Sample-size calculations for short-term proof-of-concept studies of tissue protection and repair in multiple sclerosis lesions via conventional clinical imaging.

ABSTRACT:

Background

New multiple sclerosis (MS) lesion activity on magnetic resonance imaging (MRI) can test immunomodulatory therapies in proof-of-concept trials. Comparably powerful endpoints to assess tissue protection or repair are lacking.

Objective

The objective of this paper is to report sample-size calculations for assessment of new lesion recovery.

Methods

In two sets of six active MS cases, new lesions were observed by monthly MRI for approximately 12 months. Averages and quartiles of normalized (proton density/T1/T2 weighted) and quantitative (T1/T2 and mean diffusivity maps for dataset 1, T2 and magnetization transfer ratio maps for dataset 2) measures were used to compare the lesion area before lesion appearance to afterward. A linear mixed-effects model incorpora

SUBMITTER: Reich DS 

PROVIDER: S-EPMC4527958 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature