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CCSVI studies with no interventional treatment included

 

CANADA

 New! Sept 2011

Study:

TAMSI - The Alberta Multiple Sclerosis Initiative (non-interventional study)

Current Status:

The MS community in Alberta who have undergone CCSVI therapy overseas are invited to register.

Funded by:

Alberta Health and Wellness (AHW), a government ministry that sets policy and direction to lead, achieve and sustain a responsive, integrated and accountable health system.

Centre:

University of Calgary, Alberta, Canada

Conducted by:
The TAMSI research study is being led by researchers from the University of Calgary in collaboration with researchers and clinicians from the University of Alberta, Alberta Health Services, and the University of Manitoba . The Principal Investigator is Dr Luanne Metz

Study Numbers:
Dependant on numbers who volunteer

Qualifications
To participate you must be at least 18 years of age, be a resident of Alberta , and have an Alberta personal health number (PHN). You must also meet one of the two following criteria:

1) You must have MS or a related condition such as neuromyelitis optica (Devic's disease), optic neuritis, transverse myelitis, or a clinically isolated syndrome (CIS). You do not need to have had treatment for CCSVI if you have one of these conditions.
Or
2) If you do not have MS or a related condition you must have had treatment for CCSVI.

Description:
The main purpose of TAMSI is to gather evidence to improve the understanding of CCSVI treatment. It aims to determine the safety of the various treatments being used and describe the range of experiences and outcomes of these treatments. This information is critical in helping to determine appropriate care after CCSVI treatments. It is also necessary to guide the design of clinical trials of CCSVI treatments and to interpret the clinical trial results.

TAMSI will also obtain information from people with MS and related conditions who have not had CCSVI treatment and from people without MS who have had CCSVI treatment. Various treatments for CCSVI will be compared. This project, in combination with other ongoing research, may in the future lead to a provincially organized randomized controlled intervention trial of CCSVI therapy.

This study will also have other benefits that are unrelated to CCSVI making it extremely helpful if all people with MS participate. It will provide information about the health status and living situation of all Albertans with MS and will allow comparison of information provided by people with MS with information from health records and information that can be obtained from provincial health registries, otherwise known as administrative databases. (Administrative databases store coded information about medical services provided to you. For example, if you see a physician, the date and location of the visit, the diagnosis assigned by the physician, and the physician you saw would be recorded. Also, if you had a telephone visit with a multiple sclerosis clinic nurse, similar information would be collected.)

Data obtained in this study will, for example, allow a description of the Alberta MS population by descriptors such as age, geographical location, disability group, and the rate of other medical conditions. This will be useful in planning health services. By comparing data from different sources we will be able to get a more complete picture and determine how well health registry data can be used to detect outcomes following the introduction of new treatments in MS.

This study will also help more Albertans become involved in the research process. You will be asked to indicate if we can contact you by email about other research studies that have already been approved by an Alberta health research ethics board. We also hope this study will be the start of a long-term study of MS in Alberta. However, the data that you provide will not be used for any other study, including an extension of this study, without your consent. You are not being asked for your consent at this time for any future studies.

By participating participants will be agreeing to:
· Answer self-report questionnaires through a secure website at baseline and again in 6, 12, 18, and 24 months.
· Allow research assistants to contact you to obtain information about adverse events that you experienced (if any) and, if necessary, clarify information that you provided in the questionnaires.
· Allow the investigators to obtain your medical records to further characterize your CCSVI treatment or adverse events that you experience, (if any).
· Allow the investigators to match your questionnaire data to administrative data from Alberta Health and Wellness, Alberta Health Services, and Alberta Vital Statistics.
· Allow the investigators to match your information to data from electronic health records and databases at the Calgary , Red Deer or Edmonton MS clinics (if you have been a patient there).

Reports:
Project Information: TAMSI Survey

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CANADA

 Updated 18 Dec 2010

Study:

CCSVI Blood Flow Study (non-interventional study)

Current Status:

Application now closed, selection currently taking place.

Funded by:

Not funded by any commercial interests. Study doctors have not received any funds for their involvement.
MRI technology is being provided by the Centre.

Centre:

False Creek Healthcare Centre, Vancouver, Canada

Conducted by:
Dr. G. Keith Chambers,
with sub-investigators Dr. Mark Godley and Dr. Tim Meakin
The study doctors are all affiliated with the False Creek Healthcare Centre.

Study Numbers:
200 people, 100 individuals with Multiple Sclerosis and 100 patients who do not have Multiple Sclerosis

Qualifications

  • Participant is 19 years or older
  • Participant has MS for less than 10 years OR be a match in age or gender to someone with MS
  • Participant without Multiple Sclerosis, has no close relatives with Multiple Sclerosis
  • Participant has normal kidney function

Obligations

  • MRI exam of the vessels in the brain
  • Blood test to test kidney function
  • A total time commitment of about 3 hours

Description:

The study is to compare blood vessel differences in people with Multiple Sclerosis compared to individuals without Multiple Sclerosis.
Recently it has been suggested that the blood vessels that return blood from the brain to the heart (veins) are abnormal in individuals with Multiple Sclerosis. While it has been demonstrated that there may be flow disruption in those with Multiple Sclerosis, it needs to be quantified and compared to a population who do not have Multiple Sclerosis.

Reports:
False Creek Healthcare Centre

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CANADA


Study:

CCSVI MS Research Study (non-interventional study)

Current Status:

Pending (awaiting funding)

Centre:

St Joseph's Healthcare, Hamilton, Canada
In Collaboration with:
Hamilton Health Sciences and McMaster University

Study Numbers:
100 MS patients and an equal number of age and gender matched normal healthy subjects. Patients have already been enrolled
Description:

The CCSVI MS Research Study has three main objects: to evaluate the prevalence of cerebrospinal venous abnormalities in patients with MS and compare them to those of the healthy patients not suffering from MS; to demonstrate and quantify the iron deposits of both groups and seek a correlation to their clinical states and to validate MRI and ultrasound tests for reliability, reproducibility and objectivity in the assessment of cerebrospinal abnormalities. The study will take two years to complete.

Reports:
The Digital Journal:   Feb 09 2010

Download Researchers' Statement as  PDF:     MS CCSVI Study Info on Website 31 March 2010
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USA


Study:

Combined Transcranial and Extracranial Venous Doppler (CTEVD) Evaluation in MS and related Diseases study (non-interventional study)

Current Status:

Pending

Funding:

BNAC has until January 1 to reach a fundraising goal of $150,000, which will be matched dollar for dollar by a grant from the Direct-MS Foundation.

Centre:

Buffalo Neuroimaging Analysis Center, Buffalo, New York State, USA
In Collaboration with:
Jacobs Neurological Institute (JNI), University of Buffalo,

Conducted by:
Dr. Robert Zivadinov, MD, PhD (primary investigator),
Dr. Bianca Weinstock-Guttman
Study Numbers:
500 MS patients
Description:
Chronic cerebrospinal venous insufficiency (CCSVI) is an ongoing problem when blood from the brain has difficulty flowing properly to the heart due to blockages or stenoses (narrowing of the veins). The main goal of the CTEVD study is to investigate the prevalence (frequency) of CCSVI in patients with multiple sclerosis (MS) when compared to healthy controls (HC) and controls with other neurological disorders (OND) in a fully blinded manner. Another important aim of the CTEVD study is to investigate the relationship between CCSVI and clinical, magnetic resonance imaging (MRI) and environmental-genetic outcomes in MS patients, HC, and controls with OND.
No Doppler or MRV reports will be given to participants or their physicians. Research MRI reports of the brain can be made available upon request.

Reports:

Download PDF:     BNAC CCSVI Newsletter, Volume 1, Issue 1
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ITALY

 Updated 30 Dec 2010

Study:

Epidemiological study to confirm and extend Dr. Zamboni's findings by evaluating the prevalence of CCSVI in healthy controls, MS and other neurodegenerative diseases (non-interventional study)

Current Status:

Training completed for 15 doctors.
Patient recruitment began October 2010, completed December 2010
Patient scanning began 30 Dec 2010

Funded by:

Italian MS Society (FISM) €900,000

Centre:

