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Completed
NCT05684016
Assessment of Deep Gray Matter Anatomic Changes in RRMS Patients Treated With Gilenya® With and Without Cognitive Impairment Over a 2 Year Period Using NeuroQuant, NeuroQuarc and ANAM
Conditions: Multiple Sclerosis, Relapsing-Remitting
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 75
Sponsor: George Washington University
Location: United States
Summary
The purpose of the research study is to investigate whether the extent and severity of lesions in the brain as measured by special MRI techniques can distinguish between Multiple Sclerosis (MS) patients with or without memory impairment and also between MS patients and age matched healthy controls.
Eligibility Criteria
Inclusion and Exclusion CriteriaRRMS PatientsInclusion CriteriaMale and Female adult definite RRMS patients with or without cognitive complaintAge range 18-55 years oldPatients treated with Gilenya® (fingolimod) and other immunomodulating MS therapiesAble to provide informed consentExclusion CriteriaPregnant or breastfeeding womenPatients with an infectious diseasePatients with any other medical or neurological condition that could affect cognitionInability to communicate in EnglishPatients with clinically or radiologically isolated syndrome (CIS, RIS)Primary or Secondary Progressive forms of MSCurrent or past medical, neurological or psychiatric disorders (other than MS)Previous illicit substance dependence or substance abusePulse or steroid therapy within 8 weeks or preceding evaluationCurrent major depressive episodeControl PatientsInclusion CriteriaMale and Female adult with normal brain MRI and Neurological ExaminationHeadaches or dizzinessAge range 18-55 yearsAble to provide informed consentExclusion CriteriaPatients with an infectious diseasePatients with any other medical or neurological condition that could affect cognitionInability to provide informed consentInability to communicate in EnglishPregnant or breastfeeding woman
Source: ClinicalTrials.gov (NCT05684016). StuddyBuddy aggregates publicly available trial information.