Ignite Creation Date:
2024-05-05 @ 10:37 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01143506
Status:
WITHDRAWN
Last Update Posted:
2017-07-02
First Post:
2010-06-11
Brief Title:
Physiology of Volition Studied With Nerve Block
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Physiology of Volition Studied With Nerve Block
Status:
WITHDRAWN
Status Verified Date:
2012-01-04
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:
Background
- The experience of volition that accompanies voluntary movement can be divided into the sense of will or deciding to move and the sense of agency or feeling that the movement just made was self-generated Very little is known regarding the neurological origin of this sense of volition Previous research has shown that a particular part of the brain the parietal lobe is involved in our inner sense that we control the movements we make Researchers are interested in determining if this sense relies on sensory information from moving fingers reaching the parietal lobe
Objectives
- To determine the brain regions responsible for the sense of volition and the associated sense of agency
Eligibility
- Healthy right-handed individuals between 18 and 55 years of age
Design
The study will involve a screening visit and two testing visits The screening visit will last 30 minutes to 1 hour and the testing visits will each last 3 to 4 hours
Participants will be screened with a physical examination and medical history
At each testing visit participants will have a brain magnetic resonance imaging MRI scan electroencephalography EEG and electromyography EMG The MRI scan and EEG will be done during a movement task that involves the thumb second finger and fifth finger of one hand EMG will be used to monitor movements and muscle activity
During the second testing visit participants will receive a nerve block using anesthetic followed by the MRI EEG EMG and movement task The nerve block will temporarily numb and prevent the movement of parts of the hand and fingers
After the MRI scan and EEG recording participants will be asked to rate how much control they felt they had over choosing whether to move and how much control they felt they had in actually making the movements
- The experience of volition that accompanies voluntary movement can be divided into the sense of will or deciding to move and the sense of agency or feeling that the movement just made was self-generated Very little is known regarding the neurological origin of this sense of volition Previous research has shown that a particular part of the brain the parietal lobe is involved in our inner sense that we control the movements we make Researchers are interested in determining if this sense relies on sensory information from moving fingers reaching the parietal lobe
Objectives
- To determine the brain regions responsible for the sense of volition and the associated sense of agency
Eligibility
- Healthy right-handed individuals between 18 and 55 years of age
Design
The study will involve a screening visit and two testing visits The screening visit will last 30 minutes to 1 hour and the testing visits will each last 3 to 4 hours
Participants will be screened with a physical examination and medical history
At each testing visit participants will have a brain magnetic resonance imaging MRI scan electroencephalography EEG and electromyography EMG The MRI scan and EEG will be done during a movement task that involves the thumb second finger and fifth finger of one hand EMG will be used to monitor movements and muscle activity
During the second testing visit participants will receive a nerve block using anesthetic followed by the MRI EEG EMG and movement task The nerve block will temporarily numb and prevent the movement of parts of the hand and fingers
After the MRI scan and EEG recording participants will be asked to rate how much control they felt they had over choosing whether to move and how much control they felt they had in actually making the movements
Detailed Description:
OBJECTIVE
The primary objective of this study is to determine the brain regions responsible for the sense of volition and the associated sense of agency Nerve blocks will be used to interfere with movement andor sensory feedback from movement
STUDY POPULATION
Healthy subjects
DESIGN
The initial studies will evaluate brain activity during the attempt to move different fingers after ulnar nerve block using functional magnetic resonance imaging fMRI electroencephalography EEG and surface electromyography EMG Subjects will attempt to move their fifth finger their second finger and the thumb These fingers will also be moved by the experimenter as a passive condition The paradigm will be done once without anesthesia and once after ulnar nerve block For both fMRI EEG and EMG analysis will be done with single event design As our primary outcome we hypothesize that subtracting the activation associated with attempting to move a paralyzed and anesthetized 5th finger as well as the activation associated with the passive movement of the 5th finger without anesthesia from that of normal movement of the same finger without anesthesia will show activation remaining in the inferior parietal lobule which may be the area responsible for the feeling of agency The activation associated with the attempt to move second finger which will be paralyzed but only partially anesthetized will be a secondary outcome of this study as will other subtractions of activation associated with the three fingers
OUTCOME MEASURES
fMRI Comparison of the BOLD signal in different brain regions with the different finger movements or attempted finger movements The primary outcome measure is the difference in BOLD activation in the inferior parietal lobule between that associated with the attempt to move the 5th finger after anesthesia compared to the activation associated with moving the 5th finger actively minus the 5th finger being moved passively with no anesthesia Restated from the trial with no anesthesia the activation of active 5th finger movement which reflects will W motor program P sensory feedback S and agency A minus passive 5th finger movement which reflects S only will be compared to the activation from the attempt to move the 5th finger after ulnar block which reflects W and P only By comparing WPSA minus S to WP in the region of the inferior parietal lobule we expect to see the activation associated with A agency
EEGEMG Movement-related cortical potentials will be compared with the different finger movements using EMG to mark the onset of movement these will be secondary outcomes
The primary objective of this study is to determine the brain regions responsible for the sense of volition and the associated sense of agency Nerve blocks will be used to interfere with movement andor sensory feedback from movement
STUDY POPULATION
Healthy subjects
DESIGN
The initial studies will evaluate brain activity during the attempt to move different fingers after ulnar nerve block using functional magnetic resonance imaging fMRI electroencephalography EEG and surface electromyography EMG Subjects will attempt to move their fifth finger their second finger and the thumb These fingers will also be moved by the experimenter as a passive condition The paradigm will be done once without anesthesia and once after ulnar nerve block For both fMRI EEG and EMG analysis will be done with single event design As our primary outcome we hypothesize that subtracting the activation associated with attempting to move a paralyzed and anesthetized 5th finger as well as the activation associated with the passive movement of the 5th finger without anesthesia from that of normal movement of the same finger without anesthesia will show activation remaining in the inferior parietal lobule which may be the area responsible for the feeling of agency The activation associated with the attempt to move second finger which will be paralyzed but only partially anesthetized will be a secondary outcome of this study as will other subtractions of activation associated with the three fingers
OUTCOME MEASURES
fMRI Comparison of the BOLD signal in different brain regions with the different finger movements or attempted finger movements The primary outcome measure is the difference in BOLD activation in the inferior parietal lobule between that associated with the attempt to move the 5th finger after anesthesia compared to the activation associated with moving the 5th finger actively minus the 5th finger being moved passively with no anesthesia Restated from the trial with no anesthesia the activation of active 5th finger movement which reflects will W motor program P sensory feedback S and agency A minus passive 5th finger movement which reflects S only will be compared to the activation from the attempt to move the 5th finger after ulnar block which reflects W and P only By comparing WPSA minus S to WP in the region of the inferior parietal lobule we expect to see the activation associated with A agency
EEGEMG Movement-related cortical potentials will be compared with the different finger movements using EMG to mark the onset of movement these will be secondary outcomes
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 |
|---|---|---|---|
| 10-N-0131 | None | None | None |