40 centres throughout Italy

Conducted by:
Professor Gianluigi Mancardi, Department of Neuroscience, Ophthalmology and Genetics - University of Genoa, principal investigator
Professor Giancarlo Comi, Department of Neurology and Institute of Experimental Neurology (INSPE) - University Vita-Salute San Raffaele Hospital
Dr. Massimo Del Sette of La Spezia
Dr. John Malferrari Reggio Emilia
Professor Erwin Stolz of Giessen, Germany
 

Study Numbers:

2000 patients, 1200 with MS, 400 people with other neurological diseases and 400 healthy controls

Description:

A randomised double blinded study of the venous flow of the patient groups.
"We want to give a definitive certainty to people with MS about possible relationships between CCSVI and multiple sclerosis. The study AISM - IMF has many strengths that guarantee the certainty of outcome. First the numbers: Today we started the path to analyze 2000 patients, 1200 with MS, 400 people with other neurological diseases and 400 healthy controls. All studies performed so far in this area have much lower numbers. In addition, this is a multicenter study: there is one center that does the exam, but there are 40 clinical centers throughout Italy enrolled in MS in the study. And finally, the last point of strength, this study makes it possible to obtain important information on the intracerebral venous flow flowing from the skull, information not previously collected on a population so large."
It is planned to complete the study by the end of 2011.

Reports:

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USA

Study:

The fMRI BOLD Response in MS, Support for the CCSVI Hypothesis
(non-interventional study)

Current Status:

Pending, awaiting funding

Centre:

Hubbard Foundation for fMRI Research, San Diego, CA, USA

Conducted by:
David R Hubbard MD, Medical Director Hubbard Foundation, (Neurologist), Giedrius Buracas, PhD, Associate Research Scientist (Neurosciences), Youngkyoo Jung, PhD (Electrical Engineering),
Study Numbers:
100 patients with early stage relapsing MS and 100 matched normal controls.
Description:
BOLD fMRI have capabilities that allow the examination of the regional abnormalities of the hemodynamic response of BOLD which is a function of venous volume and hence can be affected by venous outflow. We hypothesize that larger venous blood volume due to reflux may modulate the hemodynamic response evoked by neuronal activity. Specifically, the balloon model of the hemodynamic BOLD response (Buxton) predicts that the modulation of the post stimulus undershoot is affected by venous outflow from the cerebral parenchyma (i.e. capillary bed in gray matter). Successful investigation using BOLD fMRI requires specialized capability but addresses the essential question: is delayed drainage from neuron clusters characteristic of MS? We propose to validate the suitability of fMRI BOLD techniques for assessment of the delayed venous outflow in MS. This aim will be achieved by combining the traditional MRA and MRV imaging with fMRI techniques.

Download Grant Proposal as PDF:     Grant Proposal - Hubbard Foundation for fMRI Research

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On 11th June 2010 the National Multiple Sclerosis Society (USA) and the Canadian Multiple Sclerosis Society announced funding for studies in their annual funding round.
Under pressure from persons with MS eager to receive CCSVI treatment, the MS Society of Canada said it is committing $700,000 to study the link between CCSVI and MS. South of the border, the National MS Society said it will spend $1.7 million for the same purpose.

Together, the two organizations will fund seven research projects on CCSVI. The societies chose not to fund any studies which involved actual interventions. The work of the researchers in these initial studies will not involve surgical treatment, but rather the investigation and determination of CCSVI's prevalence in different circumstances. The seven projects are presented, below, in the order of the size of grants awarded.

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USA

Updated! 14 Jul 2011

Study:

Study of CCSVI in MS using quantitative time-resolved 3D MRV
(non-interventional study)

Current Status:

Study running from 1st July 2010 to 30th June 2012

Funded by:

USA National MS Society (NMSS) $593,261

Centre:

University of Wisconsin School of Medicine and Public Health,
Madison, Wisconsin, USA

Conducted by:
Aaron Field MD, PhD, Associate Professor with Tenure in the Department of Radiology at UW-Madison
In association with:
Director of the University MS clinic;
Experts in MRI physics and ultrasound;
Neuroradiologist with extensive experience in vascular imaging;
Statistician with ample experience in clinical research.
Study Numbers:

112 people with early and later MS, 56 controls without MS, and 56 people with other neurological conditions.
Description:

Dr. Field's team is using alternative imaging methods, in addition to the ultrasound method used in Dr. Zamboni's original reports, to conduct a controlled study of the CCSVI hypothesis in people with MS. This study uses an MRI scanner to generate highly detailed images of the head and neck veins . The team is also measuring the rate at which blood flows in the veins. Dr. Field's collaborates have years of experience in bioengineering, radiology, and medical physics.
If this technique obtains similar results as the ultrasound method originally used, it would represent a powerful confirmation of the CCSVI hypothesis and help lead the way toward trials of appropriate treatment targeting abnormal veins.

Reports:
14 July 2011:
Research Teams Report First Year's Progress From MS Societies' Initial Studies on CCSVI and MS
31 December 2010: First six months progress report
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USA

Updated! 14 Jul 2011

Study:

CCSVI and its relationship to MS
(non-interventional study)

Current Status:

Study running from 1st July 2010 to 30th June 2012

Funded by:

USA National MS Society (NMSS) $574,958

Centre:

University of Texas Health Science Center at Houston,
Houston, Texas, USA

Conducted by:
Jerry S. Wolinsky, MD
In association with:
Director of the University's cerebral vascular disease program;
University Chair of diagnostic and interventional imaging;
University Director of MR research;
Director of the MS clinic;
Head of cardiovascular MRI
Study Numbers:

100  persons with all major clinical types of MS, compared with 175 people in various non-MS control groups
Description:Using a comprehensive approach, this team will first attempt to replicate the ultrasound methods used by Dr. Zamboni to investigate the association of CCSVI with major clinical types of MS and in non-MS control groups. Then, they are seeking to determine whether the findings are validated by noninvasive imaging techniques, such as an MRI machine using a powerful magnet to confirm the ultrasound findings, while identifying the most reliable technique to screen for CCSVI.
The team includes experts in MS, as well as experts from other fields such as vascular disease and venous imaging.
"Validating a reliable diagnostic approach and demonstrating that CCSVI is specific to MS and contributes to disease activity would be necessary first steps before controlled therapeutic trials may be attempted."

Reports:
14 July 2011: Research Teams Report First Year's Progress From MS Societies' Initial Studies on CCSVI and MS
31 December 2010: First six months progress report
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USA

Updated! 14 Jul 2011

Study:

A Multi-Modal Assessment of Chronic Cerebrospinal Venous Insufficiency
(non-interventional study)

Current Status:

Study running from 1st July 2010 to 30th June 2012

Funded by:

USA National MS Society (NMSS) $571,261

Centre:

Cleveland Clinic Foundation
Cleveland, Ohio, USA

Conducted by:
Robert J. Fox, M.D., Medical Director of the Mellen Center for Multiple Sclerosis Treatment and Research at Cleveland Clinic
In association with:
Medical Director of the Cleveland Clinic's neurovascular laboratory;
Cardiologist expert in venous ultrasound;
Section Head of imaging sciences;
Others with expertise in neuropathology, anatomy, biomedical engineering, and biostatistics
Study Numbers:

90 people with different forms of MS and 80 controls without MS
Description:
Dr. Fox and his team are seeking to reproduce Dr Zamboni's findings in 90 people with different forms of MS and 80 controls without MS. His team is conducting the same tests that were done in the original studies (ultrasound tests of the veins in the neck), an MRI test that looks specifically at veins, and neurological examinations. Most of these MS patients have been followed for the past 10 years in a longitudinal study using quantitative clinical and imaging measures, which will provide an opportunity to compare CCSVI findings to MS disease evolution. To distinguish whether vein abnormalities are from atrophy (brain tissue volume loss) and not specifically MS, they also are comparing the MS group to people with atrophy from Alzheimer's disease. Finally, they are examining the neck and spinal cord veins obtained via autopsy from people with MS and non-MS controls.
Data from these studies will shed light on the meaning of Dr. Zamboni's original reports and how CCSVI relates to disease activity in MS.

