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Intermittent Theta Burst Stimulation (iTBS) for Treatment of Chronic Post-Stroke Aphasia: Results of a Pilot Randomized, Double-Blind, Sham-Controlled Trial.
Szaflarski, JP, Nenert, R, Allendorfer, JB, Martin, AN, Amara, AW, Griffis, JC, Dietz, A, Mark, VW, Sung, VW, Walker, HC, et al
Medical science monitor : international medical journal of experimental and clinical research. 2021;:e931468
Abstract
BACKGROUND Research indicates intermittent theta burst stimulation (iTBS) is a potential treatment of post-stroke aphasia. MATERIAL AND METHODS In this double-blind, sham-controlled trial (NCT01512264) participants were randomized to receive 3 weeks of sham (G₀), 1 week of iTBS/2 weeks of sham (G₁), 2 weeks of iTBS/1 week of sham (G₂), or 3 weeks of iTBS (G₃). FMRI localized residual language function in the left hemisphere; iTBS was applied to the maximum fMRI activation in the residual language cortex in the left frontal lobe. FMRI and aphasia testing were conducted pre-treatment, at ≤1 week after completing treatment, and at 3 months follow-up. RESULTS 27/36 participants completed the trial. We compared G0 to each of the individual treatment group and to all iTBS treatment groups combined (G₁₋₃). In individual groups, participants gained (of moderate or large effect sizes; some significant at P<0.05) on the Boston Naming Test (BNT), the Semantic Fluency Test (SFT), and the Aphasia Quotient of the Western Aphasia Battery-Revised (WAB-R AQ). In G₁₋₃, BNT, and SFT improved immediately after treatment, while the WAB-R AQ improved at 3 months. Compared to G₀, the other groups showed greater fMRI activation in both hemispheres and non-significant increases in language lateralization to the left hemisphere. Changes in IFG connectivity were noted with iTBS, showing differences between time-points, with some of them correlating with the behavioral measures. CONCLUSIONS The results of this pilot trial support the hypothesis that iTBS applied to the ipsilesional hemisphere can improve aphasia and result in cortical plasticity.
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Effects of a food preparation program on dietary well-being for stroke patients with dysphagia: A pilot study.
Lin, SC, Lin, KH, Tsai, YC, Chiu, EC
Medicine. 2021;(25):e26479
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BACKGROUND Dysphagia is one of the common issues observed in patients with stroke. Stroke patients with dysphagia have to eat blended food or similar types of food for each meal, resulting in dietary dissatisfaction. The purpose of this study was to investigate the effects of a food preparation program on dietary well-being for stroke patients with dysphagia. METHODS This study was a pilot randomized clinical trial. Twenty-two patients were assigned randomly into the food preparation group (n = 11) and control group (n = 11). The food preparation group received oral motor exercises, recognition of food texture and thickener, and hands-on food preparation for 6 weeks. Outcome measures included the Dietary Well-Being Scale, brief version of the World Health Organization Quality of life, Swallowing Quality of Life Questionnaire, and Mini Nutritional Assessment. RESULTS Patients in the food preparation group showed significant improvements in the Dietary Well-Being Scale, psychological and environmental domains of the brief version of the World Health Organization Quality of life (P = .001-.024) with small to large effect sizes (success rate difference = 0.23-0.46). The Swallowing Quality of Life Questionnaire and Mini Nutritional Assessment displayed non-significant differences (P = .053-.092) and revealed small to moderate effect sizes (success rate difference = 0.23-0.32). CONCLUSIONS The food preparation program showed a positive impact on dietary well-being and a potential improvement in the health-related quality of life, quality of life related to the process of swallowing, and nutritional status for stroke patients with dysphagia. We recommend that stroke patients with dysphagia receive adequate knowledge and hands-on food preparation training to increase their dietary intake and well-being.
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An emulated target trial analysis based on Medicare data suggested non-inferiority of Dabigatran versus Rivaroxaban.
