Advanced neuroimaging, biomarkers, clinical and cognitive functioning in early MS

Bristol Myers Squibb0 个研究点目标入组 180 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•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. Sufficient Dutch proficiency to be able to comprehend and to perform the neuropsychological examination;
•4. All participants need to meet the safety criteria to undergo an MRI examination;
•For the patients specifically:
•5. Only patients that are recently (up to 12 months) diagnosed with clinically definite MS according to the 2017 revision of the McDonald MS criteria will be included;
•6. Only patients with (active) relapsing-remitting disease course will be included;
•7. All types of disease modifying treatment for MS are allowed.

•1. Unable or unwilling to provide informed consent;
•2. Presence or history of alcohol or drug abuse;
•3. Presence or history of psychiatric or neurological disease of the CNS (for patients: neurological disease other than MS) that is expected to affect any of the outcome measures (will be discussed with the principal investigator and neurologist);
•4. Presence of contra-indications for MRI;
•5. Participation in other (scientific) studies using cognitive or physical training programs (interventions other than standard care) at baseline to avoid noise.
•For the patient groups specifically:
•6. Patients with disease categorized as clinically isolated syndrome, primary progressive, secondary progressive or progressive relapsing;
•7. Relapses or steroid treatment less than four weeks prior to the visits. Visits of included patients experiencing a relapse will be postponed if possible;
•8. Patients undergoing a cognitive relapse. Visits of included patients experiencing a cognitive relapse will be postponed if possible.

发起方

Bristol Myers Squibb