Is The Memory Repair Protocol A Hoax

• Study protocol
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• Published: 04 Nov 2022

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

• Meng Ren^{2  na1},
• Jing-Jun Zhao^{ii  na1},
• Jia-Jia Wuⁱ,
• Si-Cong Zhang¹,
• Yan-Biao Zhong^two,
• Shu-Tian Xuⁱⁱ,
• Zhong-Yao Caoⁱⁱⁱ,
• Zhi-Qing Zhou²,
• Yuan-Li Li² &
• Chun-Lei Shan ORCID: orcid.org/0000-0002-2742-1281 ^ane,2

Trials volume 21, Article number:910 (2020) Cite this commodity

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Abstract

Background

Practitioners of complementary and alternative medicine have suggested that electroacupuncture (EA) could amend postal service-stroke cerebral 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 retentivity (WM) and electrophysiology.

Methods

After assessing their eligibility, 66 patients with stroke will be enrolled from 2 Chinese medicine hospitals and randomly divided into theta frequency EA group, gamma frequency EA group, and sham-EA group according to the ratio of one:1:i. All patients volition receive 20 sessions of EA procedures for 4 weeks. Patients in iii groups volition 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), twoscore Hz (gamma-EA group), and no electric current through the electrodes (sham EA). Patients and assessors will be blinded throughout the unabridged study. The primary outcome is the performance accuracy of 1-dorsum chore which is a oft used mensurate of WM in cognitive neuroscience enquiry contexts. Secondary result measures will include the response fourth dimension of one-back chore, the Rivermead Behavioral Retention Test, Trail Making Exam, Loewenstein Occupational Therapy Cognitive Assessment Calibration, modified Barthel Alphabetize, and electroencephalogram (EEG) signals during 1-dorsum tasks. A blinding alphabetize will be assessed. Data will be statistically analyzed by i-way ANOVA, at 5% of significance level.

Discussion

We wait this double-middle, 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 2022.

Peer Review reports

Background

Cognitive dysfunction is i of the mutual dysfunctions in patients after stroke. The decline in cognitive function has a serious impact on patients' quality of life and is a major factor to forestall patients from returning to society [ane, 2]. Working memory (WM), an important part of cognitive function, is considered to be the ground for the brain to successfully perform circuitous behaviors [3]. Studies take shown that the incidence of WM disorders amidst post-stroke patients is equally high every bit 87.6% [4].

As the principal responsibleness for information retentiveness and processing in the brain for a short time [5], WM pass up will cause a decline in overall cerebral function [3, vi]. For example, patients with WM impairment may have difficulty performing daily activities such as memorization, reading, writing, planning, coherent performances, and communication [7, 8]. For post-stroke patients, WM disorder can besides reduce the efficiency of individual rehabilitation training, such as learning and maintaining new movements [9]. In addition, emotional disequilibrium and self-regulation (such as depression) may also occur due to WM deficits [8, 10]. Despite they take a high incidence in stroke patients, WM disorders are often overlooked because they are hidden [4]. Therefore, at that place are still few clinical studies on WM rehabilitation after stroke [11].

Acupuncture, as the main treatment method of traditional Chinese medicine, is commonly used in the clinical treatment of neurological diseases [12,13,14]. The method of executing electrical stimulation on the needle body afterward inserting the needle into the acupoints is called electroacupuncture (EA) [15]. A meta-analysis has shown that acupuncture (including EA) has a positive effect on post-stroke cognitive function [16]. Nevertheless, tin EA improve WM impairment later on stroke? What is the optimal frequency of EA to amend WM? It is truthful that we need more related clinical researches on those questions.

Current neuroscience research has found that neural oscillations play an important role in a range of cerebral function [17,eighteen,nineteen,xx,21]. For example, electroencephalogram (EEG) recording shows that subjects' oscillations in theta (iii–8 Hz) and gamma (> 30 Hz) band have a special correlation with WM [22,23,24,25]. Among them, the oscillations in the theta band are responsible for organizing and arranging WM items in sequence [26]; the oscillations in the gamma band play a function in maintaining WM information [27]. In add-on, many experiments have confirmed that transcranial alternate current stimulation (tACS) at theta and gamma frequencies can enhance WM in healthy subjects [18,xix,20].

