scholarly journals A Randomised Computer-assisted Rehabilitation Trial of Attention in Pediatric Multiple Sclerosis: A Post-hoc Analysis.

2021 ◽  
Author(s):  
Marta Simone ◽  
Rosa Gemma Viterbo ◽  
Lucia Margari ◽  
Pietro Iaffaldano
Keyword(s):  
Multiple Sclerosis ◽  
Cognitive Decline ◽  
Computer Training ◽  
Computer Assisted ◽  
Information Processing Speed ◽  
Post Hoc Analysis ◽  
Clinically Significant ◽  
Post Hoc ◽  
Attention Impairment ◽  
Clinical Meaningfulness

Abstract Background: Cognitive decline is one of the most remarkable features of Multiple Sclerosis (MS) and particularly in pediatric onset MS (POMS). The Simbol Digit Modalities Test (SDMT), a simple, brief measure of information processing speed (IPS) has been proposed and it is increasingly used to explore cognitive functions in MS clinical trials. Recently a 4-point worsening on the SDMT score has been demonstrated to significantly correlate with a clinically meaningful cognitive decline.Methods: The primary objective of this post-hoc analysis of a randomised computer-assisted rehabilitation trial for attention impairment in POMS was to test the clinical meaningfulness of the changes of SDMT scores by applying a 4-point SDMT cut-off. POMS exposed to specific computer training (ST) and nonspecific training (nST) were compared. All analyses were post hoc and not pre-specified. To evaluate the clinical meaningfulness of longitudinal changes over time of the SDMT in the ST and nST groups we applied a categorization of the delta SDMT scores (delta SDMT: SDMT score at T1 – SDMT score at T0) as follow: between -3 and 3 = not clinically significant; ≤ - 4 = clinically significant worsening; ≥ 4 = clinically significant improvement. The proportion of patients reporting a clinically significant SMDT improvement were compared between the 2 groups by using the chi-square test.Results: Twenty-five % of POMS reported no clinically significant changes, 12.5% a clinically significant worsening and 62.5% patients a clinically significant improvement in the SDMT score at the end of the training program. The proportion of patients reporting a clinically significant improvement of the SDMT was significantly (p=0.008) higher (100%) in patients exposed to the ST in comparison to that (25%) in nST group. Conclusions: In our RCT the use of the 4-point SDMT cut-off allows us to demonstrate the clinical meaningfulness of the results obtained by a home-based computerized program for retraining attention dysfunction in POMS patients with attention impairment. Further studies are needed to confirm the clinical validity of this cut-off and its applicability in the routine clinical practice setting

scholarly journals A Randomized Computer-Assisted Rehabilitation Trial of Attention in Pediatric Multiple Sclerosis: A Post Hoc Analysis

2021 ◽  
Vol 11 (5) ◽  
pp. 637
Author(s):  
Marta Simone ◽  
Rosa Gemma Viterbo ◽  
Lucia Margari ◽  
Pietro Iaffaldano
Keyword(s):  
Multiple Sclerosis ◽  
Cognitive Rehabilitation ◽  
Computer Training ◽  
Computer Assisted ◽  
Meaningful Improvement ◽  
Remarkable Feature ◽  
Post Hoc Analysis ◽  
Clinically Significant ◽  
Post Hoc ◽  
Clinical Meaningfulness

Cognitive impairment (CI) is a remarkable feature in pediatric-onset multiple sclerosis (POMS). The Symbol Digit Modalities Test (SDMT) is increasingly used to explore CI in MS. Recently, a four-point worsening on the SDMT score has been demonstrated to correlate with a clinically meaningful cognitive worsening in adult MS. We conducted a post hoc analysis of a randomized computer-assisted rehabilitation trial for attention impairment in POMS to test the clinical meaningfulness of the changes in SDMT scores at the end of the trial (delta SDMT). A four-point SDMT cut-off was applied. POMS patients exposed to specific computer training (ST) and non-specific training (nST) were compared. Data of 16 POMS (9 females, age 15.75 ± 1.74 years) patients were analyzed. At the end of the trial, 25% of patients reported no clinically significant changes (−3 to 3), 12.5% a clinically significant worsening (≤−4) and 62.5% a clinically significant improvement (≥4) in the delta SDMT. The proportion of patients reporting a clinically meaningful improvement was significantly (p = 0.008) higher (100%) in patients exposed to ST in comparison to those (25%) exposed to nST. The use of the four-point SDMT cut-off may be useful to assess the clinical meaningfulness of results from cognitive rehabilitation trials.

