Brain ConnectivityNCT00498329
Brain Function in Performance of Motor Tasks
An observational study of Brain Connectivity, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine how the areas in the brain are connected when they are controlling two finger movements at the same time. It will look at how people use what they see to help guide two different movements. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Connectivity
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2007to 18 Nov 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects age from 18 to older.
- Subjects must be right-hand dominant (Edinburgh Handedness Quotient greater than 60), except if they are part of the control group to match left handed patients.
- Subjects willing to abstain from caffeine or alcohol for 48 hours prior to the fMRI scanning and MEG or EEG recording
- men and women aged 18 to 75 years with DOPA-responsive PD
- modified Hoehn and Yahr grade of 2 to 4 while OFF
- must be on a medical regimen that includes levodopa.
Show all 11Show fewer
- total dose of levodopa and dopamine agonists (using dopamine equivalents) has to be equal to or more than 300 milligrams per day
- patients willing to abstain from caffeine or alcohol for 48 hours prior to the fMRI scanning and MEG or EEG recording.
- Between 18 and 65 years old
- Diagnosed with focal hand dystonia
- patients willing to abstain from caffeine or alcohol for 48 hours prior to the fMRI scanning and MEG or EEG recording
Who cannot join
- Subjects with any abnormal findings on the neurological exam,
- Subjects who are pregnant (as determined by positive urine pregnancy test) which prevents them having an MRI
- Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
- Subjects with metallic dental fillings which are likely to cause MRI artifacts
- Subjects with any history of brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies
- Subjects with any history of a severe medical condition, such as cardiovascular disease, which would prevent them from lying flat for up to 120 minutes
Show all 38Show fewer
- Subjects without the capacity to give informed consent
- Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 90 minutes
- Patients with any abnormal findings on the neurological exam, with the exception of neurological findings consistent with Parkinson disease.
- any active psychiatric disease
- concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than anti-parkinsonian agents that could lower the seizure threshold except for SSRI
- history of pallidotomy
- presence of implanted electrodes and generator for deep brain stimulation
- the study would cause undue risk or stress for reasons such as excessive fatigue, general frailty, or excessive apprehensiveness.
- dementia as assessed by the Folstein's Mini Mental Test Examination (MMSE < 24/30) or mentally impaired patients having no capacity to provide their own consent (the physician establishing the diagnosis and applying UPDRS will evaluate patient's mental capacity using conventional clinical interview)
- Patients who are pregnant (as determined by positive urine pregnancy test) which prevents them having an MRI
- Patients with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
- Patients with metallic dental fillings which are likely to cause MRI artifacts
- Patients with surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during MRI.
- Patients with any history of brain tumor, stroke, seizures, head trauma or a vascular malformation as obtained by history or from imaging studies.
- Patients with a history of seizures and/or epilepsy
- Patients with any history of a severe medical condition other than PD, such as cardiovascular disease, which would prevent them from lying flat for up to 120 minutes
- Patients without the capacity to give informed consent
- Patients with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 90 minutes
- Patients with any abnormal findings on the neurological exam, with the exception of neurological findings consistent with Focal Hand dystonia
- Subjects with severe focal hand dystonia at rest.
- Patients with mirror dystonia
- Subjects who have had recent (within 3 months) Botulinum Toxin (Botox) injections
- Patients who are on anti-parkinsonian drugs
- Patients who are pregnant (as determined by positive urine pregnancy test) which prevents them having an MRI
- Patients with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
- Patients with metallic dental fillings which are likely to cause MRI artifacts
- Patients with surgically or traumatically implanted foreign bodies such as pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during MRI.
- Patients with any history or brain tumor, stroke, seizures, head trauma or a vascular malformation as obtained by history or from imaging studies
- Patients with a history of seizures and/or epilepsy
- Patients with any history of a severe medical condition, other than PD, such as cardiovascular disease, which will prevent them from lying flat for up to 120 minutes.
- Patients without the capacity to give informed consent
- Patients with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 90 minutes
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
Official title: Brain Connectivity and Sensorimotor Integration During Dual/Single Motor Tasks
This study will examine how the areas in the brain are connected when they are controlling two finger movements at the same time. It will look at how people use what they see to help guide two different movements. This ability, which is important in everyday life, can be a problem for patients with neurological problems.
Healthy right-handed volunteers 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, physical examination and magnetic resonance imaging (MRI) of the brain. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. The subject lies on a table that can slide in and out of the scanner, wearing earplugs to muffle loud noises that occur during the scanning.
Read more
Participants undergo functional MRI (fMRI). This is a standard MRI that is done while the subject performs skilled finger tasks in response to instructions they see on a screen. Researchers localize brain areas which show activity changes while the tasks are performed. Before the test session begins, subjects complete a questionnaire and have an opportunity to practice the task.