Compared with tACS, EA is a more mature and widely used clinical treatment therapy. A big number of studies have confirmed the safe and effectiveness of EA in the treatment of mail-stroke patients. Collectively, this study will explore the effects of EA in the theta (6 Hz) and gamma (xl Hz) bands on WM of stroke patients and investigate changes of electrical activity in the cerebral cortex before and after intervention.

Methods/design

Primary objective and study hypothesis

The primary purpose of this clinical trial is to observe the efficacy of EA at theta, gamma, and sham frequencies on WM. We adopt the archetype evaluation paradigm of WM: using 1-back image to evaluate the operation of all patients earlier and after intervention. Three groups of patients were compared between baseline and later on intervention. Information technology is hypothesized that EA intervention at theta and/or gamma frequencies may significantly improve patients' WM.

Secondary objectives

(i) Since the central executive system is an important function of WM, the study will observe changes in executive functions. (2) WM is closely related to the patient's overall cognitive level and ability to daily life. The study volition also observe patients' behavioral memory, overall cognition level, and daily life ability. (3) Past using EEG, nosotros recorded the electrical signals of the cerebral cortex of patients during 1-back tasks. Through the analysis of the EEG information, the effects of theta-EA and gamma-EA on the electrophysiological properties of the brain volition be investigated and compared with sham EA.

Report pattern

This study is a 2-heart, randomized, sham-controlled, blinded patient and evaluator, parallel clinical trial. Our written report volition show if it is feasible to arrange patients randomly in EA trials of WM later on stroke. The results of the study volition be used to sample size calculation to provide a footing for subsequent inquiry.

Sixty-six mail service-stroke patients will be recruited to participate in the trial. Before the experiment begins, the doctor will provide specific information nigh the trial to patients both orally and in writing. All patients will voluntarily sign an informed consent provided past the attending doctor. The informed consent was approved by the ethics commission before the formal experiment begins. All patients will be screened co-ordinate to eligibility criteria. Threescore-six postal service-stroke patients will exist randomly divided into theta-EA group, gamma-EA grouping, and sham-EA group according to the ratio of ane:1:1. The EA treatment and evaluation did not perform simultaneously. The evaluation will be performed the 24-hour interval before the intervention. The second evaluation is at least 2 h afterwards the last intervention. All patients volition receive an intervention that lasts for 4 weeks (thirty min a day, five days a week, Monday to Friday).

Considering that the focus of this experiment is to explore the effects of EA at unlike frequencies on WM, patients in three groups volition receive EA at two aforementioned acupoints in the head: Baihui (GV20) and Shenting (GV24). The frequency of the 3 groups of EA is selected as follows: 6 Hz (theta-EA), 40 Hz (gamma-EA), and no current through the electrodes (sham EA). The overall schematic diagram and schedule for the study are respectively shown in Figs. ane and ii.

Fig. 1

Flow diagram of the study pattern including the process of recruitment, allocation and intervention, and assessment. EA, electroacupuncture; RBMT, The Rivermead Behavioral Retention Test; TMT, Trail Making Test; LOTCA, Loewenstein Occupational Therapy Cognitive Cess Calibration; MBI, Modified Barthel Index; new BI, new blind index

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Fig. 2

Standard Protocol Items: Reccommendations for Interventional Trials (SPIRIT) figure. EA, electroacupuncture; MMSE, Mini-Mental State Examination; RBMT, The Rivermead Behavioral Retention Test; TMT, Trail Making Examination; LOTCA, Loewenstein Occupational Therapy Cerebral Assessment Scale; MBI, Modified Barthel Index; new, BI new blind index

Full size image

Setting and recruitment

Eligible patients will be recruited past Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine and Anhui Wannan Rehabilitation Hospital. Both hospitals will post research advertisements online (website) and offline (affiche) to recruit patients. To enhance recruitment quality, investigators will monitor medical records. The attending doctor will carefully inquire and record the patients' past and present medical history.

Ethical review and general statements

The study will be conducted in accordance with the enquiry protocol and the electric current version of the Helsinki Declaration. All patients volition be fully informed about the trial and sign a written informed consent form before participating. This trial was approved by the Ethics Committee of Yueyang Integrated Infirmary of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine (approval number: 2022-121), and registered in Cathay Clinical Trial Registration Middle (ChiCTR. gov) in March 2022 (registration number: ChiCTR2000031995).

