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Effects of anodal transcranial direct current stimulation over the contralesional hemisphere on motor recovery in subacute stroke patients with severe upper extremity hemiparesis: Study protocol for a randomized controlled trial.

ABSTRACT: INTRODUCTION:Upper extremity motor impairment is one of the major sequelae of stroke, resulting in limitations of activities of daily living. Recently, contralesional cortical activation has been reported to be important for motor recovery in stroke patients with severe upper extremity hemiparesis due to the extensive corticospinal tract involvement. We therefore designed this study to investigate the effects of contralesional anodal transcranial direct current stimulation (tDCS), which induces cortical activation, in stroke patients with severe upper extremity motor impairment. METHODS AND ANALYSIS:We will recruit patients with subacute stroke (<3 months after onset) with unilateral upper extremity weakness who meet the following criteria: Shoulder Abduction and Finger Extension (SAFE) score below 8, Fugl-Meyer Assessment for upper extremity (FMA-UE) score ?25, and absent motor evoked potential (MEP) response on the affected extensor carpi radialis muscle. Subjects will be randomly allocated to either the intervention (n?=?18) or the control group (n?=?18). The intervention group will undergo 10 sessions of robotic arm rehabilitation with simultaneous anodal tDCS over the contralesional premotor area, whereas the control group will receive sham tDCS during the same sessions. One daily session consists of 25 minutes.The primary outcome measure of this study is the Fugl-Meyer Assessment score of the upper extremity; the secondary outcome measures are the Korean version of the Modified Barthel Index, the Brunnstrom stage of the affected arm and hand, the Box and Block Test, the Modified Ashworth Scale, the Manual Muscle Power Test, and the patient's encephalographic laterality index. DISCUSSION:Findings of this study will help to establish an individualized tDCS protocol according to the stroke severity and to find out the EEG parameters to predict the better recovery in subacute stroke patients with severe upper extremity hemiparesis. ETHICS AND DISSEMINATION:The study was approved by the Seoul National University Bundang Hospital Institutional Review Board (IRB No. B-1806-475-006) and will be carried out in accordance with the approved guidelines. The results of the trial will be submitted for publication in a peer-reviewed journal.

SUBMITTER: Lee SH

PROVIDER: S-EPMC7220659 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Effects of anodal transcranial direct current stimulation over the contralesional hemisphere on motor recovery in subacute stroke patients with severe upper extremity hemiparesis: Study protocol for a randomized controlled trial.

Lee Stephanie Hyeyoung SH Kim Won-Seok WS Park Jihong J Kim Junsik J Paik Nam-Jong NJ

Medicine 20200401 14

<h4>Introduction</h4>Upper extremity motor impairment is one of the major sequelae of stroke, resulting in limitations of activities of daily living. Recently, contralesional cortical activation has been reported to be important for motor recovery in stroke patients with severe upper extremity hemiparesis due to the extensive corticospinal tract involvement. We therefore designed this study to investigate the effects of contralesional anodal transcranial direct current stimulation (tDCS), which ...[more]

PMID: 32243365

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Project description:Background and objectivePrediction of voluntary upper extremity (UE) movement recovery is largely unknown in patients with little voluntary UE movement at admission. The present study aimed to investigate (1) the extent and variation of voluntary UE movement recovery, and (2) the best predictive model of the recovery of voluntary UE movement by clinical variables in patients with severe UE paresis.DesignProspective cohort study.Methods140 (out of 590) stroke patients with severe UE paresis completed all assessments. Voluntary UE movement was assessed using the UE subscale of the Stroke Rehabilitation Assessment of Movement (STREAM-UE). Two outcome measures, STREAM-UE scores at discharge (DC(STREAM-UE)) and changes between admission and discharge (Δ(STREAM-UE)), were investigated to represent the final states and improvement of the recovery of voluntary UE movement. Stepwise regression analyses were used to investigate 19 clinical variables and to find the best predictive models of the two outcome measures.ResultsThe participants showed wide variation in both DC(STREAM-UE) and Δ(STREAM-UE). 3.6% of the participants almost fully recovered at discharge (DC(STREAM-UE) > 15). A large improvement (Δ(STREAM-UE) >= 10) occurred in 16.4% of the participants, while 32.9% of the participants did not have any improvement. The four predictors for the DC(STREAM-UE) (R(2) = 35.0%) were 'baseline STREAM-UE score', 'hemorrhagic stroke', 'baseline National Institutes of Health Stroke Scale (NIHSS) score', and 'cortical lesion excluding primary motor cortex'. The three predictors for the Δ(STREAM-UE) (R(2) = 22.0%) were 'hemorrhagic stroke', 'baseline NIHSS score', and 'cortical lesion excluding primary motor cortex'.ConclusionsRecovery of voluntary UE movement varied widely in patients with severe UE paresis after stroke. The predictive power of clinical variables was poor. Both results indicate the complex nature of voluntary UE movement recovery in patients with severe UE paresis after stroke.

