Clinical Efficacy of Acupuncture Treatment in Combination With RehaCom Cognitive Training for Improving Cognitive Function in Stroke: A 2 × 2 Factorial Design Randomized Controlled Trial

Jiang, Cai; Yang, Shanli; Tao, Jing; Huang, Jia; Li, Yinyan; Ye, Haicheng; Chen, Shanjia; Hong, Wenjun; Chen, Lidian

doi:10.1016/j.jamda.2016.07.021

Cited by 57 publications

(55 citation statements)

References 49 publications

(36 reference statements)

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“…In this study, we chose two acupoints—“Baihui” (GV20) and “Shenting” (GV24), which are situated on the Du meridian—for our study. In the TCM theoretical system of acupuncture, the Du Meridian is the center of the brain and is closely related to the mind [ 44 ]. Baihui (DU 20) and Shenting (DU24) are closely related to brain function and are widely used in the treatment of mental and emotional illnesses [ 45 ].…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of theta and gamma electroacupuncture for post-stroke patients on working memory and electrophysiology: study protocol for a double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial

Ren

Zhao

et al. 2020

Trials

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Background Practitioners of complementary and alternative medicine have suggested that electroacupuncture (EA) could improve post-stroke cognitive impairment, based on the clinical evidence. This study protocol is aimed at showing the effectiveness of theta and gamma EA for post-stroke patients on working memory (WM) and electrophysiology. Methods After assessing their eligibility, 66 patients with stroke will be enrolled from two Chinese medicine hospitals and randomly divided into theta frequency EA group, gamma frequency EA group, and sham-EA group according to the ratio of 1:1:1. All patients will receive 20 sessions of EA procedures for 4 weeks. Patients in three groups will receive EA at two same acupoints in the head: Baihui (GV20) and Shenting (GV24). The frequency of the three groups of EA is set as follows: 6 Hz (theta-EA group), 40 Hz (gamma-EA group), and no current through the electrodes (sham EA). Patients and assessors will be blinded throughout the entire study. The primary outcome is the performance accuracy of 1-back task which is a frequently used measure of WM in cognitive neuroscience research contexts. Secondary outcome measures will include the response time of 1-back task, the Rivermead Behavioral Memory Test, Trail Making Test, Loewenstein Occupational Therapy Cognitive Assessment Scale, modified Barthel Index, and electroencephalogram (EEG) signals during 1-back tasks. A blinding index will be assessed. Data will be statistically analyzed by one-way ANOVA, at 5% of significance level. Discussion We expect this double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial to explore the effectiveness of theta and gamma EA therapy, compared with sham EA, for post-stroke WM. Trial registration Chinese Clinical Trial Registry, ChiCTR2000031995. Registered on 17 April 2020.

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Section: Discussionmentioning

confidence: 99%

Effectiveness of theta and gamma electroacupuncture for post-stroke patients on working memory and electrophysiology: study protocol for a double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial

Ren

Zhao

et al. 2020

Trials

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“…In this procedure, we used the formula for calculating the sample size of two sample rates for disordered classified data. Taking the results of previous research with a similar study design of acupuncture arm [ 15 ] (RR = 80%, OR = 15%) into consideration, a sample size of 100 patients (50 for each group) should be recruited. Allowing 20% attrition, the recruited sample size for this RCT will be of 120 patients (60 in each group).…”

Section: Methods and Designmentioning

confidence: 99%

Efficacy of electrical acupuncture on vascular cognitive impairment with no dementia: study protocol for a randomized controlled trial

Tian

Soto-Aguliar

et al. 2018

Trials

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BackgroundVascular cognitive impairment with no dementia (VCIND), manifested mainly as mild impairment of concentration and executive function, is the early phase of vascular dementia (VD). Currently, there is no specific treatment for VCIND. We hypothesize that electrical acupuncture can improve the mental and motor functions of patients with VCIND. Thus, we designed this randomized controlled trial to test this hypothesis by comparing the therapeutic effect of electrical acupuncture versus sham acupuncture in patients with VCIND.Method/DesignIn this single-center 3-year study, 120 eligible patients will be recruited and randomly assigned to receive electrical acupuncture treatment (n = 60) or sham acupuncture (n = 60) for 8 consecutive weeks (24 sessions in total), with the same acupoint prescription (DU20, EX-HN3, DU24, DU17, DU26, EX-HN1, HT7, PC6, GB20, SP6). The primary assessment is the Montreal Cognitive Assessment. The secondary assessments are the Modified Barthel Index and Event-Related Potential. All outcomes will be assessed at baseline, endpoint, and follow-up at 8 and 24 weeks after the end of treatment.DiscussionIf the outcome confirms the effectiveness and safety of electrical acupuncture in treating VCIND, this treatment is expected to be promoted in clinical practice to treat such patients.Trial RegistrationChinese Clinical Trial Registry identifier: ChiCTR-IIR-17011513; Registered on 27 May 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2458-1) contains supplementary material, which is available to authorized users.

