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

May 6, 2012 updated by: Synergy Health Concepts, Inc.
  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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92660
        • Recruiting
        • Synergy Health Concepts Inc.
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Joseph Hewett, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synergy Health Concepts, Inc.

Investigators

  • Principal Investigator: John Joseph Hewett, MD, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

May 6, 2012

First Submitted That Met QC Criteria

May 6, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 6, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VERIFYMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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