Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2015
Sample-size calculations for short-term proof-of-concept studies of tissue protection and repair in multiple sclerosis lesions via conventional clinical imaging.
Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 20 citations in OpenAlex.
- Distinct characteristics and severity of brain magnetic resonance imaging lesions in women and men with multiple sclerosis assessed using verified texture analysis measures.Frontiers in neurology · 2023Article
- Quantitative magnetization transfer imaging in relapsing-remitting multiple sclerosis: a systematic review and meta-analysis.Brain communications · 2022Review
- Experimental design and sample size considerations in longitudinal magnetic resonance imaging-based biomarker detection for multiple sclerosis.Statistical methods in medical research · 2020Article
- Association of Chronic Active Multiple Sclerosis Lesions With Disability In Vivo.JAMA neurology · 2019Article
- Prognostic value of white matter lesion shrinking in early multiple sclerosis: An intuitive or naïve notion?Brain and behavior · 2019Observational
- Potential role of iron in repair of inflammatory demyelinating lesions.The Journal of clinical investigation · 2019Article
- Spatiotemporal distribution of fibrinogen in marmoset and human inflammatory demyelination.Brain : a journal of neurology · 2018Article
- Multiple Sclerosis.The New England journal of medicine · 2018Review
- A LAG FUNCTIONAL LINEAR MODEL FOR PREDICTION OF MAGNETIZATION TRANSFER RATIO IN MULTIPLE SCLEROSIS LESIONS.The annals of applied statistics · 2016Article
- Persistent 7-tesla phase rim predicts poor outcome in new multiple sclerosis patient lesions.The Journal of clinical investigation · 2016Observational
- Advanced MRI and staging of multiple sclerosis lesions.Nature reviews. Neurology · 2016Review
- Removing inter-subject technical variability in magnetic resonance imaging studies.NeuroImage · 2016Article
- Relating multi-sequence longitudinal intensity profiles and clinical covariates in incident multiple sclerosis lesions.NeuroImage. Clinical · 2016Article
- PREVAIL: Predicting Recovery through Estimation and Visualization of Active and Incident Lesions.NeuroImage. Clinical · 2016Article
- Researchers Expand Focus on Progressive Forms Of Multiple Sclerosis: Efforts to Pinpoint the Beginning of Disease May Yield Clues to Treatment.P & T : a peer-reviewed journal for formulary management · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundNew multiple sclerosis (MS) lesion activity on magnetic resonance imaging (MRI) can test immunomodulatory therapies in proof-of-concept trials. Comparably powerful endpoints to assess tissue protection or repair are lacking.
objectiveThe objective of this paper is to report sample-size calculations for assessment of new lesion recovery.
methodsIn two sets of six active MS cases, new lesions were observed by monthly MRI for approximately 12 months. Averages and quartiles of normalized (proton density/T1/T2 weighted) and quantitative (T1/T2 and mean diffusivity maps for dataset 1, T2 and magnetization transfer ratio maps for dataset 2) measures were used to compare the lesion area before lesion appearance to afterward. A linear mixed-effects model incorporating lesion- and participant-specific random effects estimated average levels and variance components for sample-size calculations.
resultsIn both datasets, greatest statistical sensitivity was observed for the 25th percentile of normalized proton density-weighted signal. At 3T, using new lesions ⩾15 mm(3), as few as nine participants/arm may be required for a six-month placebo-controlled add-on trial postulating a therapeutic effect size of 20% and statistical power of 90%.
conclusionLesion recovery is a powerful outcome measure for proof-of-concept clinical trials of tissue protection and repair in MS. The trial design requires active cases and is therefore best implemented near disease onset.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.