Multiple Sclerosis Clinical Trial

Natalizumab and Chronic Inflammation

Summary

In this study the investigators will assess the ability of Natalizumab, a medication given to treat multiple sclerosis (MS), to restore blood brain barrier integrity and repair subtle leakages of the blood brain barrier (BBB).

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Full Description

The investigators will image a cohort of persons with relapsing remitting multiple sclerosis (pwRRMS) using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and selective inversion recovery quantitative magnetization transfer imaging (SIR-qMT). pwRRMS will be imaged at baseline and at month-3 and month-12, after starting treatment with natalizumab. Changes in ktrans, a measure of BBB permeability derived from DCE-MRI, and in pool saturation ratio (PSR) a measure of myelin integrity derived from SIR-qMT will be computed to assess the ability of natalizumab to fully restore BBB integrity.

As a corollary aim, the investigators will assess changes in quality of life (QoL) measurements and the relation between those measurements and those derived from the above detailed quantitative MRI methods. QoL will be measured using the Visual Analogue Scale. This questionnaire entails 13 questions regarding the perceived effect of Tysabri, but also level of pain, fatigue, anxiety, depression before and during treatment with natalizumab. The answer to each question is rated on a color-coded bar the range of which is between 0 to 100.

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Eligibility Criteria

Inclusion Criteria:

multiple sclerosis
clinical eligibility to treatment with Natalizumab
no previous exposure to Natalizumab treatment

Exclusion Criteria:

inability to perform an MRI with contrast
inability to undergo a paper-pencil questionnaires and blood work

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

1

Study ID:

NCT05177718

Recruitment Status:

Terminated

Sponsor:

Vanderbilt University Medical Center

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There is 1 Location for this study

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Vanderbilt University Medical Center
Nashville Tennessee, 37215, United States

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Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

1

Study ID:

NCT05177718

Recruitment Status:

Terminated

Sponsor:


Vanderbilt University Medical Center

How clear is this clinincal trial information?

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