Mei, H, Wang, J, Ma, S
Journal of clinical epidemiology. 2021;:28-37
Abstract
OBJECTIVES Rivaroxaban and Dabigatran were the first two non-vitamin K antagonist oral anticoagulants (NOACs) for preventing stroke among non-valvular Atrial Fibrillation patients. This article aimed to evaluate the relative efficacy and safety of Rivaroxaban versus Dabigatran. STUDY DESIGN AND SETTING An emulated target trial analysis was conducted based on Medicare, in which we constructed three "randomized clinical trials" with well-defined inclusion/exclusion criteria, treatment regimens, and analysis procedures. We analyzed the individual trials, examined temporal variations, and generated unified results via pooled analysis. RESULTS With a two-year data collection window (2012-2013), 70,129 subjects were enrolled in the three emulated trials, with 36,269 and 34,089 in the Rivaroxaban and Dabigatran arms, respectively. Dabigatran (the reference group for hazard ratio - HR) was superior regarding time to any primary event (including ischemic stroke, other thromboembolic events, major bleeding, and death; HR 1.232, P-value 0.0025), major bleeding (HR 1.187, P-value <0.0001), and mortality (HR 1.488, P-value <0.0001). Differences regarding stroke and other thromboembolic events were not significant. CONCLUSION Dabigatran was found as superior for the Medicare patients with multiple chronic conditions. Temporal variations, which had been largely neglected in the literature, were observed. This study may provide new insight into treating AF with NOACs.
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Can the early use of botulinum toxin in post stroke spasticity reduce contracture development? A randomised controlled trial.
Lindsay, C, Ispoglou, S, Helliwell, B, Hicklin, D, Sturman, S, Pandyan, A
Clinical rehabilitation. 2021;(3):399-409
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OBJECTIVE Does early treatment of spasticity with botulinum-toxin (BoNTA), in (hyper)acute stroke patients without arm-function, reduce contractures and improve function. DESIGN Randomised placebo-controlled-trial. SETTING Specialised stroke-unit. PARTICIPANTS & INTERVENTION Patients with an Action Research Arm Test (ARAT) grasp-score⩽2 who developed spasticity within six-weeks of a first stroke were randomised to receive injections of: 0.9%sodium-chloride solution (placebo) or onabotulinumtoxin-A (treatment). OUTCOME-MEASURES Spasticity, contractures, splint use and arm function (ARAT) were taken at baseline, 12-weeks post-injection and six-months after stroke. Additionally, spasticity and contractures were measured at weeks-two, four and six post-injection. RESULTS Ninety three patients were randomised. Mean time to intervention was 18-days (standard deviation = 9.3). Spasticity was lower in the treatment group with difference being significant between week-2 to 12 (elbow) and week-2 to 6 (wrist). Mean-difference (MD) varied between -8.5(95% CI -17 to 0) to -9.4(95% CI -14 to -5) µV.Contracture formation was slower in the treatment group. Passive range of motion was higher in the treatment group and was significant at week-12 (elbow MD6.6 (95% CI -0.7 to -12.6)) and week-6 (wrist MD11.8 (95% CI 3.8 to 19.8)). The use of splints was lower in the treatment group odds ratio was 7.2 (95% CI 1.5 to 34.1) and 4.2 (95% CI 1.3 to 14.0) at week-12 and month-6 respectively.Arm-function was not significantly different between the groups MD2.4 (95% CI -5.3 to 10.1) and 2.9 (95% CI -5.8 to 11.6) at week-12 and month-6 respectively. CONCLUSION BoNTA reduced spasticity and contractures after stroke and effects lasted for approximately 12-weeks. BoNTA reduced the need for concomitant contracture treatment and did not interfere with recovery of arm function. TRIAL REGISTRATION EudraCT (2010-021257-39) and ClinicalTrials.gov-Identifier: NCT01882556.
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Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial.
Ni, J, Chen, H, Chen, G, Ji, Y, Yi, F, Zhang, Z, Yang, Y, Wu, J, Cai, X, Shao, B, et al
BMC neurology. 2020;(1):282
Abstract
BACKGROUND Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 h of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke. METHODS Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram. RESULTS In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p = 0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups. CONCLUSIONS The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported. TRIAL REGISTRATION Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827 . Retrospectively registered June 13, 2019.
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Interim effects of salt substitution on urinary electrolytes and blood pressure in the China Salt Substitute and Stroke Study (SSaSS).
