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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Synergy Health Concepts, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Synergy Health Concepts, Inc.
ClinicalTrials.gov Identifier:
NCT01593904
First received: May 6, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose
  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
Venous Irregularities, Flow and Perfusion in MS and Non-MS Participants

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Venous Irregularities, Flow and Perfusion in MS Study

Further study details as provided by Synergy Health Concepts, Inc.:

Estimated Enrollment: 400
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Synergy Health Concepts, Inc.
ClinicalTrials.gov Identifier: NCT01593904     History of Changes
Other Study ID Numbers: VERIFYMS
Study First Received: May 6, 2012
Last Updated: May 6, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014