Dataset Information

Effect of Combined Treatment with MLC601 (NeuroAiDTM) and Rehabilitation on Post-Stroke Recovery: The CHIMES and CHIMES-E Studies.

ABSTRACT: BACKGROUND AND PURPOSE:MLC601 has been shown in preclinical studies to enhance neurorestorative mechanisms after stroke. The aim of this post hoc analysis was to assess whether combining MLC601 and rehabilitation has an effect on improving functional outcomes after stroke. METHODS:Data from the CHInese Medicine NeuroAiD Efficacy on Stroke (CHIMES) and CHIMES-Extension (CHIMES-E) studies were analyzed. CHIMES-E was a 24-month follow-up study of subjects included in CHIMES, a multi-centre, double-blind placebo-controlled trial which randomized subjects with acute ischemic stroke, to either MLC601 or placebo for 3 months in addition to standard stroke treatment and rehabilitation. Subjects were stratified according to whether they received or did not receive persistent rehabilitation up to month (M)3 (non- randomized allocation) and by treatment group. The modified Rankin Scale (mRS) and Barthel Index were assessed at month (M) 3, M6, M12, M18, and M24. RESULTS:Of 880 subjects in CHIMES-E, data on rehabilitation at M3 were available in 807 (91.7%, mean age 61.8 ± 11.3 years, 36% female). After adjusting for prognostic factors of poor outcome (age, sex, pre-stroke mRS, baseline National Institute of Health Stroke Scale, and stroke onset-to-study-treatment time), subjects who received persistent rehabilitation showed consistently higher treatment effect in favor of MLC601 for all time points on mRS 0-1 dichotomy analysis (ORs 1.85 at M3, 2.18 at M6, 2.42 at M12, 1.94 at M18, 1.87 at M24), mRS ordinal analysis (ORs 1.37 at M3, 1.40 at M6, 1.53 at M12, 1.50 at M18, 1.38 at M24), and BI ?95 dichotomy analysis (ORs 1.39 at M3, 1.95 at M6, 1.56 at M12, 1.56 at M18, 1.46 at M24) compared to those who did not receive persistent rehabilitation. CONCLUSIONS:More subjects on MLC601 improved to functional independence compared to placebo among subjects receiving persistent rehabilitation up to M3. The larger treatment effect of MLC601 was sustained over 2 years which supports the hypothesis that MLC601 combined with rehabilitation might have beneficial and sustained effects on neuro-repair processes after stroke. There is a need for more data on the effect of combining rehabilitation programs with stroke recovery treatments.

SUBMITTER: Suwanwela NC

PROVIDER: S-EPMC6214602 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Effect of Combined Treatment with MLC601 (NeuroAiDTM) and Rehabilitation on Post-Stroke Recovery: The CHIMES and CHIMES-E Studies.

Suwanwela Nijasri C NC Chen Christopher L H CLH Lee Chun Fan CF Young Sherry H SH Tay San San SS Umapathi Thirugnanam T Lao Annabelle Y AY Gan Herminigildo H HH Baroque Ii Alejandro C AC Navarro Jose C JC Chang Hui Meng HM Advincula Joel M JM Muengtaweepongsa Sombat S Chan Bernard P L BPL Chua Carlos L CL Wijekoon Nirmala N de Silva H Asita HA Hiyadan John Harold B JHB Wong Ka Sing Lawrence KSL Poungvarin Niphon N Eow Gaik Bee GB Venketasubramanian Narayanaswamy N

Cerebrovascular diseases (Basel, Switzerland) 20180905 1-2

<h4>Background and purpose</h4>MLC601 has been shown in preclinical studies to enhance neurorestorative mechanisms after stroke. The aim of this post hoc analysis was to assess whether combining MLC601 and rehabilitation has an effect on improving functional outcomes after stroke.<h4>Methods</h4>Data from the CHInese Medicine NeuroAiD Efficacy on Stroke (CHIMES) and CHIMES-Extension (CHIMES-E) studies were analyzed. CHIMES-E was a 24-month follow-up study of subjects included in CHIMES, a multi- ...[more]

