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).

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05380362

Recruitment Status:

Completed

Sponsor:

University at Buffalo

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Gates Circle Hospital
Buffalo New York, 14209, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05380362

Recruitment Status:

Completed

Sponsor:


University at Buffalo

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider