NCT00498329

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2011

Completed
Last Updated

July 2, 2017

Status Verified

November 18, 2011

First QC Date

July 7, 2007

Last Update Submit

June 30, 2017

Conditions

Keywords

fMRIElectroencephalogram (EEG)AttentionSensorimotor IntegrationHuman BrainHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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
  • 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)
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 8466179BACKGROUND
  • Singer 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.

    PMID: 7605074BACKGROUND
  • von der Malsburg C, Schneider W. A neural cocktail-party processor. Biol Cybern. 1986;54(1):29-40. doi: 10.1007/BF00337113.

    PMID: 3719028BACKGROUND

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 7, 2007

First Posted

July 10, 2007

Study Start

July 3, 2007

Study Completion

November 18, 2011

Last Updated

July 2, 2017

Record last verified: 2011-11-18

Locations