Disease-modifying therapies for T1 hypointense lesions (Black Holes) volume in patients with multiple sclerosis: Protocol for a systematic review and meta-analysis

Rationale A major part of diagnosis and follow-up in patients with multiple sclerosis is based on MRI evaluations. As T1-hypointense lesions represent neural destruction or axonal loss and anticipate irreversible disability in the patients, evaluation of the effects of Disease-modifying therapies (DMTs) on the volume of black holes seems necessary. Objectives To evaluate the effects of FDA approved disease-modifying therapies (DMTs) on T1 hypointense lesions (Black Holes) volume in patients with multiple sclerosis (MS) Data sources We will search MEDLINE (through Ovid), Embase, and CENTRAL. We won’t consider any timeframe, language, or geographical restrictions. Methods We will include only randomized controlled trials (RCTs) that have evaluated the effects of DMTs on black holes mean volume in adult patients diagnosed with any phenotype of multiple sclerosis (MS) in comparison to the placebo, routine care, or no treatment regimen. We will assess the risk of bias in the primary studies using the Revised Cochrane risk-of-bias tool for randomized trials (RoB2). Data will be synthesized based on the random-effects model and results will be plotted on a forest plot. Heterogeneity will be assessed using I2 statistics. If feasible, we will also perform subgroup analyses for each DMT. Funding This study is not funded. Registration PROSPERO submission ID: 262883.