Venous Irregularities, Flow and Perfusion in MS and Non-MS ParticipantsVERIFYMSNCT01593904
Venous Irregularities, Flow and Perfusion in MS Study
An observational study of Venous Irregularities, Flow and Perfusion in MS and Non-MS Participants, run by Synergy Health Concepts, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Irregularities, Flow and Perfusion in MS and Non-MS Participants
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Human subjects will be approached for participation in this study that are receiving or seeking medical care at Synergy Health Concepts Inc.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Synergy Health Concepts Inc.
Newport Beach, California, 92660
Frances Debarge-Igoe, RN, 949-221-0129, uscangionurse@aol.com
John Joseph Hewett, MD, (949) 221-0129, jhewett@synergyhealthconcepts.com
About this study
- What is the true incidence of CCSVI in patients with MS in a study comparing MRI on MS patients and controls.
- 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
Read the 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.
- Keywords
- CCSVI, Flow, Perfusion in MS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startJan 2012
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Irregularities, Flow and Perfusion in MS and Non-MS ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synergy Health Concepts, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Joseph Hewett, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593904
- Sponsor's protocol ID
- VERIFYMS
- Acronym
- VERIFYMS
- Status last verified
- May 2012
- First submitted
- 6 May 2012
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Irregularities, Flow and Perfusion in MS Study
- ClinicalTrials.gov ID
- NCT01593904
- Acronym / sponsor ID
- VERIFYMS / VERIFYMS
- Keywords
- CCSVI, Flow, Perfusion in MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Synergy Health Concepts, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Study completion
- Jan 2013 (estimated)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- What is the true incidence of CCSVI in patients with MS in a study comparing MRI on MS patients and controls.
- 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Human subjects will be approached for participation in this study that are receiving or seeking medical care at Synergy Health Concepts Inc.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Joseph Hewett, MD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Irregularities, Flow and Perfusion in MS and Non-MS Participants, run by Synergy Health Concepts, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frances Debarge- Igoe, RN ((949) 221-0129, uscangionurse@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2012; AzTrials last refreshed its copy on 30 Oct 2026.