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Diffusion tensor imaging in the SPRINT-MS clinical trial: Advancing trial methodology.

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Diffusion tensor imaging (DTI) analysis of the SPRINT-MS trial revealed that radial diffusivity in the cingulum and cerebellar peduncles can detect treatment effects. These DTI metrics show promise for neuroprotective trials in progressive multiple sclerosis.

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Area of Science:

  • Neuroimaging
  • Radiology
  • Neurology

Background:

  • SPRINT-MS was a phase 2 trial investigating ibudilast for progressive multiple sclerosis (MS).
  • Multimodal imaging, including diffusion tensor imaging (DTI), was used to assess brain tissue integrity in the trial.
  • This study refines DTI analysis methods for enhanced application in clinical trials for MS.

Purpose of the Study:

  • To reassess diffusion tensor imaging (DTI) data from the SPRINT-MS trial.
  • To evaluate the utility of specific DTI metrics as outcome measures in progressive multiple sclerosis clinical trials.

Main Methods:

  • Advanced postprocessing of DTI data included corrections for motion and distortions.
  • White matter regions of interest, including the cingulum and cerebellar peduncles, were analyzed.
  • Median radial diffusivity was the primary outcome, analyzed using linear mixed-effects models with Holm correction.

Main Results:

  • Significant differences in the rate of change of radial diffusivity were observed between ibudilast and placebo groups in the cingulum and cerebellar peduncles.
  • Radial diffusivity changes indicated tissue preservation in the treatment group and deterioration in the placebo group.
  • The observed changes were statistically significant (p < 0.04).

Conclusions:

  • Diffusion tensor imaging (DTI) metrics, specifically radial diffusivity in the cingulum and cerebellar peduncles, show potential as outcome measures.
  • These DTI findings suggest a role in assessing treatment efficacy in neuroprotective clinical trials for progressive multiple sclerosis.