Eligibility criteria

Inclusion criteria

Eligible patients must meet all of the following criteria before beingness randomized: (a) male person or female between the ages of 18 and 80; (b) diagnosis of cerebral hemorrhage or cerebral infarction by using computed tomography (CT) or magnetic resonance imaging (MRI); (c) got at to the lowest degree 24 points in MMSE test to ensure that the patient has not defenseless dementia; (d) had a stroke more than 1 month before; (e) GDS cocky-rating depression scale ≤ 6 points; (f) can tolerate an evaluation that lasts 2 h; (g) is consciousness and has a stable physical status; and (h) giving exact and written consent that signed and confirmed by the patient.

Exclusion criteria

Patients will be excluded if they meet 1 or more following criteria: (a) has severe visual and hearing issues; (b) has severe impairment in linguistic communication understanding which shown by tests for aphasia screening scales; (c) has local skin infections, ulcers, and scars or is allergic to acupuncture; (d) has astringent bleeding and coagulopathy; (e) trunk or caput metal implants (except oral cavity): implantation of pacemakers, defibrillators, cochlear implants, and drug pumps; (f) skull fractures and/or severe head injury; (grand) get seizures; (h) has mental disorders; (i) severe concrete conditions (such every bit center disease); and (j) other diseases or medical conditions that affect cerebral part.

Randomization and allotment

For randomization, to reduce the take a chance of bias and defoliation and increase the probability of coming together statistical analysis assumptions, a restricted randomization with a random block size between 3 and half-dozen volition be used (the exact size is determined by an external agency) [28]. Two centers volition both receive a computer-generated random list from third-party partners (MATLAB 2022b, Mathworks Inc., Natick, MA, The states) which will non participate in this research. Envelopes with sequential numbers are opaque and sealed and volition be distributed to each test center by a third-party agency that is not part of the research team. Before the first handling and after the treatment is completed, the therapist volition be notified to perform a baseline and mail service-treatment evaluation of the patient.

Blinding

To minimize deviations and disturbances acquired by other factors, the acupuncturist will not give the patient whatever information about the treatment. In this study, the interventions that patients received in three groups will continue equally consequent as possible except for different frequencies. Even needles' position, bending, depth, and acupuncture technique that patients received volition be kept completely consistent. Visually, the sham-EA group looks the same every bit the ii observation groups. The electrodes will be continued to the needle body, and the EA instrument will as well exist turned on and modulated with the parameters. During the three groups of treatments, the EA instrument was placed on the back of the patient to ensure that the patient could non meet the parameters of the stimulation. The specific stimulation scheme of sham EA volition exist introduced in the chapter of false EA. The in a higher place scheme ensures that patients do not know what kind of intervention they are receiving. At the same time, assessors are non involved in the treatment to ensure the completion of the bullheaded method. At the terminate of the study, patients and assessors volition be asked to try to infer which grouping they think they belong to. Judgment results are calculated through new blindness index (BI) [29] to assess the success or failure of blinding. Unblinding should be determined on a case-by-case basis and considered just in a critical medical emergency. If unblinding happen, the subject will be terminated from the trial immediately, and the investigator will record the reason for the termination in the CRF. All data volition be retrieved with the CRF after the trial, and then as to clarify the reason, telescopic, and time of unblinding to evaluate the efficacy and prophylactic of the written report.

Interventions

Patients will be divided equally into theta-EA, gamma-EA, or sham-EA. All groups volition receive conventional neurorehabilitation handling. The trial'due south intervention programme volition be added to the existing treatment plan for 30 min per day for four weeks (Monday to Friday). To ensure adherence to intervention, we volition strengthen the communication betwixt researchers and patients such as researchers will communicate with patients to determine the time betoken for daily intervention to ensure that treatment is received at a fixed time. The monitor committee will control procedures for monitoring adherence that two trial centers are required to track and record specific rehabilitation programs and accurate information such every bit the frequency and dose of medications.

Conventional therapy

All patients will receive basic treatment, including daily rehabilitation and clinical medications. Conventional rehabilitation treatments include physical therapy and occupational therapy. During the intervention, the patient cannot receive other acupuncture treatments or take cerebral drugs. Ii trial centers are required to track and record specific rehabilitation programs and accurate information such as the frequency and dose of medications.