Reports:
14 July 2011: Research Teams Report First Year's Progress From MS Societies' Initial Studies on CCSVI and MS
31 December 2010: First six months progress report
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CANADA

Updated! 14 Jul 2011

Study:

Investigation into Venous Insufficiency in Multiple Sclerosis
(non-interventional study)

Current Status:

Study running from 1st July 2010 to 30th June 2012

Funded by:

MS Society of Canada C$200,000 over 2 years

Centre:

University of British Columbia Hospital MS Clinic, UBC Faculty of Medicine and
Saskatoon MS Clinic, University of Saskatchewan

Conducted by:
Anthony Traboulsee, MD
Medical Director, MS Clinic at UBC Hospital, Vancouver Coastal Health and University of BC
Vancouver, BC, Director of the MS Clinical Trials Research Group, and Assistant Director of the MS/MRI Research Group. He is also Assistant Professor of Medicine/Neurology at UBC Faculty of Medicine

Katherine Knox, MD
Saskatoon MS Clinic, University of Saskatchewan
Saskatoon, Saskatchewan
Director of the Saskatoon MS Clinic and Assistant Professor with the College of Medicine, University of Saskatchewan
In association with:
• Dr. David K.B. Li, UBC Hospital, VCH/UBC
• Dr. Lindsay Machan, UBC Hospital, VCH/UBC
• Dr. Alexander Rauscher, MRI Research Centre, VCH/UBC
• Dr. Alex MacKay, MRI Research Centre, VCH
• Prof. Judy Illes, Brain Research Centre, VCH/UBC
• Dr. Christopher Voll, Faculty of Medicine, University of Saskatchewan
• Dr. Sheldon Wiebe, Department of Medical Imaging, University of Saskatchewan
• Dr. Peter Szkup, Royal University Hospital, University of Saskatchewan
• Dr. Michael Kelly, Royal University Hospital, University of Saskatchewan

Study Numbers:

A total of 200 participants including eligible persons with MS and their family members who are registered with the Canadian Collaborative Project on Genetic Susceptibility to MS (CCPGSMS). Recruitment number is approximate and is subject to change.
Description:
• The team is studying the prevalence of CCSVI in 200 people including those with MS and controls without MS, using catheter venography, ultrasound, and magnetic resonance venography.
• Unique to this study is the inclusion of family members, such as identical twins of MS patients who have not developed MS, in control groups.
• The team hopes to verify the usefulness of non-invasive techniques that would make it easier to screen for CCSVI, which would be needed if results from this and other research confirm that future therapeutic trials are warranted.
• The research aims to determine the reliability and accuracy of different imaging techniques for screening for CCSVI. This information will be needed if results from this and other research confirms that future therapeutic trials are warranted.

Reports:
14 July 2011: Research Teams Report First Year's Progress From MS Societies' Initial Studies on CCSVI and MS
31 December 2010: First six months progress report
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CANADA

Updated! 14 Jul 2011

Study:

Determining the relationship between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS)
(non-interventional study)

Current Status:

Study running from 1st July 2010 to 30th June 2012

Funded by:

MS Society of Canada C$199,994.18 over 2 years

Centre:

Hotchkiss Brain Institute, Faculty of Medicine, University of Calgary
Calgary, Alberta

Conducted by:
Fiona Evanne Costello, MD, FRCP, Hotchkiss Brain Institute, University of Calgary

Dr. Michael Hill, Associate Dean of Clinical Research and a member of the Hotchkiss Brain Institute at the University of Calgary who has expertise in clinical epidemiology;

In association with:
Experienced team of collaborators including radiologists specializing in imaging of the blood vessels, interventional radiologists, and magnetic resonance imaging experts.
• Dr. Mayank Goyal, Hotchkiss Brain Institute, University of Calgary
• Dr. Richard Frayne, Hotchkiss Brain Institute, University of Calgary
• Dr. Jean K. Mah, Hotchkiss Brain Institute, University of Calgary
• Dr. Jeptha Davenport, Hotchkiss Brain Institute, University of Calgary
• Dr. James Scott, , University of Calgary

Study Numbers:

A total of 180 participants including adults and children with MS and healthy participants. Participants with MS will be recruited from the Calgary MS Clinic at Foothills Medical Centre. Recruitment number is approximate and is subject to change.
Description:
This controlled study will carefully compare vein drainage between a cross-section of 120 people with MS with that seen in 60 healthy controls. In those MS patients who exhibit signs of abnormalities of vein drainage, the investigators will explore whether the sites and severity of vein abnormalities correlate with common markers of MS disease activity, seeking linkages between any venous abnormalities observed and many different aspects and measures of MS activity and tissue damage.
The team is using ultrasound as originally used by Dr. Zamboni, and magnetic resonance studies of the veins (MR venography) to further explore the prevalence of venous insufficiency. The technologists and radiologists who interpret all scans will be blinded as to the clinical status of the participants.
This study should help quickly determine whether there are significant differences in venous drainage in people with MS, and their implications for the future treatment of MS.

Reports:
14 July 2011: Research Teams Report First Year's Progress From MS Societies' Initial Studies on CCSVI and MS
31 December 2010: First six months progress report
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CANADA

Updated! 14 Jul 2011

Study:

Cerebral Venous Hemodynamics in Pediatric Multiple Sclerosis
(non-interventional study)

Current Status:

Study running from 1st July 2010 to 30th June 2012

Funded by:

MS Society of Canada C$196,579.14 over 2 years

Centre:

The Hospital for Sick Children and University of Toronto, Ontario, Canada

Conducted by:
Brenda Banwell, MD, Director of the Pediatric MS Clinic , Research Chair of the International Pediatric MS Study Group
In collaboration with:
• Dr. Christopher Macgowan, The Hospital for Sick Children and University of Toronto
• Dr. Suzanne Laughlin, The Hospital for Sick Children and University of Toronto
• Dr. Manohar Shroff, The Hospital for Sick Children and University of Toronto
• Dr. John Sled, The Hospital for Sick Children and University of Toronto
• Dr. Rae Yeung, The Hospital for Sick Children and University of Toronto
• Dr. Susanne Benseler, The Hospital for Sick Children and University of Toronto
• Dr. Jeffrey Traubici, The Hospital for Sick Children and University of Toronto
• Dr. Mahendranath Moharir, The Hospital for Sick Children
• Dr. Douglas Arnold, Montreal Neurological Institute, McGill University
• Dr. Sridar Narayanan, Montreal Neurological Institute, McGill University
• Dr. Amit Bar-Or, Montreal Neurological Institute, McGill University
• Dr. Ruth Ann Marrie, MS Clinic director, University of Manitoba

Dr. Banwell has assembled a team that includes – among others – an imaging scientist who is leading a program to evaluate blood flow in children, pediatric neuroradiologists with extensive expertise in cerebrovascular imaging in children, a world-renowned neuroimaging expert in the field of MS, and a pediatric neurologist with experience in venous malfunction in children.

Study Numbers:
A total of 60 participants that includes healthy children and adolescents and pediatric MS participants. Participants with MS will be within 5 years of their first MS attack and recruited from the Pediatric MS Clinic at The Hospital for Sick Children . Recruitment number is approximate and is subject to change.
Description:
The team is to study CCSVI in pediatric MS patients – a population where the disease process is at a very early stage, and where advanced age and other health conditions that might affect blood flow do not exist. They are determining whether CCSVI occurs in children with MS using non-invasive MRI measures of vein anatomy and novel measures of venous flow and are comparing the results to children without MS. The team also is using "hemodynamic" (blood flow) tests to investigate a hypothesis that might explain how blood flow problems could lead to myelin damage, through the accumulation of excess iron.
Determining whether the veins and vein flow are abnormal very early in the MS process in pediatric MS will add additional depth to studies of CCSVI in adult MS.

Reports:
14 July 2011: Research Teams Report First Year's Progress From MS Societies' Initial Studies on CCSVI and MS
31 December 2010: First six months progress report
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CANADA

Updated! 14 Jul 2011

Study:

Chronic Cerebrospinal Venous Insufficiency in relation to Multiple Sclerosis
(non-interventional study)

Current Status:

Study running from 1st July 2010 to 30th June 2012

Funded by:

MS Society of Canada C$102,866 over 2 years

Centre:

The Ottawa Hospital
Ottawa, Ontario, Canada

Conducted by:

Carlos Torres, MD, neuroradiologist at The Ottawa Hospital and an Assistant Professor of Radiology at The University of Ottawa