Huang, L, Tian, M, Yu, J, Li, Q, Liu, Y, Yin, X, Wu, JH, Marklund, M, Wu, Y, Li, N, et al
American heart journal. 2020;:136-145
Abstract
The Salt Substitute and Stroke Study is an ongoing 5-year large-scale cluster randomized trial investigating the effects of potassium-enriched salt substitute compared to usual salt on the risk of stroke. The study involves 600 villages and 20,996 individuals in rural China. Intermediate risk markers were measured in a random subsample of villages every 12 months over 3 years to track progress against key assumptions underlying study design. Measures of 24-hour urinary sodium, 24-hour urinary potassium, blood pressure and participants' use of salt substitute were recorded, with differences between intervention and control groups estimated using generalized linear mixed models. The primary outcome of annual event rate in the two groups combined was determined by dividing confirmed fatal and non-fatal strokes by total follow-up time in the first 2 years. The mean differences (95% CI) were -0.32 g (-0.68 to 0.05) for 24-hour urinary sodium, +0.77 g (+0.60 to +0.93) for 24-hour urinary potassium, -2.65 mmHg (-4.32 to -0.97) for systolic blood pressure and +0.30 mmHg (-0.72 to +1.32) for diastolic blood pressure. Use of salt substitute was reported by 97.5% in the intervention group versus 4.2% in the control group (P<.0001). The overall estimated annual event rate for fatal and non-fatal stroke was 3.2%. The systolic blood pressure difference and the annual stroke rate were both in line with the statistical assumptions underlying study design. The trial should be well placed to address the primary hypothesis at completion of follow-up.
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Cilostazol Versus Aspirin in Ischemic Stroke Patients With High-Risk Cerebral Hemorrhage: Subgroup Analysis of the PICASSO Trial.
Kim, BJ, Kwon, SU, Park, JH, Kim, YJ, Hong, KS, Wong, LKS, Yu, S, Hwang, YH, Lee, JS, Lee, J, et al
Stroke. 2020;(3):931-937
Abstract
Background and Purpose- Although cilostazol has shown less hemorrhagic events than aspirin, only marginal difference was observed in hemorrhagic stroke events among patients at high risk for cerebral hemorrhage. To identify patients who would most benefit from cilostazol, this study analyzed interactions between treatment and subgroups of the PICASSO trial (Prevention of Cardiovascular Events in Asian Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage). Methods- Ischemic stroke patients with a previous intracerebral hemorrhage or multiple microbleeds were randomized to treatment with cilostazol or aspirin and followed up for a mean 1.8 years. Efficacy, defined as the composite of any stroke, myocardial infarction, and vascular death, and safety, defined as the incidence of hemorrhagic stroke, were analyzed in the 2 groups. Interactions between treatment and age, sex, presence of hypertension and diabetes mellitus, index of high-risk cerebral hemorrhage, and white matter lesion burden were analyzed for primary and key secondary outcomes. Changes in vital signs and laboratory results were compared in the 2 groups. Results- Among all 1534 patients enrolled, a significant interaction between treatment group and index of high risk for cerebral hemorrhage on hemorrhagic stroke (P for interaction, 0.03) was observed. Hemorrhagic stroke was less frequent in the cilostazol than in the aspirin group in patients with multiple microbleeds (1 versus 13 events; hazard ratio, 0.08 [95% CI, 0.01-0.61]; P=0.01). A marginal interaction between treatment group and white matter change on any stroke (P for interaction, 0.08) was observed. Cilostazol reduced any stroke significantly in patients with mild (5 versus 16 events; hazard ratio, 0.36 [95% CI, 0.13-0.97]; P=0.04)-to-moderate (16 versus 32 events; hazard ratio, 0.50 [95% CI, 0.29-0.92]; P=0.03) white matter changes. Heart rate and HDL (high-density lipoprotein) cholesterol level were significantly higher in the cilostazol group than in the aspirin group at follow-up. Conclusions- Cilostazol may be more beneficial for ischemic stroke patients with multiple cerebral microbleeds and before white matter changes are extensive. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT01013532.
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Individualized nutritional treatment for acute stroke patients with malnutrition risk improves functional independence measurement: A randomized controlled trial.
