Dataset Information

The efficacy and safety of acupuncture combined with language training for motor aphasia after stroke: study protocol for a multicenter randomized sham-controlled trial.

ABSTRACT:

Background

Motor aphasia after stroke is a common and intractable complication of stroke. Acupuncture and language training may be an alternative and effective approach. However, the efficacy of acupuncture and language training for motor aphasia after stroke has not been confirmed. The main objectives of this trial are to evaluate the effectiveness and safety of acupuncture and low-intensity, low-dose language training in treating ischemic motor aphasia after stroke from 15 to 90 days.

Methods

This is a multicenter randomized sham-controlled clinical trial. We will allocate 252 subjects aged between 45 and 75 years diagnosed with motor aphasia after stroke with an onset time ranging from 15 to 90 days into two groups randomly in a 1:1 ratio. Patients in the experimental group will be treated with "Xing-Nao Kai-Qiao" acupuncture therapy plus language training, and those in the control group will be treated with sham-acupoint (1 cun next to the acupoints) acupuncture therapy plus language training. All the patients will be given acupuncture and language training for 6 weeks, with a follow-up evaluation 6 weeks after the end of the treatment and 6 months after the onset time. The patients will mainly be evaluated using the Western Aphasia Battery and Chinese Functional Communication Profile, and the incidence of treatment-related adverse events at the 2nd, 4th, and 6th weeks of treatment will be recorded. The baseline characteristics of the patients will be summarized by group, the chi-squared test will be used to compare categorical variables, and repeated measures of analysis of variance or a linear mixed model will be applied to analyze the changes measured at different time points.

Discussion

The present study is designed to investigate the effectiveness and safety of traditional acupuncture therapy and language training in ischemic motor aphasia after stroke and explore the correlation between the treatment time and clinical effect of acupuncture. We hope our results will help doctors understand and utilize acupuncture combined with language training.

Trial registration

ChiCTR ChiCTR1900026740 . Registered on 20 October 2019.

SUBMITTER: Deng S

PROVIDER: S-EPMC9245218 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Importance:Aphasia is a debilitating language disorder for which behavioral speech therapy is the most efficient treatment, but therapy outcomes are variable and full recovery is not always achieved. It remains unclear if adjunctive brain stimulation (anodal transcranial direct current stimulation [A-tDCS]) applied during aphasia therapy can improve outcomes. Objective:To examine the futility of studying A-tDCS as an adjunctive intervention during speech therapy to improve speech production (naming) for individuals with long-term poststroke aphasia. Design, Setting, and Participants:Double-blinded, prospective randomized clinical trial using a futility design to test adjunctive A-tDCS during speech therapy. The setting was an outpatient clinic. Enrollment of individuals began in August 2012 and was completed in March 2017, and the duration of follow-up was 6 months. Analyses began in April 2017. The study recruited from a volunteer sample, and 89 patients were screened. Patients with long-term (>6 months) aphasia due to 1 previous left hemisphere stroke were enrolled. In comparing A-tDCS and sham tDCS, patients were matched based on site (University of South Carolina or Medical University of South Carolina), baseline age, type of aphasia, and aphasia severity. Interventions:Outpatient speech therapy for 3 weeks (15 sessions, 45 minutes each) combined with either A-tDCS vs sham tDCS applied to preserved left temporal lobe regions. Main Outcomes and Measures:The primary outcome was the ability to name common objects, assessed twice before and after therapy. Results:A total of 74 patients were enrolled. Participants had a mean (SD) age of 60 (10) years, had 15 (2) years of education, and were 44 (40) months from stroke onset. There were 52 men (70%) and 62 non-Hispanic white individuals (84%). Most were retired or not employed (59 [80%]). Broca aphasia was the most common aphasia type (39 [52.7%]). The adjusted mean (SE) change from pretreatment baseline in correct naming was 13.9 (2.4) words (95% CI, 9.0-18.7) for A-tDCS and 8.2 (2.2) words (95% CI, 3.8-12.6) for sham tDCS, with mean (SE) A-tDCS difference of 5.7 (3.3) words (95% CI, -0.9 to 12.3), indicating a relative 70% increase in correct naming for A-tDCS relative to sham. The futility hypothesis P value was .90, indicating failure to reject the null hypothesis and, therefore, providing no evidence that further study of A-tDCS is futile. No serious adverse events were associated with A-tDCS. Conclusions and Relevance:Our findings provide motivation to proceed with another trial to study the effect of A-tDCS on the outcome of aphasia treatment in individuals poststroke. Anodal tDCS during speech therapy is feasible and potentially transformative for aphasia treatment and should be further studied. Trial Registration:ClinicalTrials.gov Identifier: NCT01686373.