Brain Use of Sensory Information to Generate Movement
|First Received Date ICMJE||February 22, 2003|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||February 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00055289 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Brain Use of Sensory Information to Generate Movement|
|Official Title ICMJE||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.
The role of multimodal brain regions for sensory-to-motor processing is not well understood. In our recent neuroimaging study with fMRI, we found that multimodal areas such as the right superior temporal cortex and right dorsal premotor cortex were activated during sensory instructed movements. These regions might contribute to extract common features or concepts from sensory stimuli, but we do not have firm experimental evidence yet. In order to investigate the functional roles of multimodal brain regions further, we propose to apply a transcranial magnetic stimulation (TMS) technique. TMS can create transient brain lesions allowing functional mapping of cortical regions. In this protocol, by stimulating the multimodal areas using TMS, we will determine the functional role of these areas.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||January 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
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.
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00055289|
|Other Study ID Numbers ICMJE||030112, 03-N-0112|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 2006|
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