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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 10, 2004 |
| Last Updated Date | August 21, 2008 |
| Start Date ICMJE | November 2004 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE |
A change in the mean linear rate of decline of the estimated calculated glomerular filtration rate (GFR). |
| Change History | Complete list of historical versions of study NCT00096564 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE |
Globotriaosylceramide (Gb(3)) in plasma and urinary sediment, quantitative sudomotor axon reflex test, quantitative sensory testing and Doppler skin blood flow. |
| Descriptive Information | |
| Brief Title ICMJE | Brain Activities Associated With Different Facial Expressions Using Blood Oxygenation Level Dependent Functional MRI |
| Official Title ICMJE | Functional MRI Study of Brain Activation With Observation of Facial Expressions |
| Brief Summary | Objectives: The purpose of this study is to identify areas of brain activation during the urge to yawn. Little is known about how yawning is suppressed, or why yawning often occurs in response to seeing another person yawn (contagious yawning). Contagious yawning is similar to other contagious motor programs, such as the greater urge Tourette subjects feel to tic when seeing repetitive movements or other subjects' tics, the urge to scratch when discussing itching and scratching, or the urge to urinate when hearing running water. Hypothetically, the urge or the suppression of this urge is modulated by a common cortical circuit implicated in Tourette syndrome. We plan to use functional magnetic resonance imaging (fMRI) to identify the pattern of blood oxygenation level-dependent (BOLD) activation in the brain when normal volunteers feel the urge to yawn. Study Population: We intend to study 25 normal, right-handed, healthy volunteers. Study Design: Using an event-related design, we will scan subjects, using the same 3T fMRI scanner, while showing a video of a person yawning, gaping, coughing, or doing nothing. Each of these four action stimuli will last for four seconds, with varying interstimulus intervals. Each video set will contain all actions displayed ten times pseudorandomly. Two data sets will be collected from each subject and will be separated by a brief rest period. Subjects will be instructed before the scan to watch a videotaped person perform various behaviors, without detailing the specific actions. So as not to influence their natural response to the yawning stimulus, we will instruct them only to keep their head still. The variable of interest will be the activation during urge-generation, contrasted with other control stimuli. A survey will be administered for informational purposes following the scan to assess the subjects' general impression of their susceptibility to yawning, whether they yawned in the scanner, whether they suppressed the urge to yawn, and if the urge to yawn increased or decreased with the repetition of the yawning segment. Outcome Measures: The primary outcome of this study is the activation of brain structures in response to viewing another person yawning. In particular, we are interested in the activation of the anterior cingulate cortex, parietal operculum, insula, supplementary motor area, and dorsolateral prefrontal cortex as these are areas implicated in the urge to move in response to either internal (as in Tourette syndrome) or external (as in itching from histamine injection) states. Since the urge to yawn is the process of interest, suppression of yawning is not relevant to the fMRI analysis. |
| Detailed Description | Purpose of this study This study will look at how perception and observation of various facial expressions may affect the way different areas of the brain function. We hope to gain a greater understanding of abnormal movements, such as tics, by investigating how facial expressions affect the brain. Background Information This study is based on prior research that focuses on the activity and changes in different areas of the brain depending on what people see others around them doing. An example is the feeling of empathy one might have when looking at a sad face, or anxiety and fear when looking at an angry face. Who is the Study Population? 20 healthy, right-handed men and women |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE | Healthy |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 25 |
| Completion Date | August 2008 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
Subjects age 18 and older. Subjects willing to abstain from caffeine or alcohol for 48 hours prior to the fMRI scanning. EXCLUSION CRITERIA: Subjects with any abnormal findings on neurological exam. Subjects with a positive urine pregnancy test. Subjects who are pregnant. Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan. Subjects with any history of brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies. Subjects with any history of a severe medical condition, such as cardiovascular disease, which would prevent them from lying flat for up to 60 minutes. Subjects without the capacity to give informed consent. Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 60 minutes. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00096564 |
| Responsible Party | |
| Study ID Numbers ICMJE | 050032, 05-N-0032 |
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | August 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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