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.
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 using the Brief International Cognitive Assessment for MS (BICAMS) and the Modified Fatigue Impact Scale (MFIS), respectively. Importantly, the cognitive and fatigue assessments administered in this study are not currently part of the standard clinical care for MS patients on OCR. 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 MS management.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
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.
John D. Dingell VA Medical Center
Detroit, Michigan, United States
Change in global cognitive performance
Global cognitive performance will be assessed using a composite z-score, derived from 3 standardized tests: 1. CVLT (California Verbal Learning Test): Measures verbal learning and memory. Immediate Recall Max score= 80, Min = 0. Short and Long-Delay Recall: Max = 16 each, Min = 0. Recognition: Max = 16, Min = 0. Higher scores = better memory and learning ability. Lower scores = memory/learning impairment. 2. BVMT-R (Brief Visuospatial Memory Test-Revised): Measures visuospatial learning/ memory; 6 abstract designs × 3 learning trials. Max total learning = 36, Min = 0. Delayed Recall: Max = 12, Min = 0. Recognition: Max = 6, Min = 0. Higher = better visuospatial memory. Lower = difficulty in visual memory. 3. SDMT (Symbol Digit Modalities Test): Measures information processing speed, attention, working memory. Max = 110, Min = 0. Higher = better processing, Lower = slower processing Individual raw scores will be standardized, averaged, and compared between baseline and 12 months.
Time frame: Baseline to 12 months.
Change in fatigue impact (Modified Fatigue Impact Scale, MFIS)
Change in total score on the Modified Fatigue Impact Scale (MFIS; 21 items). Item responses range 0-4 and total score ranges 0-84, with higher scores indicating greater fatigue impact. The outcome is the difference between MFIS total at baseline and over a 12-month period; higher score = greater fatigue impact (worse) and lower score = less fatigue impact (better).
Time frame: Baseline to 12 months.
Change in health-related quality of life (Multiple Sclerosis Quality of Life-54; MSQOL-54, physical and mental composite scores)
Change in the MSQOL-54 physical health composite and mental health composite scores (each transformed 0-100, higher = better). Scores are computed per MSQOL-54 scoring manual by transforming subscale raw scores to 0-100 scales and averaging the relevant subscales to produce the two composite scores. The outcome is the difference between baseline and 12-month composite scores for each domain; positive values indicate improvement in health-related quality of life.
Time frame: Baseline to 12 months
Change in patient-reported physical and mental health (Patient-Reported Outcomes Measurement Information System, 29-item profile; PROMIS-29)
Change in PROMIS-29 domain T-scores (physical function, fatigue, anxiety, depression, sleep disturbance, social roles, pain interference) and pain intensity (0-10). PROMIS domain scores are reported as T-scores (mean=50, SD=10); higher scores indicate greater symptom burden for negative domains (fatigue, pain, etc.) and better health for positive domains (physical function, social roles). The outcome will report domain-specific changes from baseline to 12 months; directionality is indicated per domain. Higher = worse for negative domains (anxiety, depression, fatigue, pain interference, sleep disturbance, pain intensity). Higher = better for positive domains (physical function, social roles).
Time frame: Baseline to 12 months
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