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Alfred Hospital Australia - CCSVI Clinical Trial

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What  is Multiple Sclerosis? News Headlines Brave Dreams CCSVI Clinical Trial CCSVI Research database

Help us achieve our Fundraising  Target of $450,000 - Last revised November 2017
  Achieved $322,000 Still Needed $128,000 - Donate Here
Pre Trial Outcomes - 2010
When referring to pre-trial outcomes Alfred Hospital's Dr Helen Kavnoudias said ''42 people with MS and venous abnormalities were treated (with angioplasty} in a pre-trial at The Alfred in 2010. Patients reported improvements in vision, mobility, balance, fatigue, cognition and heat tolerance amongst other things. Such functional improvements were reported that people were returning to full time work and made decisions to start families. For progressive forms of MS there is currently no treatment. This research has the potential to improve the quality of life of 23,000 Australians'' read about related global developments.
Helen went on to say  ''we hope to provide viable and valuable alternative to pharmaceuticals and provide new opportunities to greatly improve quality-of-life in at least two-thirds of MS patients''
A 2010 study estimated that the cost of MS (in Australia) per person was $48,945 bringing the overall burden of MS to $1.125 billion annually. Subsequent drug approvals on the Pharmaceutical Benefits Scheme increased these costs considerably with new oral medications medications at three times the cost of existing injectable treatments. Given the then scheduled fee on Medicare for this treatment (angioplasty) of approx. $1,300 (compared with approx.$48,000 pa for recently approved MS drugs on the PBS) it could offer potential savings to our public health system, Of interest in 2015 the pharmaceutical Lemtrada was added to the PBS at an estimated minimum cost per person of $70,000 -  more about cost/benefits.
Related Developments
These pre-trial outcomes and and expectations are supported by subsequent research including long term monitoring of treatment  outcomes
The Key Question
In November 2011, Australia’s peak Health Policy Advisory Committee on Technology (HealthPACT) said "the outcomes from randomised, controlled, clinical trials with long-term follow-up of patients will need to be evaluated before this procedure can be widely adopted." In saying this HealthPACT identified the purpose of such trials as being to answer the question "Does Percutaneous Venoplasty make a difference in relieving the symptoms of multiple sclerosis by improving cerebrospinal venous drainage
Responding to this Question
This trial originated in April 2012 at the Alfred Hospital (Melbourne, Australia) under the guidance of Professor Ken Thomson and Dr Helen Kavnoudias (watch a video presentation by Helen) and involves 160 participants. While more than this number are on the waiting list further funding is needed.
Helen describes the trial in the following terms ''this project is highly significant as it will be the first blinded and randomised clinical trial conducted to determine whether there is any benefit in performing PTA in MS patients''. The objectives of this study are to determine whether PTA treatment can restore blood flow through these vessels and whether this can relieve the negative effects suffered by MS patients. About related research.
On 16 August 2012, in a letter to the Parliamentary Friends of People with Multiple Sclerosis, MS Australia described this research as vital and said that it would actively work with the Alfred Hospital to engage funds to complete this research.
Leadership by Australia's Multiple Sclerosis Community
 In April 2013, CCSVI Australia was incorporated as a charitable organisation to provides leadership in the fund raising process. The significance of this patient-centred leadership was subsequently  recognised through Kerri Cassidy (CEO of CCSVI Australia) being selected as the winner of Australia's 2016 National Award for Excellence in  Justice and Rights Protection.
International Recognition
In March 2015 the International Society for Neurovascular Disease (ISNVD) described multiple sclerosis research being undertaken at the Alfred Hospital Melbourne Australia as:  nb:
'one of  the worlds most sophisticated research projects into palliating, treating and curing neurovascular diseases, such as multiple sclerosis - aiming towards meaningful diagnostic and treatment strategies''.
In so saying, and in partnership with the Annette Funicello Research Fund for Neurological Disease (AFRFND), it selected this research as one of four recipients of its 2015 research grants. This increased to nearly $250,000 (currently $320,650) the funds raised to complete this research. $450,000 in total is needed to determine whether angioplasty (a long proven, safe and minimally invasive 1 hour day surgery vascular procedure) can restore vascular blood flow and whether this can relieve the negative effects suffered by people with multiple sclerosis
Trial Updates
A total of 34 trial participants had been screened by May 2014, 27 of whom have been confirmed to have CCSVI. 26 are continuing on to the treatment phase. In other words, in this random sample of 34 people with MS, 4 out of 5 (80%) had identifiable venous abnormalities in either the jugular and/or azygos veins. Dr Helen Kavnoudias and Kerri Cassidy presented preliminary trial results and experiences at the National CCSVI Society of Canada’s annual conference in October 2014. .
April 2016 Update
At the annual meeting of the International Society for Neurovascular Disease ISNVD (April 2016) Dr Kavnoudias reported on ongoing progress including: 
  * All placebo patients received procedure at year one. Patients given Midazolam and had no recollection of procedure--to maintain sham end of the study.
* The trial protocol allowed two procedures per patient,  restenosis were treated as part of that protocol. The procedure is relatively safe. Few mild adverse events. Reflux in 7 patients, 21/28 had valve involvement, 22 had 2-3 stenoses. 3 restenosed within 6 months indicating that balloon angioplasty may not be a solution in itself for everyone - more on this subject.
  * Cognitive test showed significant differences in treatment vs control group. 15% increase in Quality of Life self-test. There was no increase in QOL for patients in placebo group. Improvement in EDSS is trending to significance at p=.08. Needs larger sample size. No placebo effect shown. One person relapsed, was  in the control arm and was on immunomodulators.


