- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00055289
Brain Use of Sensory Information to Generate Movement
Role of Multimodal Areas for Sensory-To-Motor Processing
This study will use transcranial magnetic stimulation (TMS) to investigate functions of brain regions that may use information from sensory organs, such as the eyes or ears, to generate movements.
For TMS, a wire coil is held over the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. This may cause a pulling sensation on the skin under the coil and twitching in muscles of the face, arm, or leg. During the stimulation, the participant may be asked to tense certain muscles slightly or perform other simple actions.
Healthy normal volunteers 18 years of age and older may be eligible for this study. Individuals with a history of neuropsychiatric disorders, brain lesions such as tumors, stroke, or trauma, or a history of significant medical disorders, such as cancer, may not participate. Candidates will be screened with a medical history, brief physical examination, and questionnaire.
Participants will be presented a sequence of shapes (circles, rectangles, and triangle) and will count the number of a specified shape. Each number is assigned to a corresponding response button. The subject will push the appropriate button with the corresponding finger. During these experiments, the scalp will be stimulated by TMS. Each set of TMS measurements will take up to 3-1/2 hours.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Forty normal volunteers will be included. Normal volunteers would be recruited from people who are registered as HMCS Normal Volunteers. All subjects participating in this study should have a valid Clinical Center Medical Record Number. Procedures for the experiment will follow the Standard Operating Procedures of HMCS TMS group.
EXCLUSION CRITERIA:
Contraindications for TMS;
Magnetic stimulation will not be performed in people who have pacemakers, implanted pumps or stimulators, or have metal objects inside the eye or skull. If the participants find the procedures too uncomfortable, they may discontinue the study at any time. Brain functions at a development stage are out of scope of this particular experiment. In this study, subjects 18 years or older will be included.
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 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. 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 developmental stage are out of scope of this particular experiment. In this study, subjects aged 18 years or older will be included.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403. doi: 10.1212/wnl.48.5.1398.
- Bremmer F, Schlack A, Shah NJ, Zafiris O, Kubischik M, Hoffmann K, Zilles K, Fink GR. Polymodal motion processing in posterior parietal and premotor cortex: a human fMRI study strongly implies equivalencies between humans and monkeys. Neuron. 2001 Jan;29(1):287-96. doi: 10.1016/s0896-6273(01)00198-2.
- Calvert GA. Crossmodal processing in the human brain: insights from functional neuroimaging studies. Cereb Cortex. 2001 Dec;11(12):1110-23. doi: 10.1093/cercor/11.12.1110.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 030112
- 03-N-0112
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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