| Contents |
| CCSVI studies involving interventional treatment - updated 11 Dec 2010 |
| CCSVI studies with no interventional treatment included - updated 02 Sep 2011 |
| Abstracts of papers currently pre-publication (or not yet free to public view) - updated 02 Sep 2011 |
CCSVI studies involving interventional treatment |
__________________________________________________________________________________________________
|
USA |
|
Study: |
Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis (interventional study)
|
Current Status: |
Currently recruiting participants. United States: Institutional Review Board (IRB) approved Updated 20 September 2010 |
Sponsored by: |
Community Care Physicians, P.C. |
Centre: |
The Vascular Group, PLLC, The Vascular Pavillion, Albany, New York, United States, 12205 Albany NY, USA |
Conducted by:
Gary Siskin, MD, Professor and Chairman Department of Radiology (primary investigator),
Description:
The study is being done to determine if venous angioplasty is an effective treatment for chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or blockages are present in the internal jugular or azygos veins (veins which drain blood from the central nervous system) and these blockages may be associated with symptoms classically attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two groups of patients: one group with CCSVI diagnosed on a venogram and treated with angioplasty and one group with CCSVI diagnosed on a venogram but not treated. The patients enrolled in this study, and the neurologist evaluating patients after the procedure, will not know whether or not they were treated with angioplasty.
* Impact of CCSVI treatment on quality of life in patients with MS [ Time Frames: 1 Month, 3 Months, 6 Months, 12 Months, 18 months, 24 months ] [ Designated as safety issue: No ]
This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.
* 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:
* Clinical significance of CCSVI in MS patients [ Time Frames: 1 month, 6 months, 12 months, 18 months, 24 months ]
[ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, Expanded Disability Status Scale (EDSS) change and change in the timed 25 foot walk.
* Superiority of angioplasty to observation for treatment of CCSVI [ Time Frames: 1 month, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk
* Incidence of CCSVI in patients with MS [ Time Frame: 0 Months ] [ Designated as safety issue: No ]
This will be assessed on the basis of the findings on diagnostic venography of the internal jugular and azygos veins, which is the initial procedure performed in these patients.
* Safety of endovascular treatment of CCSVI [ Time Frames: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: Yes ]
This is defined as the number and nature of any procedure-related adverse effects
* Target vessel primary and secondary patency [ Time Frames: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion
* 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: 130
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
| Arms | Assigned Interventions |
| Treatment of CCSVI with Angioplasty: Experimental At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will be treated with angioplasty. |
Procedure: Angioplasty In this procedure, a small catheter (tube) that is approximately the size of a piece of spaghetti is introduced into the vein that is narrowed based on the findings of the venogram. This catheter has a small balloon on it. That balloon is inflated across the narrowing within the vein with the goal of increasing the diameter of that vein and improving flow within that vein. |
|
|
|
| Observation of CCSVI: Sham Comparator At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will not be treated with angioplasty. These patients will be observed after treatment and compared to those patients who received treatment. |
Other: Observation Patients in this arm will be diagnosed with CCSVI based on venography but will receive no intervention. They will be followed in the same manner as patients treated with angioplasty. |
Reports:
Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis
V-Aware, Vol 2 Issue 3, CCSVI and Multiple Sclerosis, 2010 November
__________________________________________________________________________________________________
|
USA |
|
Study: |
Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients (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 Updated 31 August 2010 |
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.
* 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:
Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients
V-Aware, Vol 2 Issue 3, CCSVI and Multiple Sclerosis, 2010 November
________________________________________________________________________________________________
|
USA |
|
Study: |
PREMiSe (Prospective Randomized Endovascular therapy in Multiple Sclerosis) (interventional study) |
Current Status: |
Ongoing - Phase I of the study began on June 29 and 30, 2010 |
Centre: |
The University at Buffalo, Department of Neurosurgery, Buffalo, New York State, USA |
Conducted by:
Adnan Siddiqui, MD, assistant professor of Neurosurgery, UB School of Medicine and Biomedical Sciences (principal investigator)
Elad Levy, MD, associate professor UB Department of Neurosurgery (co-principal investigator)
L.N. Hopkins, MD,professor and chair, UB Department of Neurosurgery (co-principal investigator)
In collaboration with:
Additional independent researchers from University at Buffalo to participate in the evaluation and follow-up of study patients.