May 2017 Update - ISNVD Annual Conference

Regarding comparative findings of multimodal imaging of the internal jugular veins in MS patients, Dr Helen Kavnoudias said:


We were able to quantify limitations of the different imaging modalities to measure abnormalities of the Internal Jugular Vein and confirm that multimodal imaging is required. Agreement between all modalities was only 50%. Agreement between Angiography and Ultrasound was 60%, Angioplasty and MRV was 64% and Ultrasound and MRV was 70%. This confirms that incorporating IVUS would be beneficial.

* Ultrasound imaging for the control arm was obtained before, and in approximately half of patients there were significant differences in the result over the twelve months - high variability within individual patients. Patients were reported as normal at one time point and significantly abnormal (stenosis/flow) at a different time point
  * Some comparative analysis has been completed between the treatment and sham to 24 months. There was no significant difference in two parameters: cerebral arterial flow and between the groups the EDSS was reported and found not to be significant at 12 months. However there was a significant difference in EDSS at 24 months (p=0.016). This EDSS significance gives us momentum to continue with further enrolments..
  * Patients were provided a second treatment for restenosis. There were two relapses recorded over the 24 month period. Studies that don't follow patients for at least 24 months may fail to appreciate improvement over a longer period.
Beyond Australia's first CCSVI Clinical Trial
CCSVI Reference Group In February 2012 the CCSVI Australia Reference Group, reaffirmed its commitment to the key issue, viz "for the Australian Government to put in place policies, programs and practices to support the advancement of CCSVI medical knowledge while, at the same time, addressing the ongoing CCSVI needs of Australians living with MS". Given that much has been learnt globally since the Alfred trial was first envisaged it concluded that an even more focused approach is now warranted - see the proposed Action Strategy. A Quick Reference Guide (following) relating to the top twenty most frequently asked MS Questions and Answers was also developed.
Quick Reference Guide  - 20 Emerging Questions/Answers at a Glance
Information is classified according to issues regularly discussed across MS consumer networks. Questions will change over time as awareness increases. Click on a question to find out more.
* What  is Multiple Sclerosis? - Towards Better Understandings * How Can I be CCSVI tested in Australia?
* Is Fibrinogen build up an MS Trigger? * What about Pregnancy and MS?
* What are the most Common MS Symptoms? * Why is Sunshine exposure important?
* Why are Cardiovascular risk factors in MS of significant concern? * Do Immunotherapy Medications Work?
*  What are the relationships between MS Symptoms & Bloodflow? * What about Stem Cell related Interventions?
* What is the Prevalence of MS Bloodflow Irregularities? * Why is proper Sleep so Important?
* Why is attention to Bloodflow Irregularities so Important? * NDIS & Senior Australians - are the Gaps being closed?
* How are underlying Bloodflow Disorders Identified? * Why is IVUS important ?
* What can be expected from Vascular Interventions? * What about Divergent CCSVI Research Outcomes?
* What is known about Long Term Angioplasty Benefits? * What about Clinical Trials and related Evidence?
For a more detailed overview of ongoing developments check out the latest News Update  

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