Subjects control the position of one or two cursors on a screen using one or two fingers. They perform tracking or pointing tasks according to what they see on the screen. During the single-task experiment only one task is presented on the screen. During the dual-task experiment, two tasks are presented on the screen. Subjects perform either the single-task or dual-task experiment, but not both. The fMRI lasts about 90 minutes, with subjects asked to lie still during the scan for up to 9 minutes at a time.
After completing the fMRI, subjects are scheduled for a research electroencephalogram (EEG) and magnetoencephalogram (MEG). The test is done while the subject performs tasks so that researchers can learn about the timing of changes in activity in certain brain regions during performance of the same tasks done for the fMRI.
Read the detailed description
Objective
Using a block design BOLD-fMRI, we want to investigate the connectivity in brain regions when two motor responses are performed in the same time. The designs will be replicated using EEG and MEG to understand the time course of the activated brain network better. It will allow us to map the brain processes involved in sensorimotor integration and attentional sharing.
Study Population
160 individuals subdivided in:
- 110 adult healthy volunteers
- 25 patients with Parkinson Disease
- 25 patients with Focal Hand Dystonia
Design
Two experiments will be performed using MEG, EEG and fMRI techniques. Both experiments will use visuo-motor control tasks. Two motor responses (given by two fingers of the dominant hand) will be simultaneously performed. Experiment 1 will use single motor tasks; Experiment 2 will use dual motor tasks. In both experiments, the attention demands will vary with the execution mode of the motor outputs (competitive or cooperative). In competitive tasks, the visual stimuli will be used to perform two independent motor outputs. In cooperative tasks, the visual stimuli will be used to perform two coupled motor outputs. The effect of the execution mode on brain connectivity will be isolated comparing competitive and cooperative tasks. The sensory information must be associated to the motor command to perform a given motor task: this process is called sensorimotor integration. With both experiments, we will be able to dissociate the network connectivity linked to:
- sensorimotor integration demands for focused attention in a single task,
- sensorimotor integration demands for divided attention in a dual motor task.
After subjects have been properly trained to perform the tasks, they will undergo fMRI scanning MEG and EEG recording. Subjects will perform the tasks presented pseudo-randomly during six sets of 5-minute sessions. We will record their muscular activity via EMG surface electrodes.
Outcome Measures
The primary outcomes are the task-dependent functional connectivity (for fMRI) between areas and coherence (for MEG and EEG) of cerebral sources relative to performance of the tasks. The force control of two fingers in the same time would elicit blood oxygen level dependent (BOLD) signal and electrical brain activity variations in the network involved in manual dexterity. We are interested in studying the connectivity between the homologous motor areas of the two hemispheres, and between prefrontal cortex and parietal cortex, to understand sensorimotor integration processes during competitive and cooperative dual tasks. As a second measure, we are interested in analyzing coherence between MEG-EMG and EEG-EMG signals.
- Conditions
- Brain Connectivity
- Keywords
- fMRI, Electroencephalogram (EEG), Attention, Sensorimotor Integration, Human Brain, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study start3 Jul 2007
- Study completion18 Nov 2011
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 Brain ConnectivityStudies of the same condition, open and under way.
- 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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498329
- Sponsor's protocol ID
- 070187
- Other IDs
- 07-N-0187
- Status last verified
- 18 Nov 2011
- First submitted
- 7 Jul 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Singer W. Synchronization of cortical activity and its putative role in information processing and learning. Annu Rev Physiol. 1993;55:349-74. doi: 10.1146/annurev.ph.55.030193.002025. No abstract available.
PubMed 8466179Singer W, Gray CM. Visual feature integration and the temporal correlation hypothesis. Annu Rev Neurosci. 1995;18:555-86. doi: 10.1146/annurev.ne.18.030195.003011. No abstract available.
PubMed 7605074von der Malsburg C, Schneider W. A neural cocktail-party processor. Biol Cybern. 1986;54(1):29-40. doi: 10.1007/BF00337113.
PubMed 3719028
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
- Brain Connectivity and Sensorimotor Integration During Dual/Single Motor Tasks
- ClinicalTrials.gov ID
- NCT00498329
- Acronym / sponsor ID
- 070187
- Conditions
- Brain Connectivity
- Keywords
- fMRI, Electroencephalogram (EEG), Attention, Sensorimotor Integration, Human Brain, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 3 Jul 2007
- Study completion
- 18 Nov 2011
- First posted
- 10 Jul 2007 (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.
This study will examine how the areas in the brain are connected when they are controlling two finger movements at the same time. It will look at how people use what they see to help guide two different movements. This ability, which is important in everyday life, can be a problem for patients with neurological problems.
Healthy right-handed volunteers 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, physical examination and magnetic resonance imaging (MRI) of the brain. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. The subject lies on a table that can slide in and out of the scanner, wearing earplugs to muffle loud noises that occur during the scanning.
Participants undergo functional MRI (fMRI). This is a standard MRI that is done while the subject performs skilled finger tasks in response to instructions they see on a screen. Researchers localize brain areas which show activity changes while the tasks are performed. Before the test session begins, subjects complete a questionnaire and have an opportunity to practice the task.
Subjects control the position of one or two cursors on a screen using one or two fingers. They perform tracking or pointing tasks according to what they see on the screen. During the single-task experiment only one task is presented on the screen. During the dual-task experiment, two tasks are presented on the screen. Subjects perform either the single-task or dual-task experiment, but not both. The fMRI lasts about 90 minutes, with subjects asked to lie still during the scan for up to 9 minutes at a time.
After completing the fMRI, subjects are scheduled for a research electroencephalogram (EEG) and magnetoencephalogram (MEG). The test is done while the subject performs tasks so that researchers can learn about the timing of changes in activity in certain brain regions during performance of the same tasks done for the fMRI.
Detailed description
Objective
Using a block design BOLD-fMRI, we want to investigate the connectivity in brain regions when two motor responses are performed in the same time. The designs will be replicated using EEG and MEG to understand the time course of the activated brain network better. It will allow us to map the brain processes involved in sensorimotor integration and attentional sharing.
Study Population
160 individuals subdivided in:
- 110 adult healthy volunteers
- 25 patients with Parkinson Disease
- 25 patients with Focal Hand Dystonia
Design
Two experiments will be performed using MEG, EEG and fMRI techniques. Both experiments will use visuo-motor control tasks. Two motor responses (given by two fingers of the dominant hand) will be simultaneously performed. Experiment 1 will use single motor tasks; Experiment 2 will use dual motor tasks. In both experiments, the attention demands will vary with the execution mode of the motor outputs (competitive or cooperative). In competitive tasks, the visual stimuli will be used to perform two independent motor outputs. In cooperative tasks, the visual stimuli will be used to perform two coupled motor outputs. The effect of the execution mode on brain connectivity will be isolated comparing competitive and cooperative tasks. The sensory information must be associated to the motor command to perform a given motor task: this process is called sensorimotor integration. With both experiments, we will be able to dissociate the network connectivity linked to:
- sensorimotor integration demands for focused attention in a single task,
- sensorimotor integration demands for divided attention in a dual motor task.
After subjects have been properly trained to perform the tasks, they will undergo fMRI scanning MEG and EEG recording. Subjects will perform the tasks presented pseudo-randomly during six sets of 5-minute sessions. We will record their muscular activity via EMG surface electrodes.
Outcome Measures
The primary outcomes are the task-dependent functional connectivity (for fMRI) between areas and coherence (for MEG and EEG) of cerebral sources relative to performance of the tasks. The force control of two fingers in the same time would elicit blood oxygen level dependent (BOLD) signal and electrical brain activity variations in the network involved in manual dexterity. We are interested in studying the connectivity between the homologous motor areas of the two hemispheres, and between prefrontal cortex and parietal cortex, to understand sensorimotor integration processes during competitive and cooperative dual tasks. As a second measure, we are interested in analyzing coherence between MEG-EMG and EEG-EMG signals.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subjects age from 18 to older.
- Subjects must be right-hand dominant (Edinburgh Handedness Quotient greater than 60), except if they are part of the control group to match left handed patients.
- Subjects willing to abstain from caffeine or alcohol for 48 hours prior to the fMRI scanning and MEG or EEG recording
- men and women aged 18 to 75 years with DOPA-responsive PD
- modified Hoehn and Yahr grade of 2 to 4 while OFF
Key exclusion criteria (38 listed)
- Subjects with any abnormal findings on the neurological exam,
- Subjects who are pregnant (as determined by positive urine pregnancy test) which prevents them having an MRI
- Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
- Subjects with metallic dental fillings which are likely to cause MRI artifacts
- Subjects with any history of brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 8466179Singer W. Synchronization of cortical activity and its putative role in information processing and learning. Annu Rev Physiol. 1993;55:349-74. doi: 10.1146/annurev.ph.55.030193.002025. No abstract available.
- Background: PubMed 7605074Singer W, Gray CM. Visual feature integration and the temporal correlation hypothesis. Annu Rev Neurosci. 1995;18:555-86. doi: 10.1146/annurev.ne.18.030195.003011. No abstract available.
- Background: PubMed 3719028von der Malsburg C, Schneider W. A neural cocktail-party processor. Biol Cybern. 1986;54(1):29-40. doi: 10.1007/BF00337113.
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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 Brain Connectivity, 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 11 inclusion and 38 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT00498329, 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.