Healthy VolunteersNCT01143506
Physiology of Volition Studied With Nerve Block
An observational study of Healthy Volunteers, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2010to 4 Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy right-handed subjects ranging from 18 to 55 will be included. All subjects should have a valid Clinical Center Medical Record Number.
Who cannot join
- Healthy subjects younger than 18 years and older than 55 will be excluded.
- Subjects with MRI findings consistent with organic brain lesions such as brain tumors, stroke, trauma or AVMs will be excluded.
- Subjects with active significant medical or neurological disorders, or active Axis I psychiatric disorders, or requiring continuous treatment with drugs that affect the central nervous system will be excluded.
- We will not include pregnant women because safety of high magnetic field to fetus is not established.
- Subjects allergic to local anesthetics such as bupivacaine will be excluded.
- Subjects unable to have an MRI due to claustrophobia or contraindications to MR scanning will be excluded.
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- Subjects who are left-handed will be excluded.
- Subjects will be excluded who are taking anticoagulant or antiplatelet medications such as warfarin, heparin, clopidogrel, ticlopidine, or fondiparinux, or vitamin E in amounts greater than 1600 IU per day.
- If subjects are taking daily aspirin therapy, this must be held for 7 days prior to the nerve block. If subjects are taking daily NSAIDs, these must be held for 12 hours prior to the nerve block. If these medications cannot be held for these periods, the subject will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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 and/or 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 (W+P+S+A minus S) to (W+P) in the region of the inferior parietal lobule, we expect to see the activation associated with A, agency.
EEG/EMG: 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.
- Conditions
- Healthy Volunteers
- Keywords
- Sense of Agency, Ulnar Nerve Block, Healthy Volunteer, fMRI, EEG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study start1 Jun 2010
- Study completion4 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143506
- Sponsor's protocol ID
- 100131
- Other IDs
- 10-N-0131
- Status last verified
- 4 Jan 2012
- First submitted
- 11 Jun 2010
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Blakemore SJ, Oakley DA, Frith CD. Delusions of alien control in the normal brain. Neuropsychologia. 2003;41(8):1058-67. doi: 10.1016/s0028-3932(02)00313-5.
PubMed 12667541Libet B, Gleason CA, Wright EW, Pearl DK. Time of conscious intention to act in relation to onset of cerebral activity (readiness-potential). The unconscious initiation of a freely voluntary act. Brain. 1983 Sep;106 (Pt 3):623-42. doi: 10.1093/brain/106.3.623.
PubMed 6640273Deecke L, Kornhuber HH. An electrical sign of participation of the mesial 'supplementary' motor cortex in human voluntary finger movement. Brain Res. 1978 Dec 29;159(2):473-6. doi: 10.1016/0006-8993(78)90561-9. No abstract available.
PubMed 728816
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology of Volition Studied With Nerve Block
- ClinicalTrials.gov ID
- NCT01143506
- Acronym / sponsor ID
- 100131
- Conditions
- Healthy Volunteers
- Keywords
- Sense of Agency, Ulnar Nerve Block, Healthy Volunteer, fMRI, EEG
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 1 Jun 2010
- Study completion
- 4 Jan 2012
- First posted
- 14 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 and/or 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 (W+P+S+A minus S) to (W+P) in the region of the inferior parietal lobule, we expect to see the activation associated with A, agency.
EEG/EMG: 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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy right-handed subjects ranging from 18 to 55 will be included. All subjects should have a valid Clinical Center Medical Record Number.
Key exclusion criteria (9 listed)
- Healthy subjects younger than 18 years and older than 55 will be excluded.
- Subjects with MRI findings consistent with organic brain lesions such as brain tumors, stroke, trauma or AVMs will be excluded.
- Subjects with active significant medical or neurological disorders, or active Axis I psychiatric disorders, or requiring continuous treatment with drugs that affect the central nervous system will be excluded.
- We will not include pregnant women because safety of high magnetic field to fetus is not established.
- Subjects allergic to local anesthetics such as bupivacaine will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 12667541Blakemore SJ, Oakley DA, Frith CD. Delusions of alien control in the normal brain. Neuropsychologia. 2003;41(8):1058-67. doi: 10.1016/s0028-3932(02)00313-5.
- Background: PubMed 6640273Libet B, Gleason CA, Wright EW, Pearl DK. Time of conscious intention to act in relation to onset of cerebral activity (readiness-potential). The unconscious initiation of a freely voluntary act. Brain. 1983 Sep;106 (Pt 3):623-42. doi: 10.1093/brain/106.3.623.
- Background: PubMed 728816Deecke L, Kornhuber HH. An electrical sign of participation of the mesial 'supplementary' motor cortex in human voluntary finger movement. Brain Res. 1978 Dec 29;159(2):473-6. doi: 10.1016/0006-8993(78)90561-9. No abstract available.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01143506, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.