Multiple Sclerosis Clinical Trial
Prospective Randomized Endovascular Therapy in Multiple Sclerosis
Summary
To assess the safety of endovascular therapy (balloon angioplasty) for venous stenoses in MS patients with CCSVI as documented by sonographic (extracranial echocolor-Doppler (ECD) and transcranial color Doppler (TCD)
To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS).
To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters.
To evaluate change in patients self-reported QOL following the therapeutic angioplasty
To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).
Eligibility Criteria
Inclusion Criteria:
Age 18-65 years
EDSS 0-6.5
Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
Be on treatment with currently FDA approved disease-modifying treatments
Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
Demonstration of venous occlusive disease on cervical MRV
Normal renal function: creatinine clearance level of >60:
Constant= 1.23 for men; 1.04 for women
Exclusion Criteria:
• Relapse, disease progression and steroid treatment in the 30 days preceding study entry
Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.)
Severe peripheral chronic venous insufficiency
Abnormal renal function
Contrast allergy (anaphylaxis)
Not accepting to undergo the endovascular treatment
Peripheral Vascular Disease
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There is 1 Location for this study
Buffalo New York, 14209, United States
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