Project description:Transcranial direct current stimulation (tDCS) has the potential to improve upper limb motor outcomes after stroke. According to the assumption of interhemispheric inhibition, excessive inhibition from the motor cortex of the unaffected hemisphere to the motor cortex of the affected hemisphere may worsen upper limb motor recovery after stroke. We evaluated the effects of active cathodal tDCS of the primary motor cortex of the unaffected hemisphere (ctDCSM1UH) compared to sham, in subjects within 72 hours to 6 weeks post ischemic stroke. Cathodal tDCS was intended to inhibit the motor cortex of the unaffected hemisphere and hence decrease the inhibition from the unaffected to the affected hemisphere and enhance motor recovery. We hypothesized that motor recovery would be greater in the active than in the sham group. In addition, greater motor recovery in the active group might be associated with bigger improvements in measures in activity and participation in the active than in the sham group. We also explored, for the first time, changes in cognition and sleep after ctDCSM1UH. Thirty subjects were randomized to six sessions of either active or sham ctDCSM1UH as add-on interventions to rehabilitation. The NIH Stroke Scale (NIHSS), Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA), Barthel Index (BI), Stroke Impact Scale (SIS), and Montreal Cognitive Assessment (MoCA) were assessed before, after treatment, and three months later. In the intent-to-treat (ITT) analysis, there were significant GROUP∗TIME interactions reflecting stronger gains in the sham group for scores in NIHSS, FMA, BI, MoCA, and four SIS domains. At three months post intervention, the sham group improved significantly compared to posttreatment in FMA, NIHSS, BI, and three SIS domains while no significant changes occurred in the active group. Also at three months, NIHSS improved significantly in the sham group and worsened significantly in the active group. FMA scores at baseline were higher in the active than in the sham group. After adjustment of analysis according to baseline scores, the between-group differences in FMA changes were no longer statistically significant. Finally, none of the between-group differences in changes in outcomes after treatment were considered clinically relevant. In conclusion, active CtDCSM1UH did not have beneficial effects, compared to sham. These results were consistent with other studies that applied comparable tDCS intensities/current densities or treated subjects with severe upper limb motor impairments during the first weeks post stroke. Dose-finding studies early after stroke are necessary before planning larger clinical trials.

Project description:BACKGROUND:Recovery of voluntary movement is a main rehabilitation goal. Efforts to identify effective upper limb (UL) interventions after stroke have been unsatisfactory. This study includes personalized impairment-based UL reaching training in virtual reality (VR) combined with non-invasive brain stimulation to enhance motor learning. The approach is guided by limiting reaching training to the angular zone in which active control is preserved ("active control zone") after identification of a "spasticity zone". Anodal transcranial direct current stimulation (a-tDCS) is used to facilitate activation of the affected hemisphere and enhance inter-hemispheric balance. The purpose of the study is to investigate the effectiveness of personalized reaching training, with and without a-tDCS, to increase the range of active elbow control and improve UL function. METHODS:This single-blind randomized controlled trial will take place at four academic rehabilitation centers in Canada, India and Israel. The intervention involves 10 days of personalized VR reaching training with both groups receiving the same intensity of treatment. Participants with sub-acute stroke aged 25 to 80 years with elbow spasticity will be randomized to one of three groups: personalized training (reaching within individually determined active control zones) with a-tDCS (group 1) or sham-tDCS (group 2), or non-personalized training (reaching regardless of active control zones) with a-tDCS (group 3). A baseline assessment will be performed at randomization and two follow-up assessments will occur at the end of the intervention and at 1 month post intervention. Main outcomes are elbow-flexor spatial threshold and ratio of spasticity zone to full elbow-extension range. Secondary outcomes include the Modified Ashworth Scale, Fugl-Meyer Assessment, Streamlined Wolf Motor Function Test and UL kinematics during a standardized reach-to-grasp task. DISCUSSION:This study will provide evidence on the effectiveness of personalized treatment on spasticity and UL motor ability and feasibility of using low-cost interventions in low-to-middle-income countries. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02725853 . Initially registered on 12 January 2016.

