Prospective Randomized Endovascular Therapy in Multiple Sclerosis

University at Buffalo30 enrolled

Overview

1. 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) 2. To study the morphology of the venous anomalies by using intraluminal ultrasound (IVUS). 3. To evaluate preliminary efficacy of endovascular therapy (angioplasty) as measured by clinical (relapse rate, disability progression (EDSS)), sonographic (ECD/TCD) and MRI/MRV parameters. 4. To evaluate change in patients self-reported QOL following the therapeutic angioplasty 5. To evaluate whether changes in QOL, fatigue, MSFC or attention following therapeutic angioplasty are associated with brain changes as measured by functional MRI (fMRI).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Patients With Immediate and Short-term SAE

Percent (%) of patients with Severe Adverse Events (SAE) measured at 1 month (Short term) post-surgical safety outcome in MS patients diagnosed with CCSVI that underwent therapeutic angioplasty. The 95% confidence interval of the SAE rates for immediate and short terms will be obtained by the exact method, respectively. The immediate and short term SAE rates will be analyzed, respectively, using the Fisher's exact test.

Time frame: 1 month post-procedure