NCT00120666

Brief Summary

This study will determine how the brain controls movements by sending messages to the spinal cord and muscles. Researchers want to know if strengthening a hand muscle will increase the strength of the same muscle in the other hand, and if these changes happen in the brain or spine, or both. Plasticity in this study refers to the capacity for continuous changes of the neural pathways in the brain and nervous system. Researchers have seen cases in which using a muscle extensively (force production) in one muscle group has increased the strength of the same muscle group on the opposite side of the body (force transfer). This situation happens without the unused muscle becoming larger-suggesting that the practice causes changes in some parts of the brain or spine. It is vital for scientists to know how this effect works, so that they can create new rehabilitation methods for people who cannot move or who have difficulty moving one side of their body. Patients ages 18 to 60 who are in good health and who do not have a history of major conditions affecting the bones, joints or nervous system may be eligible for this study. Patients will undergo a medical examination. There will be 1 or 2 testing sessions, 20 training sessions, and 1 or 2 final testing sessions, with patients being asked to come to the laboratory for as few as 4 times (about 10 hours total) or for up to 25 visits (about 20 hours total). The investigator will indicate which of six different groups that a patient is selected for. During testing sessions, the strength of the pointer and little fingers in each hand will be determined through the use of very brief electrical pulses. There also will be transcranial magnetic stimulation (TMS) and 1 Hz TMS. The researchers will place one or two wire coils on the patient's scalp and make marks on the scalp which will be removed at the end of the session. During the TMS, a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. Patients will hear a click sound and feel a snapping sensation on the skin. They may also feel and see small twitches in the hand muscles, and the fingers or wrist may move. There will be a total of about 300 magnetic stimuli, at a rate of 10 pulses per minute. Patients will also have an electromyogram (EMG), a procedure recording electrical activity in the muscles that are activated by electrical or magnetic stimulation. Metal electrodes will be attached to the skin over the muscle. During the EMG, patients will be asked to tense certain muscles slightly. Depending on the group a patient is assigned to, he or she may be asked to use the right index finger by using voluntary muscle movement, electrical stimulation, his or her imagination, electrical stimulation of a different hand muscle, or voluntary movements immediately followed by repetitive TMS. Regardless of group assignment, there will be five blocks of 10 repetitions of finger exercise per session, 200 per week, and 1,000 throughout the whole study. During the study sessions, patients will be able to talk and move around. They can take a break and leave the room if needed. In most cases, the session will take less than 2 hours. There also will be a control group whose members will not be training their fingers but who will participate only in the testing sessions. TMS is a safe procedure; however, strong contractions of scalp muscles have been known to cause headaches. Also, because of the distracting noise of the TMS, patients will be fitted with earplugs to wear during the procedure. Compensation for research-related discomfort and inconvenience will be made to participants, with a maximum of $500 to $600, depending on assignment to groups. This study will not have a direct benefit for participants. However, researchers hope to gain information that will help them better understand how the two sides of the brain control movement and how they affect each other regarding movement control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2007

Completed
Last Updated

July 2, 2017

Status Verified

June 25, 2007

First QC Date

July 16, 2005

Last Update Submit

June 30, 2017

Conditions

Keywords

ExerciseStimulationNerveElectricalMuscleHealthy VolunteerHV

Eligibility Criteria

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

You may qualify if:

  • Male and female volunteers ages 18-60 years old will qualify for this study. The subject population will be equitable and we will strive to enroll volunteers from all ethnic backgrounds.

You may not qualify if:

  • orthopedic impairments of the upper extremities
  • neurological impairments, including current or past peripheral or central nervous system dysfunction
  • being on drugs that may lower the seizure threshold
  • having a pacemaker, an implanted medication pump, a metal plate in the skull, metal objects in the eye or skull (for example after brain surgery or shrapnel wounds)
  • consumption of more than moderate amounts of alcohol or caffeine

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 (1)

  • ASANUMA H, OKUDA O. Effects of transcallosal volleys on pyramidal tract cell activity of cat. J Neurophysiol. 1962 Mar;25:198-208. doi: 10.1152/jn.1962.25.2.198. No abstract available.

    PMID: 13862744BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

July 16, 2005

First Posted

July 18, 2005

Study Start

July 8, 2005

Study Completion

June 25, 2007

Last Updated

July 2, 2017

Record last verified: 2007-06-25

Locations