Tecfidera Diffusion Tensor Imaging

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of this study is to explore the effect of dimethyl fumarate on gray matter (GM) pathology, as measured by changes in diffusion-tensor imaging (DTI) of the thalamus in patients with relapsing multiple sclerosis (MS). The secondary objective of this study is to investigate the effect of dimethyl fumarate on evolution of microstructural changes in normal appearing white matter (NAWM), as measured by DTI.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University at Buffalo
• Treatments: Dimethyl Fumarate

Criteria

Inclusion Criteria:

• MS patients diagnosed with MS according to the McDonald criteria

• MS patients having a relapsing disease course

• Starting treatment with dimethyl fumarate therapy for at least one month

• Having standard of care 1.5T or 3T MRI scan obtained at baseline (time of start of dimethyl fumarate) and at the 12 and 24 months after starting dimethyl fumarate. In case of healthy controls, having 2 MRI scans with a minimum of 24 months apart

• Have DTI sequence at all timepoints

• At least 18 years of age

• None of the exclusion criteria

Exclusion Criteria:

• Patients who had a relapse within 30 days prior to MRI scan date

• Patients who received steroid treatment within 30 days prior to the MRI scan date

• Women who were pregnant during the time of the retrospective study or are pregnant/lactating at the time of the prospective arm

All healthy controls will be part of the retrospective arm.