Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-31 @ 8:00 AM
Study NCT ID:
NCT01593904
Status:
UNKNOWN
Last Update Posted:
2012-05-08
First Post:
2012-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Venous Irregularities, Flow and Perfusion in MS Study
Sponsor:
Synergy Health Concepts, Inc.
Organization:
Study Overview
Official Title:
Venous Irregularities, Flow and Perfusion in MS Study
Status:
UNKNOWN
Status Verified Date:
2012-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VERIFYMS
Brief Summary:
1. What is the true incidence of CCSVI in patients with MS in a study comparing MRI on MS patients and controls.
2. Are the beneficial outcomes from treatment placebo? By measuring changes in brain perfusion and Cerebrospinal flow before and after the procedure on a large number of patients to determine these outcomes
2. Are the beneficial outcomes from treatment placebo? By measuring changes in brain perfusion and Cerebrospinal flow before and after the procedure on a large number of patients to determine these outcomes
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: