Binocular Low-Contrast Acuity and the Symbol Digit Modalities Test Improve the Ability of the Multiple Sclerosis Functional Composite to Predict Disease in Pediatric Multiple Sclerosis (P4.022)
OBJECTIVE: To determine whether the three-component Multiple Sclerosis Functional Composite (MSFC) or a modified MSFC with low-contrast letter acuity (LCLA) and the symbol digit modalities test (SDMT) captures disability in pediatric MS. BACKGROUND: Outcome measures to capture disability, such as the MSFC, were developed for adult MS clinical trials. The addition of binocular LCLA or substitution of the SDMT for the paced auditory serial addition task (PASAT) to the MSFC in adults improved the capacity to capture neurologic impairment. Outcome metrics for pediatric MS have not yet been established. DESIGN/METHODS: The MSFC (25-foot timed walk [25FTW], 9-hole peg test [9HPT], children’s PASAT [ChiPASAT]) as well as the SDMT and binocular LCLA (Sloan charts, 1.25[percnt] contrast), were administered to children with MS (disease onset RESULTS: Nineteen pediatric MS subjects and seventeen healthy controls were enrolled. The MSFC composite score for the traditional 3 components did not differ between the groups (p=0.199). Replacing the ChiPASAT with binocular 1.25[percnt] LCLA (OR 13.9, p=0.036) or the SDMT (OR 16.5, p=0.041) distinguished the two groups. A modified MSFC-4 with the SDMT replacing the ChiPASAT and including binocular 1.25[percnt] LCLA had the greatest capacity to distinguish pediatric MS from controls (OR 123.5, p=0.016). CONCLUSIONS: A modified MSFC (25FTW, 9HPT, SMDT, and binocular 1.25[percnt] LCLA) is more sensitive than the traditional MSFC to capture the subtle impairments that characterize pediatric MS and should be considered for future pediatric MS trials. Study Supported by: National Multiple Sclerosis Society, American Brain Foundation, and the National Institutes of Health. Disclosure: Dr. Waldman has received royalty payments from UpToDate. Dr. Chahin has nothing to disclose. Dr. Banwell has received personal compensation for activities with Novartis as an MRI reviewer. Dr. Banwell has received personal compensation in an editorial capacity for Multiple Sclerosis and Related Disorders. Dr. Liu has received personal compensation for activities with Ipsen as a consultant. Dr Balcer received personal compensation from Biogen Idec and consulting for Biogen Idec, Vaccinex and Genzyme. She is on a clinical trial advisory board for Biogen-Idec.,