scholarly journals Dalfampridine improves slowed processing speed in multiple sclerosis patients with mild motor disability: post hoc analysis of a randomized controlled trial

2021 ◽  
Vol 14 ◽  
pp. 175628642110112
Author(s):  
Carlo Pozzilli ◽  
Luca Prosperini ◽  
Silvia Tommasin ◽  
Claudio Gasperini ◽  
Elena Barbuti ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Processing Speed ◽  
Controlled Trial ◽  
Dominant Hand ◽  
Information Processing Speed ◽  
Double Blind ◽  
Motor Disability ◽  
Post Hoc Analysis ◽  
Multiple Sclerosis Patients ◽  
Post Hoc

Objective: To evaluate baseline characteristics predictive of improving information processing speed in multiple sclerosis (MS) and the relationship between cognitive and motor response to dalfampridine (DA) treatment. Methods: This is a post hoc analysis of a randomized, double-blind, placebo-controlled trial in patients with MS randomized to receive DA 10 mg or placebo twice daily for 12 consecutive weeks. Here, we include only data from 71 patients in the arm treated with DA. According to the median value of Symbol Digit Modalities Test (SDMT) response, patients were categorized as “full responders” (FR) or “partially responders” (PR). Results: There was higher possibility of being FR in the presence of a baseline lower Expanded Disability Status Scale [odds ratio (OR) 0.69; 95% confidence interval (CI) 0.5–0.97, p = 0.034], a higher Multiple Sclerosis Functional Composite value (OR 1.37; 95%CI 1.05–1.8, p = 0.022), a lower Timed 25-Foot Walk Test (OR 0.76; 95% CI 0.6–0.98, p = 0.033), and a lower 9-Hole Peg Test with dominant hand (OR 0.92; 95% CI 0.86–0.99, p = 0.029). FR group did not show any significant improvement of motor performance compared with PR group. Conclusion: The current analysis shows that in MS patients with cognitive deficit, the greatest improvement in SDMT provided by DA was observed in patients with milder motor impairment; cognitive and motor responses to treatments are not related. Trial registration: EU Clinical Trials Register; ID 2013-002558-64 ( https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002558-64 )

scholarly journals The efficacy of cladribine tablets in CIS patients retrospectively assigned the diagnosis of MS using modern criteria: Results from the ORACLE-MS study

2017 ◽  
Vol 3 (4) ◽  
pp. 205521731773280 ◽  
Author(s):  
Mark S Freedman ◽  
Thomas P Leist ◽  
Giancarlo Comi ◽  
Bruce AC Cree ◽  
Patricia K Coyle ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinically Isolated Syndrome ◽  
Expanded Disability Status Scale ◽  
Post Hoc Analysis ◽  
Nominal Significance ◽  
Disability Status ◽  
Definite Multiple Sclerosis ◽  
Clinically Definite Multiple Sclerosis ◽  
Post Hoc ◽  
In Cis

Background Multiple sclerosis (MS) diagnostic criteria have changed since the ORACLE-MS study was conducted; 223 of 616 patients (36.2%) would have met the diagnosis of MS vs clinically isolated syndrome (CIS) using the newer criteria. Objective The objective of this paper is to assess the effect of cladribine tablets in patients with a first clinical demyelinating attack fulfilling newer criteria (McDonald 2010) for MS vs CIS. Methods A post hoc analysis for subgroups of patients retrospectively classified as fulfilling or not fulfilling newer criteria at the first clinical demyelinating attack was conducted. Results Cladribine tablets 3.5 mg/kg ( n = 68) reduced the risk of next attack or three-month confirmed Expanded Disability Status Scale (EDSS) worsening by 74% vs placebo ( n = 72); p = 0.0009 in patients meeting newer criteria for MS at baseline. Cladribine tablets 5.25 mg/kg ( n = 83) reduced the risk of next attack or three-month confirmed EDSS worsening by 37%, but nominal significance was not reached ( p = 0.14). In patients who were still CIS after applying newer criteria, cladribine tablets 3.5 mg/kg ( n = 138) reduced the risk of conversion to clinically definite multiple sclerosis (CDMS) by 63% vs placebo ( n = 134); p = 0.0003. Cladribine tablets 5.25 mg/kg ( n = 121) reduced the risk of conversion by 75% vs placebo ( n = 134); p < 0.0001. Conclusions Regardless of the criteria used to define CIS or MS, 3.5 mg/kg cladribine tablets are effective in patients with a first clinical demyelinating attack. ClinicalTrials.gov registration: The ORACLE-MS study (NCT00725985).

Sign in / Sign up

Export Citation Format

Share Document