PMID: 30184553

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Project description:BackgroundDespite progress in stroke therapy (e.g., revascularisation interventions by thrombolysis and/or thrombectomy, organised stroke care), many stroke survivors will have impairment of neurological function. We aimed to compare the cost-effectiveness of an oral natural formulation, MLC601, versus placebo in functional recovery among subjects receiving standard of care after an ischemic stroke of intermediate severity assessed with NIH Stroke Scale at baseline (b-NIHSS 8-14).MethodsA Markov cohort model with a 2-year time horizon was developed to simulate patients from a published randomised placebo-controlled clinical trial of MLC601 in their post-stroke functional recovery assessed by modified Rankin Score (mRS), from a health system perspective. Transition probabilities were derived from a multi-centre clinical trial in South East Asia. As cost and utility data were not collected in the trial, therefore we extracted them from the published literature. The main outcomes were incremental cost, incremental quality-adjusted life-year (QALY) gained, and incremental cost-effectiveness ratio (ICER). Besides base-case and sensitivity analyses, we performed subgroup analyses to explore the heterogeneity of patients with poor-prognosis factors (b-NIHSS 10-14, stroke onset to treatment time > 48 h, rehabilitation during first 3 month). All costs are expressed in 2022 Euro and USD, with an annual discount rate of 3% applied to costs and QALYs.ResultsBase-case analysis showed that MLC601 was cost-effective compared with placebo, with €5,080 saved and 0.45 QALY gained, resulting in an ICER of -€11,352.50 per QALY gained. Similarly, results from subgroup analyses indicated that the use of MLC601 was a dominant strategy in all subgroups with poor-prognosis factors. Sensitivity analyses revealed the results were robust.ConclusionCompared with placebo on top of standard stroke care, MLC601 was cost-effective in post-stroke functional recovery over two years. Due to the lack of cost and utility data from the study population, the results might not be generalizable to other settings. Further studies with country-specific data are needed to confirm the results of this study.Trial registrationURL http://www.Clinicaltrialsgov . Unique identifier NCT00554723 November 7, 2007.

Project description:Background:Tailored rehabilitation programs for stroke patients cannot be made without knowledge of their recovery potential. The aim of this study is to characterize the functional recovery patterns of ischemic stroke (IS) and intracerebral hemorrhage (ICH) patients under post-acute care stroke rehabilitation. Methods:This retrospective study analyzed the data of patients enrolled in the Post-Acute Care-Cerebrovascular Disease (PAC-CVD) rehabilitation program, which provides an individualized 1- to 3-hour intensive physical, occupational, and speech and language therapy for post-acute stroke patients in Taoyuan Chang Gung Memorial hospital in Taiwan. Our primary endpoint measure was Barthel Index (BI), and secondary endpoint measures included other 12 functional measures. Results:A total of 489 patients were included for analysis. Patients with stroke history had less BI improvement than those who suffered their first-ever stroke. In first-ever stroke patients who had completed 6 to 12 weeks of PAC-CVD program, subcortical ICH patients had greater BI, quality of life, sensation, and balance improvements, and had greater late-phase recovery than their IS counterparts. In IS patients, those with age >75 had less BI improvement; those with National Institute of Health Stroke Scale (NIHSS) score 1-5 had greater Motor Activity Log quality of use (MAL-quality) improvement than those with NIHSS score >5; those with Mini-Mental State Examination (MMSE) score ?24 had greater BI and instrumental activities of daily living (IADL) improvement. Using the general linear model, previous stroke (ß: -6.148, p=0.01) and subcortical ICH (ß: 5.04, p=0.03) were factors associated with BI improvement. Conclusion:Subcortical ICH patients have greater functional improvement and greater late-phase recovery than their IS counterparts following PAC rehabilitation. More studies are needed to validate our findings and unravel the underlying mechanisms of stroke recovery to optimize the treatment strategy following a stroke.

