Assessing the Effects of Ongoing Ocrelizumab (OCR) Therapy on Fatigue and Cognition in Veterans With Multiple Sclerosis: Utilizing Cognitive Assessment Scales, and Patient-Reported Outcome Measures
Anza Memon
Summary
This study seeks to assess the effects of long-term ocrelizumab therapy on fatigue (extreme tiredness) as well as cognition (thinking and reasoning skills, such as memory, learning and attention), in veterans with multiple sclerosis. The evaluation will involve cognitive assessment scales (to assess memory, attention and learning abilities), clinical evaluations (to assess nerve function and ability to move), and patient-reported outcome measures (in which you will answer questions about your tiredness, sleep and how you function in daily life). These assessments will occur at baseline (visit 1), 6 month (Visit-2) and 12 months (visit 3) to track changes over time.
Description
This is a prospective, interventional study involving 30 subjects who have been diagnosed with multiple sclerosis (MS) and being treated with ocrelizumab (OCR) for at least one year. This study will be performed at the John D. Dingell, VA Medical Center. All participants will require full informed consent prior to any study- related procedures. All aspects of the study and informed consent forms will be reviewed and approved by the institutional Review Board (IRB). MS patients who have been on OCR- for MS treatment, and enrolled in this study will undergo cognitive and fatigue assessments usin…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18-75, men and women. * Confirmed diagnosis of Multiple Sclerosis (MS) (relapsing or progressive forms). * Expanded Disability Status Scale score between 0 and 7.5. * On continuous ocrelizumab therapy for at least 1 year. * Women of childbearing potential: Must agree to remain abstinent or use acceptable contraceptive methods during the study and for 6 months after the. last ocrelizumab dose; must have a negative pregnancy test before enrollment. Exclusion Criteria: * Patients without a confirmed diagnosis of MS based on McDonald 2017 Criteria. * Not on ocrelizumab…
Interventions
- OtherMultiple Sclerosis patients who have been on Ocrelizumab will undergo cognitive and fatigue assessments
The cognitive and fatigue assessments administered in this study are not currently part of the standard clinical care for multiple sclerosis patients on Ocrelizumab. By prospectively assigning participants to undergo these additional assessments, this aspect of the study is considered investigational, and findings may contribute to clinical decision-making regarding the incorporation of cognitive and fatigue assessments into routine management of multiple sclerosis conditions.
Location
- John D. Dingell VA Medical CenterDetroit, Michigan