RT Journal Article
SR Electronic
T1 Technical Feasibility of Implementing Multifocal VEP for Multicenter Clinical Trials (P02.245)
JF Neurology
JO Neurology
FD Lippincott Williams & Wilkins
SP P02.245
OP P02.245
VO 80
IS 7 Supplement
A1 Cadavid, Diego
A1 Levin, Netta
A1 Costello, Fiona
A1 Rahilly, Alisa
A1 Klistorner, Alexandr
YR 2013
UL http://n.neurology.org/content/80/7_Supplement/P02.245.abstract
AB OBJECTIVE: Determine the feasibility of implementing mfVEP in multicentre studies as a standardized tool to assess demyelination in ON.BACKGROUND: Multiple sclerosis (MS) often presents as acute optic neuritis (ON), reflecting optic nerve demyelination. Multifocal visual evoked potentials (mfVEP) can identify a range of optic nerve damage, including demyelination, and may detect remyelination.DESIGN/METHODS: mfVEP evaluation was performed on 8 male, 8 female subjects (8 normal controls; 8 ON patients (6 with MS) at 2 international sites: 8 subjects per site). Two tests were performed per subject within 7-10 days. Usable traces were required in 80% of segments/eye. Analyses included the proportion of identifiable responses, test-retest reliability, latency comparisons between subject groups and between affected/ fellow eyes in ON patients and performance by study site. Object from Motion (OFM) tests were performed in Israel.RESULTS: A median 95% mfVEP responses was identifiable in each site. Test-retest reliability was high (R^2=0.98 for both right and left eyes). Compared with the latency in control eyes (mean +/- standard deviation, 145.9 +/- 4.6 msec), latencies for affected eyes (165.8 +/- 13.2) and fellow eyes (151.1 +/- 6.2) of ON patients were significantly longer (P<0.00001 and P=0.002, respectively). Performance was similar between study sites. Asymmetry with OFM correlated with asymmetry of mfVEP (R^2=0.31).CONCLUSIONS: mfVEP demonstrated intra-site and inter-site reliability and reproducibility. Latencies in control eyes were significantly different from affected and fellow eyes of ON patients. These data support the use of mfVEP as a tool in multicentre clinical trials to assess damage from central nervous system demyelination. mfVEP may be also be useful to measure remyelination during natural recovery or in clinical trials of remyelinating therapies. Based on these data, mfVEP may be an efficacy end point in the phase 2 multicenter trial of the anti-LINGO-1 compound BIIB033.Supported by: Biogen Idec.Disclosure: Dr. Cadavid has received personal compensation for activities with Biogen Idec as an employee. Dr. Levin has nothing to disclose. Dr. Costello has received personal compensation for activities with Serono, Roche Diagnostics Corporation, and Celgene. Dr. Rahilly has received personal compensation for activities Biogen Idec as an employee. Dr. Klistorner has reveived personal compensation for activities with Biogen Idec.Tuesday, March 19 2013, 7:30 am-12:00 pm