Project description:Post-stroke depression and cognitive impairment are common conditions affecting patients after stroke. Serotonin is a neurotransmitter involved in modulating, among others, mood, cognition, learning, and memory. Sub-optimal serotonin activity may be in part responsible for cognitive deficits seen in depression. In this pilot study serotonin levels were evaluated in 29 patients with sub-acute stroke before and after a rehabilitation treatment (consisting of a program of upper limb robotic rehabilitation in addition to conventional physical therapy treatment). We employed the Back Depression Inventory scale to evaluate symptoms of depression, and specific tools to evaluate cognitive functions. We found a significant reduction of the serotonin levels after rehabilitation in the whole group (T0: 85.9 ± 92.4 ng/mL; T1: 61.9 ± 58.4 ng/mL; p = 0.0018), as well as in the subgroup of patients untreated with Selective Serotonin Reuptake Inhibitors (SRRI), (mean serotonin at T0: 154.0 ± 102.3 ng/mL; mean serotonin at T1: 92.9. ± 68.7 ng/mL at T1; p = 0.005). We also found a correlation with cognitive assessment: in particular, the change from baseline of the serotonin (ΔSerotonin) was correlated with the changes from baseline of the Rey's Figure (ΔROCF) (r = 0.535; p < 0.05), the Tower of London (ΔToL) (subscore point: r = 0.621; p < 0.005; subscore time: r = -0.619; p < 0.005) meaning that a serotonin levels decrease is associated with a worsening of cognitive functions. Considering patients treated and untreated with SSRIs separately, in patients treated with SSRIs (n = 16) we found only a positive correlation between ∆Serotonin and ∆ToL (subscore point: r= 0.587; p = 0.045), whereas in patients untreated with SSRIs (n = 13) we found a positive correlations between ΔSerotonin and ΔROCF (r = 0.700; p = 0.036), ∆Stroop (subscore time: r = 0.750; p = 0.020) and ∆Tol (subscore point: r = 0.740; p = 0.023) and a negative correlation between ΔSerotonin and ∆Tol (subscore time: r= -0.833; p = 0.005). These results suggest that variation of serotonin levels should be monitored in patients during a rehabilitation program, not only for their relationship with depression symptoms, but also for the correlation with cognitive performance.

Project description:BackgroundRehabilitation medicine is facing a new development phase thanks to a recent wave of rigorous clinical trials aimed at improving the scientific evidence of protocols. This phenomenon, combined with new trends in personalised medical therapies, is expected to change clinical practice dramatically. The emerging field of Rehabilomics is only possible if methodologies are based on biomedical data collection and analysis. In this framework, the objective of this work is to develop a systematic review of machine learning algorithms as solutions to predict motor functional recovery of post-stroke patients after treatment.MethodsWe conducted a comprehensive search of five electronic databases using the Patient, Intervention, Comparison and Outcome (PICO) format. We extracted health conditions, population characteristics, outcome assessed, the method for feature extraction and selection, the algorithm used, and the validation approach. The methodological quality of included studies was assessed using the prediction model risk of bias assessment tool (PROBAST). A qualitative description of the characteristics of the included studies as well as a narrative data synthesis was performed.ResultsA total of 19 primary studies were included. The predictors most frequently used belonged to the areas of demographic characteristics and stroke assessment through clinical examination. Regarding the methods, linear and logistic regressions were the most frequently used and cross-validation was the preferred validation approach.ConclusionsWe identified several methodological limitations: small sample sizes, a limited number of external validation approaches, and high heterogeneity among input and output variables. Although these elements prevented a quantitative comparison across models, we defined the most frequently used models given a specific outcome, providing useful indications for the application of more complex machine learning algorithms in rehabilitation medicine.

Dataset Information

Effect of Combined Treatment with MLC601 (NeuroAiDTM) and Rehabilitation on Post-Stroke Recovery: The CHIMES and CHIMES-E Studies.

Publications

Effect of Combined Treatment with MLC601 (NeuroAiDTM) and Rehabilitation on Post-Stroke Recovery: The CHIMES and CHIMES-E Studies.

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