间窗: 2 hours

When subjects perform the cognitive flexibility task, we can then measure how strongly the medial thalamus responds to different task conditions. The signal scale will be in beta coefficients measured by fMRI BOLD response. This is a measurement of relative signal increase in response to the presented task. A higher beta value for the thalamus for the extradimensional shift condition would indicate thalamus involvement in cognitive flexibility. The scale is from -100 to 100

次要结局

  • EEG Oscillations in the Theta Frequency Band, in the Unit of Signal Increase Relative to Recordings From no Stimulus Presentation.(2hrs)

研究者

发起方
Kai Hwang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kai Hwang

Associate Professor

University of Iowa

研究点 (1)

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