Project description:Objectives: Either motor training or repetitive transcranial magnetic stimulation (rTMS) could modulate the neural plasticity after stroke. Therefore, synchronizing the two interventions may optimize the efficiency of recovery. In the present study, we aim to investigate the effect of rTMS along with hand grip training on the neurobehavioral and hand functional recovery in one cohort of subacute stroke patients. Methods: Thirty-nine stroke patients were enrolled in a single-center, single-blinded, randomized clinical trial. We tested different intervention effects of rTMS and hand grip training (group A), rTMS alone (group B), and hand grip training alone (group C). For the rTMS-treated groups, patients received 10 consecutive sessions of 5-Hz stimulation over the affected hemisphere with 750 pulses. Jebsen-Taylor Hand Function Test (JTHFT), Fugl-Meyer assessment of upper extremity (FMA-UE), grip strength, modified Barthel index (mBI), and ipsilesional motor evoked potential (iMEP) latency were assessed and compared across the groups. Results: We found that only rTMS along with hand grip training group all improved in JTHFT, FMA-UE, grip strength, and mBI (p ≤ 0.01) compared with the baseline among the three groups. Furthermore, this study demonstrated that rTMS plus hand grip training had much better results in improvement of neurobehavioral outcomes compared to the rTMS alone- and hand grip training alone-treated patients (p < 0.05). However, no significant differences were detected in neurophysiologic outcome between intra-groups and inter-groups (p > 0.05). Conclusion: These proof-of-concept results suggested that rTMS alone with hand grip training was a unique approach to promote hand functional recovery in stroke patients. It provided important information to design a large-scale multi-center clinical trial to further demonstrate the efficiency of the combination of central and peripheral stimulation. Clinical Trial Registration: http://www.chictr.org.cn (#ChiCTR1900023443).

Project description:BackgroundActivity limitations of the upper extremity are a common finding for individuals living with stroke. Mental practice (MP) is a training method that uses cognitive rehearsal of activities to improve performance of those activities.ObjectivesTo determine if MP improves the outcome of upper extremity rehabilitation for individuals living with the effects of stroke.Search strategyWe searched the Cochrane Stroke Group Trials Register (November 2010), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, November 2009), PubMed (1965 to November 2009), EMBASE (1980 to November 2009), CINAHL (1982 to November 2009), PsycINFO (1872 to November 2009), Scopus (1996 to November 2009), Web of Science (1955 to November 2009), the Physiotherapy Evidence Database (PEDro), CIRRIE, REHABDATA, ongoing trials registers, and also handsearched relevant journals and searched reference lists.Selection criteriaRandomised controlled trials involving adults with stroke who had deficits in upper extremity function.Data collection and analysisTwo review authors independently selected trials for inclusion. We considered the primary outcome to be the ability of the arm to be used for appropriate tasks (i.e. arm function).Main resultsWe included six studies involving 119 participants. We combined studies that evaluated MP in addition to another treatment versus the other treatment alone. Mental practice in combination with other treatment appears more effective in improving upper extremity function than the other treatment alone (Z = 3.48, P = 0.0005; standardised mean difference (SMD) 1.37; 95% confidence interval (CI) 0.60 to 2.15). We attempted subgroup analyses, based on time since stroke and dosage of MP; however, numbers in each group were small. We evaluated the quality of the evidence with the PEDro scale, ranging from 6 to 9 out of 10; we determined the GRADE score to be moderate.Authors' conclusionsThere is limited evidence to suggest that MP in combination with other rehabilitation treatment appears to be beneficial in improving upper extremity function after stroke, as compared with other rehabilitation treatment without MP. Evidence regarding improvement in motor recovery and quality of movement is less clear. There is no clear pattern regarding the ideal dosage of MP required to improve outcomes. Further studies are required to evaluate the effect of MP on time post stroke, volume of MP that is required to affect the outcomes and whether improvement is maintained long-term. Numerous large ongoing studies will soon improve the evidence base.

Dataset Information

Effects of anodal transcranial direct current stimulation over the contralesional hemisphere on motor recovery in subacute stroke patients with severe upper extremity hemiparesis: Study protocol for a randomized controlled trial.

Publications

Effects of anodal transcranial direct current stimulation over the contralesional hemisphere on motor recovery in subacute stroke patients with severe upper extremity hemiparesis: Study protocol for a randomized controlled trial.

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