Synergy IRB Research

We encourage you to learn more about our comprehensive CCSVI Research by speaking with our Medical Group or by exploring our two important IRB’s below. We know that finding expert care in pre-procedure imaging and CCSVI treatments is based on ongoing research so providing up to date information on our IRB efforts is critical. In addition to the two current ongoing IRB’s described below, Synergy Health is currently working on two additional IRB studies to begin at the first of 2012.

Synergy Health and our IRB Research Efforts

IRB Protocol: Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment:

Studies indicate that a phenomenon called CCSVI (chronic cerebrospinal venous insufficiency), an abnormality in blood drainage from the brain and spinal cord, may contribute to neurodegenerative disorders. This hypothesis has been put forth by Dr. Paolo Zamboni and is now being pursued by other investigators as well. Dr. Zamboni and others state that this pilot study warrants a subsequent larger and better controlled study to definitively evaluate the possible impact of CCSVI on the disease process in MS. There is other data that suggests the contrary. This amplifies the need for additional studies that can quickly provide answers regarding CCSVI treatment efficacy.
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Many questions remain about how and when CCSVI might play a role in nervous system damage and whether venous angioplasty is helpful in treating the symptoms of CCSVI. Utilizing intravascular ultrasound (IVUS,) this pilot study will provide data that will allow researchers to evaluate venous morphology pre- and post- percutaneous angioplasty and sub-classify valve morphology as related to treatment success by distinguishing vessels which are more responsive to treatment. In addition, this study will validate the safety of valvuloplasty in various neurodegenerative disorders that involve venous obstruction.
 
Thirty (30) subjects who meet eligibility criteria will undergo venography and possible venous angioplasty with possible stent placement. Intravascular Ultrasound (IVUS) will be utilized to acquire images of vessels from inside the vein. IVUS provides detailed and accurate measurements of lumen and vessel size, plaque area and volume, and the location of key anatomical landmarks. The procedure takes approximately one (1) hour with a two to three hours recovery period. In addition, the subject will be requested to have a CCSVI protocol Doppler study forty- eight hours post-procedure. The Doppler study is approximately one (1) to two (2) hours in length.
 
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Our Registry IRB

Subjects will be screened initially using established inclusion and exclusion criteria. Subjects that meet eligibility requirements will be provided with patient education material and an informed consent for review. Once all questions have been answered by the primary investigator or sub-investigators, the subject will voluntarily sign the informed consent.
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A patient questionnaire will be completed pre-procedure. The subject will have a Haacke MRV, a consultation with the physician, venography with possible angioplasty and/or stent placement. The subject will be required to complete the patient questionnaire at 6 and 12 months post-procedure. In addition, the subject will be required to obtain a Zamboni protocol Doppler study at 6 months and a Haacke MRV at 12 months. The risks and benefits of the research registry and procedure are outlined in the informed consent. Steps are taken during the intake process to minimize risks by thoroughly assessing the subjects for co-morbidities that may increase risk. After review of all intake data, the investigator and subject will determine if the subject is an appropriate candidate.
 
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Our Commitment to CCSVI Research

At Synergy Health, we pride ourselves in our commitment to the cause of CCSVI. Synergy Health is currently working on two additional IRB studies to begin at the first of 2012. Unlike solitary practitioners, we work as a group. Because of this, we are better able to expand our understanding of CCSVI through sharing our ongoing experiences and effectively raise the standard of the entire group.

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