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Venous Irregularities, Flow and Perfusion in MS Study (VERIFYMS)

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ClinicalTrials.gov Identifier: NCT01593904
Recruitment Status : Unknown
Verified May 2012 by Synergy Health Concepts, Inc..
Recruitment status was:  Recruiting
First Posted : May 8, 2012
Last Update Posted : May 8, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease
Venous Irregularities, Flow and Perfusion in MS and Non-MS Participants

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 Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Venous Irregularities, Flow and Perfusion in MS Study
Study Start Date : January 2012
Estimated Study Completion Date : January 2013
Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • Ability to comprehend the nature of the study, including the risks and benefits
  • Ability to execute an informed consent
  • Males or Females between the ages of 20 and 65 years of age
  • Voluntary agreement to participate in the study: Venous Irregularities, Flow and Perfusion in MS study (VERIFY MS Study)

Exclusion Criteria:

  • Any implantable/metallic objects that prevents subject from having a magnetic resonance imaging (MRI/MRV) study.
  • Any person who has a contraindication to contrast administration.
  • History of claustrophobia
  • Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women, fetuses, and cognitively impaired individuals who are unable to provide informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593904


Contacts
Contact: Frances Debarge- Igoe, RN (949) 221-0129 uscangionurse@gmail.com
Contact: John Joseph Hewett, MD (949) 221-0129 jhewett@synergyhealthconcepts.com

Locations
United States, California
Synergy Health Concepts Inc. Recruiting
Newport Beach, California, United States, 92660
Contact: Frances Debarge-Igoe, RN    949-221-0129    uscangionurse@aol.com   
Contact: John Joseph Hewett, MD    (949) 221-0129    jhewett@synergyhealthconcepts.com   
Principal Investigator: John Joseph Hewett, MD         
Sponsors and Collaborators
Synergy Health Concepts, Inc.
Investigators
Principal Investigator: John Joseph Hewett, MD Study Principal Investigator
More Information

Additional Information:
Responsible Party: Synergy Health Concepts, Inc.
ClinicalTrials.gov Identifier: NCT01593904     History of Changes
Other Study ID Numbers: VERIFYMS
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Synergy Health Concepts, Inc.:
CCSVI, Flow, Perfusion in MS