Brain Function in Performance of Motor Tasks

June 30, 2017 updated by: National Institute of Neurological Disorders and Stroke (NINDS)

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Inclusion Criteria for Healthy Volunteers

  • 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

Inclusion Criteria for PD Patients

  • 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.
  • 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.

Inclusion Criteria for FHD Patients

  • 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

EXCLUSION CRITERIA:

Exclusion Criteria for Healthy Volunteers

  • 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
  • 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

Exclusion Criteria for PD Patients

  • 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

Exclusion Criteria for FHD patients

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2007

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2007

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 18, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 070187
  • 07-N-0187

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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