Study Numbers:
Phase 1, ten MS patients from the USA and Canada to undergo venous angioplasties to determine safety
Phase II, 20 MS patients randomised to undergo either venous angioplasty or a sham angioplasty
Description:
The objective is to determine if endovascular intervention via balloon angioplasty to correct the blockages improves MS symptoms or progression. PREMiSe is believed to be the first IRB-approved prospective randomized double-blinded study of balloon angioplasty for MS being performed in a rigorous fashion in the US with significant safeguards in place to ensure careful determination of risks and benefits. An independent Data Safety Monitoring Board (DSMB) will ensure the safety and effectiveness of the study on an ongoing basis. In the first phase of the study, ten MS patients from the United States and Canada exhibiting venous insufficiency will undergo minimally invasive venous angioplasties to determine if the procedure can be performed safely. The procedures, scheduled for June 29 and 30, 2010, will be performed by Drs. Siddiqui and Levy at Kaleida Healths Millard Fillmore Gates Hospital in Buffalo, New York. The second phase of the study will randomize 20 MS patients to undergo either venous angioplasty or a sham angioplasty (i.e. a catheter will be inserted but there will be no inflation of the balloon). The treatment will be blinded in such a way that neither the patient undergoing the procedure nor the clinicians evaluating the patient will be aware which procedure was performed. If results suggest an appropriate safety profile and preliminary effectiveness, then researchers will approach the University at Buffalo Institutional Review Board (IRB) for an extension of the protocol to study a larger number of patients in order to convincingly prove or disprove a causal relationship between CCSVI and MS.
Reports:
Interview with Dr Siddiqui and Dr Levy: July 16 2010 WKBW 7am Buffalo News Programme, Part 1
Interview with Dr Siddiqui and Dr Levy: July 16 2010 WKBW 7am Buffalo News Programme, Part 2
UB launches clinical trial of new MS treatment July 05 2010, UB Reporter
University at Buffalo Launches Clinical Trial Of New Multiple Sclerosis Treatment: June 30 2010, UB Press Release
__________________________________________________________________________________________________
|
KUWAIT |
|
Study: |
Kuwait CCSVI Study (interventional study) |
Current Status: |
Ongoing - Study began on May 4th 2010 |
Centre: |
Mubarak Al-Kabeir Hospital, Kuwait |
Conducted by:
Dr. Tariq Sinan (primary investigator), Consultant Interventional Radiologist
Dr. Hussein Safar, Consultant Vascular Surgeon
Dr. AbdulAziz Almuzaini, Vascular Imaging Consultant
Dr. Sulaiman Al Khashan, Consultant Neurologist
Study Numbers:
62 MS patients have been enrolled (envisaged numbers 100-500)
Description:
The objective is to diagnose MS patients with Chronic cerebrospinal venous insufficiency (CCSVI) and to evaluate them with Duplex scanning and magnetic resonance venography, to evaluate clinical and or radiological improvement of these cases after treating them with angioplasty (with or without stent) of the diseased affected part of the internal jugular vein.
Reports:
Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis patients - Kuwait: May 04 2010
Download Study Introduction as PDF: Kuwait CCSVI Study Introduction
__________________________________________________________________________________________________
|
ITALY |
|
Study: |
CCSVI Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis: A Longitudinal, Magnetic Resonance Imaging, Blinded Pilot Study
|
Current Status: |
Pre-publication |
Centre: |
University of Ferrara, Ferrara, Italy; NY State University in Buffalo, Buffalo, NY, USA |
Conducted by:
Zamboni P (primary investigator), Galeotti R, Weinstock-Guttman B, Cutter G, Menegatti E, Malagoni AM, Bartolomei I, Cox JL, Salvi F, and Zivadinov R:.
Study Numbers:
16 persons
Reports:
Download Study Abstract as PDF: Abstract - Ferrara/Buffalo
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:
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
__________________________________________________________________________________________________
|
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
__________________________________________________________________________________________________
|
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
__________________________________________________________________________________________________
|
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
__________________________________________________________________________________________________
|
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. |
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.
__________________________________________________________________________________________________
|
USA |
|
Study: |
The fMRI BOLD Response in MS, Support for the CCSVI Hypothesis
|
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
__________________________________________________________________________________________________
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.
