NCT00046215

Brief Summary

This study will use transcranial magnetic stimulation (TMS) to examine the relationship between cognitive processing and motor control by determining whether a part of the brain called the premotor cortex is essential to imagining movement. TMS, described below, is a method of brain stimulation that can temporarily inhibit brain functions of the area underlying the stimulator. Healthy right-handed normal volunteers may be eligible for this study. Candidates will be screened with a medical history, neurological examination, and test of finger dexterity. Participants will perform a sequential finger tapping movement in response to a series of numbers (stimuli) displayed on a computer monitor. After 10 stimuli, they will be asked which finger they tapped last. They will then imagine the same finger tapping movement and will be asked which finger they tapped last in their imagination. During these exercises, participants will undergo transcranial magnetic stimulation. For this procedure, the subject is seated comfortably in a chair. A wire coil is placed on the scalp and a brief electrical current is passed through the coil, creating a magnetic pulse that passes into the brain. This generates a very small electrical current in the brain, which briefly disrupts the function of the brain cells in the stimulated area. The stimulation may cause twitching in arm or leg muscles. During the stimulation, the electrical activity of muscles is recorded with a computer or other recording device, using electrodes attached to the skin with tape. Subjects will complete eight experimental blocks of testing. One block consists of 20 experimental trials, with each trial lasting about 10 seconds. Five pairs of TMS stimuli are given per trial, with pulses delivered in short bursts of one second each. After each block, subjects draw a mark on a line on paper, showing how much attention they are paying, how much fatigue they are experiencing, and how well they think they are executing the tasks. Each TMS session takes up to 3.5 hours. Before the TMS session, participants will undergo magnetic resonance imaging (MRI) for use in determining proper placement of the TMS coil. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. For this procedure, the subject lies still in a narrow metal cylinder (the scanner) for about 30 minutes during the scan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2002

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

September 1, 2002

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2002

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

November 1, 2003

First QC Date

September 21, 2002

Last Update Submit

March 3, 2008

Conditions

Keywords

Virtual Lesion StudyMotor ImageryPrimary Motor CortexMotor InhibitionMotor ExecutionHealthy Volunteer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • We will only recruit right-handed subjects as assessed by Edinburgh handedness inventory (Oldfield, 1971). We will also administer a simple version of the tapping task and assess their dexterity to select subjects consistent with the digit skills required.

You may not qualify if:

  • Contraindications for TMS: pacemakers, implanted medical pumps, metal plate in skull, metal objects inside the eye or skull, history of seizures.
  • Contraindications for MRI: pacemakers, brain stimulators, dental implants or metallic braces, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, insulin pump, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware. Subjects will be screened for these contraindications prior to the study.
  • Subjects with previous or current neuropsychiatric disorders will be excluded. Patients with MRI findings consistent with organic brain lesions such as brain tumors, stroke, or trauma will be excluded. Patients with a history of significant medical disorders such as cancers will be excluded. Subjects not capable of giving informed consent will be excluded.
  • We will not scan pregnant women with MRI because safety of high magnetic field to fetus is not established. Therefore, we will administer a urine pregnancy test for any female subject of childbearing potential prior to MRI scan.
  • Brain functions at a development stage are out of scope of this particular experiment, and, therefore, subjects under age 21 will be excluded.
  • Subjects who show evidence of unusually increased cortical excitability that may lead to seizure activity detected by surface EMG recording will be excluded from the study. Subjects who always reveal muscle activity during the motor imagery task will also be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Catalan MJ, Honda M, Weeks RA, Cohen LG, Hallett M. The functional neuroanatomy of simple and complex sequential finger movements: a PET study. Brain. 1998 Feb;121 ( Pt 2):253-64. doi: 10.1093/brain/121.2.253.

    PMID: 9549504BACKGROUND
  • Cohen LG, Weeks RA, Sadato N, Celnik P, Ishii K, Hallett M. Period of susceptibility for cross-modal plasticity in the blind. Ann Neurol. 1999 Apr;45(4):451-60. doi: 10.1002/1531-8249(199904)45:43.0.co;2-b.

    PMID: 10211469BACKGROUND
  • Classen J, Witte OW, Schlaug G, Seitz RJ, Holthausen H, Benecke R. Epileptic seizures triggered directly by focal transcranial magnetic stimulation. Electroencephalogr Clin Neurophysiol. 1995 Jan;94(1):19-25. doi: 10.1016/0013-4694(94)00249-k.

    PMID: 7530636BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

September 21, 2002

First Posted

September 23, 2002

Study Start

September 1, 2002

Study Completion

November 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-11

Locations