Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029939
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2002-01-26
Brief Title:
Brain Activity During Production of Movement
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Real-Time Analysis of Scalp Electroencephalography and Magnetoencephalography During Production of Human Voluntary Movement
Status:
COMPLETED
Status Verified Date:
2010-11-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will use electroencephalography EEG to examine how the brain prepares for movement It will look at 1 what changes occur in a persons 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 eg 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
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 eg 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
Detailed Description:
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 15 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 ie 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 ALSPLS 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
Results from this study will then be used to design further protocols studying human voluntary movement and clinical applications as appropriate
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 ie 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 ALSPLS 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
Results from this study will then be used to design further protocols studying human voluntary movement and clinical applications as appropriate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-N-0109 | None | None | None |