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“…Based on the randomized controlled trial report published by Jiang C in 2016 [43] , the sample size was estimated with MoCA as the main outcome. After 12 weeks of treatment, the difference of MoCA between pre-therapy and post-therapy in the conventional rehabilitation group (without acupuncture) was 2.83 ± 1.13, and that of MoCA between pre-therapy and post-therapy in acupuncture group was 1.33 ± 1.20.…”

Section: Sample Sizementioning

confidence: 99%

Acupuncture for amnestic mild cognitive impairment (aMCI): study protocol for a pilot multicenter, randomized, parallel controlled trial

Zhang¹,

Kuang²,

Tang³

et al. 2020

Preprint

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Background: Patients with amnesic mild cognitive impairment (aMCI) are more likely to develop Alzheimer's disease (AD) than corresponding age normal population. Because AD is irreversible, early intervention for aMCI patients seems important and urgent. We have designed a pilot multicenter, randomized, parallel controlled trial to assess the efficacy and safety of acupuncture on aMCI, and explore the feasibility of acupuncture in the treatment of aMCI, so as to provide a reference for large-sample clinical trials in the next stage. Method: We designed a pilot multicenter, randomized, parallel controlled trial. This trial aims to test the feasibility of carrying out a large-sample clinical trial. In this trial, 50 eligible patients with aMCI will be included and allocated to acupuncture group (n = 25) or sham acupuncture group (n = 25) at random. Subjects will accept treatment 2 times a week for 12 weeks continuously, with a total of 24 treatment sessions. We will select six acupoints (GV20, GV14, bilateral BL18 , bilateral BL23). For the clinical outcomes, the primary outcome is Montreal cognitive assessment (MoCA), which will be assessed from baseline to the end of this trial. And the secondary outcomes are Mini-mental State Examination (MMSE), Delayed Story Recall (DSR), Clinical Dementia Rating scale (CDR), Global Deterioration Scale (GDS), Activity of Daily Life (ADL), Alzheimer's Disease Assessment Scale-Cognitive Section (ADAS-cog), brain Magnetic Resonance Imaging (MRI) , brain functional Magnetic Resonance Imaging (fMRI) and Event-related potential (ERP) P300, which will be assessed before and after treatment. In addition, we will asses the safety outcomes from baseline to the end of this trial and feasibility outcome after treatment. We will evaluate neuropsychological assessment scale (MoCA, MMSE, ADAS-cog) at 3 months and 6months after treatment. Discussion: This pilot trial aims to explore the feasibility of the trial, and verify essential information of its efficacy and safety. This pilot study will provide a preliminary basis for carrying out a larger clinical trial of acupuncture on aMCI in near future. Trial registration: Chinese Clinical Trial Registry , ChiCTR1900021557. Registered on 27 February 2019, http://www.chictr.org.cn/showproj.aspx?proj=35460. Keywords: amnestic Mild Cognitive Impairment , Acupuncture, Clinical trial

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Clinical Efficacy of Acupuncture Treatment in Combination With RehaCom Cognitive Training for Improving Cognitive Function in Stroke: A 2 × 2 Factorial Design Randomized Controlled Trial

Cited by 57 publications

References 49 publications

Effectiveness of theta and gamma electroacupuncture for post-stroke patients on working memory and electrophysiology: study protocol for a double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial

Effectiveness of theta and gamma electroacupuncture for post-stroke patients on working memory and electrophysiology: study protocol for a double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial

Efficacy of electrical acupuncture on vascular cognitive impairment with no dementia: study protocol for a randomized controlled trial

Acupuncture for amnestic mild cognitive impairment (aMCI): study protocol for a pilot multicenter, randomized, parallel controlled trial

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