In collaboration with:
• Dr. Ian G. Cameron, Department of Diagnostic Imaging (MRI Unit)
• Dr. Matthew J. Hogan, Division of Neurology
• Dr. Mark E. Schweitzer, Department of Radiological Sciences and Department of Diagnostic Imaging
• Dr. Cheemun Lum, Department of Diagnostic Imaging
• Dr. Miguel E. Bussière, Division of Neurology
• Dr. Santanu Chakraborty, Department of Diagnostic Imaging• Dr. Santanu Chakraborty, Department of Diagnostic Imaging
• Dr. Mark S. Freedman, Division of Neurology (MS Research Unit)
(all are affiliated with The Ottawa Hospital, the Ottawa Hospital Research Institute and the University of Ottawa)

Study Numbers:

A total of 100 participants including participants with MS and healthy individuals. Participants will be recruited through The Ottawa Hospital MS Clinic Research Unit. Recruitment number is approximate and is subject to change.
Description:

This team is employing "3 Tesla" MRI technology that is twice as powerful as a standard MRI magnet to explore differences in the anatomy of veins in the neck, chest and spine and to assess for iron deposits in the brain. They are comparing findings in 50 people who have MS with those in 50 age-matched healthy volunteers. They are also using Doppler ultrasound techniques that were used by originators of the CCSVI hypothesis, and seeking verification that there is a relationship between blocked veins and areas of iron deposition in the brain by measuring levels of iron in the brain in those with and without vein blockages. The questions the team is focused on include: How frequent are the vein blockages and abnormalities in people who do not have MS? How frequently do they occur in people with MS? Can the team detect brain iron pooling in patients with blocked veins?

These studies should lead to a better understanding of normal variations in the anatomy of the veins that drain the brain, and the potential role of venous insufficiency in MS.
Carlos Torres says "Results of this study will definitively confirm whether venous obstructions are clearly associated with MS or are a normal phenomenon. In addition, it will indicate whether excess iron deposition in the brain correlates with the presence of associated venous obstruction. Only with such results could a treatment trial aimed at relieving obstructions be considered."

Reports:
14 July 2011: Research Teams Report First Year's Progress From MS Societies' Initial Studies on CCSVI and MS
31 December 2010: First six months progress report

back to index of studies in progress 

 

USA

 

Study:

Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients
500 Person (interventional study)

Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study (Liberation Study)

Current Status:

Currently recruiting participants.  United States: Institutional Review Board (IRB) approved

Centre:

The Vascular Group, PLLC, The Vascular Pavillion, Albany, New York, United States, 12205 Albany NY, USA

Conducted by:
Dr. Manish Mehta, MD, MPH   (primary investigator),
Description:
Study to evaluate treating chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis patients.

Primary Outcome Measures:

* Incidence of major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
The evaluation of safety will be defined as the incidence of major adverse events at 30 days following the index procedure. The evaluation of feasibility and efficacy will be determined by those patients that do not have more than 50 percent restenosis within the 30 day time frame.

Secondary Outcome Measures:

* Mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary endpoints will be evaluated with all subjects based upon mortality, incidence of all secondary interventions and incidence of all major adverse events for a period of 2 years.

Estimated Enrollment: 500
Study Start Date: August 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:

* Procedure: Angioplasty
To identify the presence of CCSVI, all patients will undergo a clinical evaluation by a neurologist, a duplex ultrasound of central extracranial venous system, an MRV, and a venogram. The decision to enroll patient in percutaneous angioplasty for CCSVI will be made at the time of venogram, in select patients that have greater than or equal to 50 percent stenosis of the extracranial central veins including the internal jugular veins and the azygos vein. Extracranial venous ultrasound will be performed at 3, 6, 12, 18, and 24 months following the procedure or if clinical symptoms recur. MRV and venograms will be performed at 12months and 24 months or if clinical symptoms recur.

Reports:

View study as HTML:    
Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients

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                                                                 This website does not purport to, nor intend to replace medical advice but to complement it by signposting to other possibilities in the understanding
                                                                                     of the symptoms labelled Multiple Sclerosis.  Individuals should always seek medical advice from their doctor.