Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
108 participants
OBSERVATIONAL
2005-07-08
2007-06-25
Brief Summary
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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.
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Detailed Description
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We will use a longitudinal design that will include three exercise groups. In 20 sessions over 4 weeks, subjects will strengthen their first dorsal interosseus (FDI) muscle of the dominant hand either with voluntary, electrically stimulated, or imagined contractions. The design also includes three control groups, a sham-stimulated group, a repetitive transcranial magnetic stimulation (1HzTMS) group, and a no-intervention group. Before and after the training programs, we will determine the changes in the outcome measures, including voluntary and electrical stimulation evoked force of the trained and the untrained FDI. Measures of excitability of the involved and uninvolved motor cortex, assessed with TMS, and measures of spinal cord excitability, assessed with peripheral nerve stimulation, are the additional outcome measures. The results of these studies will substantially increase our understanding of central nervous system (CNS) control of voluntary movement in health and disease.
Conditions
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. neurological impairments, including current or past peripheral or central nervous system dysfunction
3. being on drugs that may lower the seizure threshold
4. 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)
5. consumption of more than moderate amounts of alcohol or caffeine
18 Years
60 Years
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
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References
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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.
Other Identifiers
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05-N-0188
Identifier Type: -
Identifier Source: secondary_id
050188
Identifier Type: -
Identifier Source: org_study_id
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