__________________________________________________________________________________________________
|
USA |
Updated! 14 Jul 2011 |
Study: |
Study of CCSVI in MS using quantitative time-resolved 3D MRV
|
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
__________________________________________________________________________________________________
|
USA |
Updated! 14 Jul 2011 |
Study: |
CCSVI and its relationship to MS
|
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
__________________________________________________________________________________________________
|
USA |
Updated! 14 Jul 2011 |
Study: |
A Multi-Modal Assessment of Chronic Cerebrospinal Venous Insufficiency
|
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
__________________________________________________________________________________________________
|
CANADA |
Updated! 14 Jul 2011 |
Study: |
Investigation into Venous Insufficiency in Multiple Sclerosis
|
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
__________________________________________________________________________________________________
|
CANADA |
Updated! 14 Jul 2011 |
Study: |
Determining the relationship between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS)
|
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
__________________________________________________________________________________________________
|
CANADA |
Updated! 14 Jul 2011 |
Study: |
Cerebral Venous Hemodynamics in Pediatric Multiple Sclerosis
|
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
__________________________________________________________________________________________________
|
CANADA |
Updated! 14 Jul 2011 |
Study: |
Chronic Cerebrospinal Venous Insufficiency in relation to Multiple Sclerosis
|
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:
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:
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
Scientific papers currently pre-publication
|
| (links to abstracts of papers in pre-publication stage, or not yet free to public view) |
New!
European Journal of Vascular and Endovascular Therapy, published online, 12 August 2011
Zamboni P, Galeotti R, Weinstock-Guttman B, Kennedy C, Salvi F, Zivadinov R
| View abstract as HTML: |
Venous Angioplasty in Patients with Multiple Sclerosis: Results of a Pilot Study |
__________________________________________________________________________________________________
New!
Journal of Endovascular Therapy, Volume 18, Issue 3 (June 2011)
Petrov I, Grozdinski L, Kaninski G, Iliev N, Iloska M, and Radev
| View abstract as HTML: | Safety Profile of Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis |
__________________________________________________________________________________________________
J Neurol Neurosurg Psychiatry. 2010 Oct
van Rensburg SJ, and van Toorn R
| Paper critical of theory of link between CCSVI and MS |
| View abstract as HTML: | No association of abnormal cranial venous drainage with multiple sclerosis: a magnetic resonance venography and flow-quantification study |
__________________________________________________________________________________________________
Neurology. 2010 Sepvan Rensburg SJ, and van Toorn R
| View abstract as HTML: | The controversy of CCSVI and iron in multiple sclerosis: Is ferritin the key? |
__________________________________________________________________________________________________
Pathophysiology. 2010 JulJ. Steven Alexander, Robert Zivadinov, Amir-Hadi Maghzi, Vijay C. Ganta, Meghan K. Harris and Alireza Minagar
| View abstract as HTML: |
Multiple sclerosis and cerebral endothelial dysfunction: Mechanisms |
__________________________________________________________________________________________________
J Neurosci Res 2010 Feb.
Simka M, and Zaniewski M
View in PubMed:
__________________________________________________________________________________________________
J Neurol Sci 2010 JanQiu W, Raven S, Wu JS, Carroll WM, Mastaglia FL, and Kermode AG
View abstract as HTML: Wedge-shaped medullary lesions in multiple sclerosis
View in PubMed:
__________________________________________________________________________________________________
Neurology 2009 Sep;73(13):1006-7Pirko I, and Zivadinov R
View abstract in PubMed: Transcranial sonography of deep gray nuclei: a new outcome measure in multiple sclerosis?
__________________________________________________________________________________________________
Int Angiol 2009 Dec;28(6):434-51. Montecarlo September 4th 2009Lee BB, Bergan J, Gloviczki P, Laredo J, Loose DA, Mattassi R, Parsi K, Villavicencio JL, and Zamboni P
| View abstract as HTML: | Diagnosis and treatment of venous malformations Consensus Document of the International Union of Phlebology (IUP)-2009 |
A Consensus Conference on Venous Malformations – headed by Prof. Byung B Lee from Georgetown – and experts from 47 countries – studied the evidence and voted unanimously in favour of officially including the stenosing lesions found in CCSVI in the new Consensus document and Guidelines.
CCSVI is now classified among venous malformations.