Venous Irregularities, Flow and Perfusion in MS Study (VERIFYMS)
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| First Received Date ICMJE | May 6, 2012 | ||||||||
| Last Updated Date | May 6, 2012 | ||||||||
| Start Date ICMJE | January 2012 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | No Changes Posted | ||||||||
| 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 | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Venous Irregularities, Flow and Perfusion in MS Study | ||||||||
| Official Title ICMJE | Venous Irregularities, Flow and Perfusion in MS Study | ||||||||
| Brief Summary |
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| Detailed Description | The purpose of this study is to compare a MS subject to a non-MS, non-blood related subject. The 3D structural information provided by the protocol combined with the ability to observe and quantify flow through the major vessels of the neck, as well as the azygous vein, make it an ideal method for evaluating subjects' venous outflow. The protocol also has the potential to confirm the diagnosis of Multiple Sclerosis, observe any changes in the parenchyma, as well as provide data on any potential co-morbidity which may have been previously overlooked or non-emergent. The baseline scan data acquired on normal and pre-treatment MS patients can be tracked longitudinally for MSpatients for changes in: arterial and venous cross sectional area; morphological changes of vessels, brain structures, and lesions; flow distribution and flow patterns in arteries, veins, and cerebrospinal fluid (CSF); iron quantification in the deep basal ganglia and thalamus; parenchymal lesion volume and morphology; atrophy or ratio of gray matter, white matter; and CSF in the intracranial space; and appearance of intracranial veins and potential iron lesions in the parenchyma. A major benefit is that MRI is independent of operator bias and acquisition can be easily reproduced. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Human subjects will be approached for participation in this study that are receiving or seeking medical care at Synergy Health Concepts Inc. |
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| Condition ICMJE | Venous Irregularities, Flow and Perfusion in MS and Non-MS Participants | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||
| Estimated Completion Date | January 2013 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01593904 | ||||||||
| Other Study ID Numbers ICMJE | VERIFYMS | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Synergy Health Concepts, Inc. | ||||||||
| Study Sponsor ICMJE | Synergy Health Concepts, Inc. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Synergy Health Concepts, Inc. | ||||||||
| Verification Date | May 2012 | ||||||||
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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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