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临床试验/NCT00029939
NCT00029939已完成不适用

Real-Time Analysis of Scalp Electroencephalography and Magnetoencephalography During Production of Human Voluntary Movement

National Institute of Neurological Disorders and Stroke (NINDS)1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2002年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1

研究概览

简要总结

This study will use electroencephalography (EEG) to examine how the brain prepares for movement. It will look at 1) what changes occur in a person's brain just before voluntary movement, 2) when the changes occur, 3) how consistent the changes are, and 4) how the changes vary from person to person. The information from this study will be applied to other studies, such as exploring how brain changes that signal movement can be used to control prostheses in patients with spinal cord injuries or stroke.

Healthy normal volunteers 18 years of age and older may be eligible for this study. People with neurologic or psychiatric disorders and people taking medicines that may affect brain signals (e.g., Valium) may not participate.

Participants will come to the NIH Clinical Center on two separate days for testing sessions of 2 to 3 hours each. At each session, an EEG cap will be placed on the head to record brain signals, and electrodes will be placed on the arms to record movement. Subjects will perform simple movements during the EEG recording, such as flexing their arm of clenching their fist. Researchers will use the first recording to determine the pattern of how the brain prepares for movement. During the second recording, they will try to predict the subjects' movements, based on the patterns discerned in the first recording.

详细描述

Human voluntary movement is associated with at least two distinct types of scalp electroencephalographic (EEG) changes. Event-related potentials are slow, with DC signals developing in the bifrontal region as early as 1.5 seconds prior to movement. They are detected by averaging multiple events in the time domain and generally require at least 40-50 events to allow detection of the signal within the noise. Frequency changes however, are more robust and may be seen reliably on individual traces. The frequency changes occur in the alpha (8-13 Hz) range as well as beta (13-30 Hz) and may occur up to 2 seconds before movement. This leads to the notion that real-time analysis of the EEG may allow one to predict individual movement. If this could be done reliably, it may provide further insight about how the brain prepares for movement, as well as potential therapeutic options such as control of cortically based prosthetic device.

Our initial study, henceforth Phase 1, is an exploratory study using real-time EEG to identify the factors that allow one to reliably predict normal human voluntary movement. Subjects will be normal volunteers, studied in the EEG lab in the Human Motor Control Section. Subjects will be asked to perform a simple motor task involving a sequence of finger movements while undergoing a routine EEG recording with surface electromyography. The EEG will then be processed using standard techniques to identify the location and time course of EEG signals in response to movement. Once this has occurred, subjects will return for a real-time study that will use their individually identified factors to predict their movement. The effects of training on the accuracy of prediction will also be explored by scheduling multiple real-time prediction sessions per subject over the course of several weeks. The rate of successful movement prediction will be the primary outcome measure.

After we are able to accurately predict movement intention with healthy volunteers, i.e., the false positive rate is under 20% with the false negative rate under 50%, we will study whether we can achieve the same prediction accuracy with stroke patients and patients with primary lateral sclerosis (PLS) or amyotrophic lateral sclerosis (ALS). The stroke patients and ALS/PLS patients will perform the same procedure as the subjects in the Phase 1 part of the trial.

Phase 2 of the investigation will extend to a different type of movement, reaching, and to an additional parameter, the spatial field of the intended target of the movement. In addition, Phase 2 will also include magnetoencephalography (MEG) as well as EEG methods to classify the spatiotemporal features of these movement parameters. Successful prediction of the intended goals of reaches to either ipsilateral or contralateral fields, prior to the onset of movement will be the main outcome measure of phase 2 of the study.

In Phase 3 of the investigation, healthy volunteers will perform a simple finger movement task which will be analyzed with special attention given to the timing of the intention to move and to how the intention affects the EEG signal. In order to assess whether spontaneous movements without prior instruction are associated with different physiological markers from typical self-paced paradigms, a recording session will be performed after the EEG cap is placed without instructing the subject.

研究设计

研究类型
Observational

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

  • 未提供

排除标准

  • 未提供

研究者

研究点 (1)

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