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Background Multiple Sclerosis (MS) is an autoimmune disease associated with physical disability, psychological impairment, and cognitive dysfunctions. Consequently, the disease burden is substantial, and treatment choices are limited. In this randomized, double-blind study, we conducted repeated prefrontal electrical stimulation in 40 patients with MS to evaluate mental health variables (quality of life, sleep difficulties, psychological distress) and cognitive dysfunctions (psychomotor speed, working memory, attention/vigilance), marking it as the third largest sample size tDCS research conducted in MS to date. Methods The patients were randomly assigned (block randomization method) to two groups of sham ( n  = 20), or 1.5-mA ( n  = 20) transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (F3) and right frontopolar cortex (Fp2) with anodal and cathodal stimulation respectively (electrode size: 25 cm 2 ). The treatment included 10 sessions of 20 min of stimulation delivered every other day. Outcome measures were MS quality of life, sleep quality, psychological distress, and performance on a neuropsychological test battery dedicated to cognitive dysfunctions in MS (psychomotor speed, working memory, and attention). All outcome measures were evaluated at the pre-intervention and post-intervention assessments. Both patients and technicians delivering the stimulation were unaware of the type of stimulation being used. Results Repeated prefrontal real tDCS significantly improved quality of life and reduced sleep difficulties and psychological distress compared to the sham group. It, furthermore, improved psychomotor speed, attention, and vigilance compared to the sham protocol. Improvement in mental health outcome variables and cognitive outperformance were interrelated and could predict each other. Conclusions Repeated prefrontal and frontopolar tDCS ameliorates secondary clinical symptoms related to mental health and results in beneficial cognitive effects in patients with MS. These results support applying prefrontal tDCS in larger trials for improving mental health and cognitive dysfunctions in MS. Trial registration ClinicalTrials.gov Identifier: NCT06401928.

Introduction: Multiple sclerosis (MS) is an inflammatory demyelinating and neurodegenerative disorder of the central nervous system, which is associated with brain atrophy and volume changes in some brain structures. This study aimed to compare the volume of the basal ganglia, thalamus, cerebellum, and brainstem in patients with relapsing-remitting MS with that of the control group using magnetic resonance imaging (MRI). Methods: In this cross-sectional study, MRI brain scans were obtained from 25 patients with relapsing-remitting MS and 25 healthy control subjects. Volumetric analyses were performed using Brain Suite software. Results: The mean age of the MS and the control groups was 33.96±8.75 and 40.40±8.72, respectively. No statistically significant difference was found in gender (P=0.747). The bilateral putamen and caudate nuclei volumes were significantly higher in the case group than in the control group (P<0.001). Moreover, lower the volume of the brainstem, cerebellum, bilateral thalamus, and globus pallidus were identified in the MS patients compared to the control group (P<0.001). There was an inverse correlation between the disease and treatment duration with the thalamus and cerebellum volume in MS patients (P=0.001). Treatment duration also had an inverse correlation with brainstem volume (P=0.047). Conclusion: The volume of some structures of the brain, including globus pallidus, thalamus, cerebellum, and brainstem is lower in MS and can be one of the markers of disease progression and disability among MS patients.

Multiple sclerosis is an inflammatory demyelinating disease and represents a global health concern. Ocrelizumab, a humanized IgG monoclonal antibody, selectively targets CD20 on B cells and CD20-expressing T cells. This study aimed to compare the efficacy and safety of the biosimilar ocrelizumab candidate (Xacrel) to the originator product (Ocrevus) in Relapsing Multiple Sclerosis (RMS) patients. In this randomized trial, patients received either Xacrel or Ocrevus for 96 weeks. The primary endpoint was the equivalency of the medications in reducing the annualized relapse rate (ARR) at week 48. The secondary endpoints included time to the onset of disability progression confirmed at 12 and 24 weeks, the proportion of relapse-free patients, magnetic resonance imaging (MRI) evaluations, safety assessments, and immunogenicity over 96 weeks. A total of 170 patients were randomized (1:1 ratio). In the per protocol analysis, the upper and lower limits of 95% two-sided confidence intervals of difference between treatments in the 48-week ARR rate were in the predefined margin of − 0.2 to 0.2 (− 0.002; 95% CI − 0.080 to 0.075). The two products were also comparable in terms of other efficacy parameters, safety, and immunogenicity. The results confirmed that Xacrel is equivalent to Ocrevus in terms of 48-week ARR in RMS patients, with no considerable difference in other efficacy parameters and the safety profile during the 96 weeks. The trial was registered in Iranian registry of clinical trials (IRCT) on 10/06/2019 with the registration number of IRCT20150303021315N13 and in Clinicaltrials.gov on 19/07/2021 with the registration code of NCT04966338.

Introduction: Multiple sclerosis (MS) is an inflammatory demyelinating and neurodegenerative disorder of the central nervous system, which is associated with brain atrophy and volume changes in some brain structures.This study aimed to compare the volume of the basal ganglia, thalamus, cerebellum, and brainstem in patients with relapsing-remitting multiple sclerosis with that of the control group using magnetic resonance imaging (MRI).Methods: In this cross-sectional study, MRI brain scans were obtained from 25 patients with relapsing-remitting and 25 healthy control subjects. Volumetric analyses were performed using Brain Suite software.Results: The mean ages ± standard deviation (SD) of the MS and the control groups were 33.96±8.75 and 40.40±8.72, respectively. No statistically significant difference was found in gender distribution (p=0.747). The bilateral putamen and caudate nuclei volumes were significantly higher in the case group than in the control group (p<0.001). Moreover, lower volume of brainstem and cerebellum and bilateral thalamus and globus pallidus were identified in the MS patients, compared to the control group (p<0.001). There was an inverse correlation between the disease and treatment duration with the thalamus and cerebellum volume in MS patients (p=0.001). Treatment duration also had an inverse correlation with brainstem volume (p=0.047).Conclusion:The findings indicate that the volume of some structures of the brain including globus pallidus and thalamus and cerebellum and brainstem is lower in MS and can be one of the markers of disease progression and disability among MS patients.