Otsuki, I, Himuro, N, Tatsumi, H, Mori, M, Niiya, Y, Kumeta, Y, Yamakage, M
Geriatrics & gerontology international. 2020;(3):176-182
Abstract
AIM: The aim of the present study was to investigate the effects of individualized nutritional treatment on the activities of daily living of acute stroke patients. METHODS This was a randomized controlled study. The eligibility criteria were acute stroke, age >65 years and the presence of malnutrition risk. Between September 2016 and December 2017, 128 patients were assigned to either the standard or intensive group (individualized nutritional treatment). The intensive group received energy that was calculated using the Harris-Benedict equation. The main outcome measures were the total functional independence measurement gain from the time of assignment to the time of discharge from the recovery hospital or at 3 months after the stroke onset, and motor and cognitive functional independence measurement gains. RESULTS Compared with the standard group, the intensive group had significantly higher median energy intake (P < 0.001); significantly greater functional independence measurement gains in the total score (42 vs. 22; P = 0.02) and motor subscore (P = 0.01), but similar cognitive subscore. CONCLUSION Individualized nutritional treatment improved the activities of daily living of older acute stroke patients with malnutrition risk. Geriatr Gerontol Int 2019; ••: ••-••.
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The Effects of Timing of a Leucine-Enriched Amino Acid Supplement on Body Composition and Physical Function in Stroke Patients: A Randomized Controlled Trial.
Ikeda, T, Morotomi, N, Kamono, A, Ishimoto, S, Miyazawa, R, Kometani, S, Sako, R, Kaneko, N, Iida, M, Kawate, N
Nutrients. 2020;(7)
Abstract
The combination of exercise and nutritional intervention is widely used for stroke patients, as well as frail or sarcopenic older persons. As previously shown, supplemental branched chain amino acids (BCAAs) or protein to gain muscle mass has usually been given just after exercise. This study investigated the effect of the timing of supplemental BCAAs with exercise intervention on physical function in stroke patients. The participants were randomly assigned to two groups based on the timing of supplementation: breakfast (n = 23) and post-exercise (n = 23). The supplement in the breakfast group was provided at 08:00 with breakfast, and in the post-exercise group it was provided just after the exercise session in the afternoon at 14:00-18:00. In both groups, the exercise intervention was performed with two sessions a day for two months. The main effects were observed in body fat mass (p = 0.02, confidence interval (CI): 13.2-17.7), leg press strength (p = 0.04, CI: 94.5-124.5), and Berg balance scale (p = 0.03, CI: 41.6-52.6), but no interaction with intake timing was observed. Although the effect of the timing of supplementation on skeletal muscle mass was similar in both groups, BCAA intake with breakfast was effective for improving physical performance and decreasing body fat mass. The results suggest that a combination of BCAA intake with breakfast and an exercise program was effective for promoting rehabilitation of post-stroke patients.
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Rationale, Design, and Implementation of Intensive Risk Factor Treatment in the CREST2 Trial.
Turan, TN, Voeks, JH, Chimowitz, MI, Roldan, A, LeMatty, T, Haley, W, Lopes-Virella, M, Chaturvedi, S, Jones, M, Heck, D, et al
Stroke. 2020;(10):2960-2971
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BACKGROUND AND PURPOSE The CREST2 trial (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis) is comparing intensive medical management (IMM) alone to IMM plus revascularization with carotid endarterectomy or transfemoral carotid artery stenting for preventing stroke or death within 44 days after randomization or ipsilateral ischemic stroke thereafter. There are extensive clinical trial data on outcomes after revascularization of asymptomatic carotid stenosis, but not for IMM. As such, the experimental treatment in CREST2 is IMM, which is described in this article. METHODS IMM consists of aspirin 325 mg/day and intensive risk factor management, primarily targeting systolic blood pressure <130 mm Hg (initially systolic blood pressure <140 mm Hg) and LDL (low-density lipoprotein) cholesterol <70 mg/dL. Secondary risk factor targets focus on tobacco smoking, non-HDL (high-density lipoprotein), HbA1c (hemoglobin A1c), physical activity, and weight. Risk factor management is performed by site personnel and a lifestyle coaching program delivered by telephone. We report interim risk factor data on 1618 patients at baseline and last follow-up through 24 months. RESULTS The mean baseline LDL of 80.5 mg/dL improved to 66.7 mg/dL. The mean baseline systolic blood pressure of 139.7 mm Hg improved to 130.3 mm Hg. The proportion of patients in-target improved from 43% to 61% for systolic blood pressure <130 mm Hg and from 45% to 67% for LDL<70 mg/dL (both changes P<0.001). CONCLUSIONS The rigorous multimodal approach to intensive stroke risk factor management in CREST2 has resulted in significant improvements in risk factor control that will enable a comparison of cutting-edge medical care to revascularization in patients with asymptomatic carotid stenosis. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02089217.