Effects of dimethyl fumarate (Tecfidera) on white matter integrity and functional brain adaptation and cognition in Multiple Sclerosis - Dimethyl fumarate, advanced neuroimaging and cognition in MS

Vrije Universiteit Medisch Centrum0 个研究点目标入组 90 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•To be eligible to participate in this study, candidates must meet the following
•eligibility criteria at baseline:1. Ability to understand the purpose and risks
•of the study and provide signed and dated informed consent and authorization to
•use protected health information (PHI) in accordance with national and local
•subject privacy regulations;
•2. All participants should be 18-65 years of age;
•3. All participants need to meet the safety criteria to undergo an MRI
•examination;
•4. All participants should have sufficient visual acuity and motor skills to
•perform the fMRI task;For the patient groups specifically:
•5. Only patients with (active) RRMS will be included;
•6. Patients using other drugs influencing the CNS (such as anti-depressants,
•stimulants, anti-epileptica etc) should be stable on this medication using it
•for at least 6 months;

•Candidates will be excluded from study entry if any of the following exclusion
•criteria exist at baseline:
•1. Unable or unwilling to provide informed consent.
•2. Presence or history of psychiatric or neurological disease (for patients:
•neurological disease other than MS) that is expected to affect outcome measures
•(will be discussed with the principal investigator and neurologist);
•3. Presence of contra-indications for MRI;
•4. History or presence of alcohol or drug abuse;
•5. Participation in other (scientific) studies using cognitive or physical
•training interventionsFor the patient groups specifically:
•6. Patients with disease categorized as primary progressive, secondary
•progressive or progressive relapsing;
•7. Patients that had a relapse and steroid treatment within the four weeks
•prior to examination.

发起方