Verum EA stimulation (theta-EA group, gamma-EA group)

Patients will be treated by an experienced acupuncturist with at least 2 years of clinical experience in acupuncture. The acupuncture points selected for treatment are [Baihui (GV20)] and [Shenting (GV24)]. Earlier treatment, the skin at the acupoint volition be disinfected with 75% ethanol. And and then the acupuncturist volition use 1 hand to fix the patients' head and use the other hand to insert the needle into the acupuncture point (Hwato, disposable, 0.35 × forty mm, the distributor is Suzhou Hwato Medical Devices, Suzhou, Mainland china). The insertion angle is about 10–20° (between the needle and the scalp), and the insertion depth of the needle is about 0.three–0.5 cun (ane cun = three.33 cm). After insertion, the acupuncturist will gently twist the needle for 1 min. Subsequently "Deqi"(a feeling of soreness, tingling, or bloating), the electrode will be continued to the needle torso. Then the acupuncturist will set the stimulation parameters: the theta-EA group's stimulation frequency is vi Hz; the gamma-EA group's stimulation frequency is 40hz [19]. The EA device (Hwato, SDZ-III, Suzhou, China) is placed behind the patient to ensure that the patient does not know the specific frequency parameters of the intervention. Patients should receive an intervention concluding for 4 weeks (30 min a mean solar day, 5 days a week, Monday to Friday) [12]. During the intervention, patients are asked to be quiet to minimize other interference factors.

Sham-EA grouping

The acupuncture points and operation procedures of the sham stimulation grouping were consequent with those of the other 2 groups. The but divergence from the other two groups is that the electrode connected to the needle torso is actually in a no-electric current land [xxx]. The details are as follows: (1) in the sham-EA group, a special wire which cannot exist powered was used, although its appearance is not unlike from other ordinary wires; (ii) visually, the sham-EA group looks the aforementioned every bit the two ascertainment groups; (three) the EA device is placed behind the patient to ensure that the patient does not know the specific frequency parameters of the intervention; and (4) when the patient is undergoing intervention, the researcher will accompany the patient to ensure that the patient looks forward and stays still in a quiet state.

Dropout criteria

Patients will be discontinuing interventions if they meet one or more following criteria: (a) mistakes/acceptances (subjects who were mistakenly included); (b) subjects have poor compliance and have not been treated equally prescribed, for example, subjects who cannot cooperate with researchers or subjects who are unable to remain repose and stay still or subjects who cannot come to handling on time; (c) incomplete medical tape data that affects the evaluation of efficacy; (d) subjects withdraw on their own; (e) subjects have adverse events (including recurrence of stroke or cerebral hemorrhage, stuck needles, bent needles, hematoma, pain, and metal allergy); (f) the subject's disease has worsened severely, or some comorbidities, complications, and special physiological changes take occurred (which is unknown agin events that nosotros may encounter during the written report); and (yard) the researcher believes that the bailiwick is non suitable to continue participating in this study.

Outcomes

Primary outcome

Accuracy (d`) scores of visualizing one-back digital tasks

The calculation of d` in 1-dorsum will exist described in detail in the statistics section. The patient will demand to perform a visual ane-dorsum digital task in 5 min. The patient will be asked to respond to stimuli (number shown on screen) as needed. In the 1-back, participants had to base of operations their target/nontarget (i.e., match/non match) decision on the particular digital they saw within the sequence one trial earlier. The patient will exist asked to press j on the keyboard as presently as possible if the numbers are the aforementioned while press f if not. This test includes 200 trials which include 40 target stimuli. Each stimulus will last for 600 ms, and so a blank screen of 1400 ms volition exist used as the stimulus interval [31]. The mission was edited and implemented by E-prime 3 and will be displayed on a 24-in. screen. The numbers are ii cm high in white font with a black groundwork. The distance is 0.8 chiliad and the viewing angle is i.001. The evaluation process is shown in Fig. 3.

Fig. iii

Illustration of 1-back chore

Full size epitome

Secondary event measures

Response time (RT) value of visualizing ane-back digital tasks

The response time ordinarily represents the time for the subject to reply to the stimulus and is closely related to the patient'due south attending. The way that select and assay the RT value (RT-hit) is the about commonly method to evaluate the response.

The Rivermead Behavioral Memory Test (RBMT)

RBMT-Ii is mostly used to evaluate retention recovery in patients with brain injury. The test operation is simple, and the entire test process takes twenty~30 min. Specific assessments include the followin chiliad[32, 33]: (1) Remembering a person'south name. The detection method is to starting time show the subject the associated proper name and face (photo), then, require the subject to say the corresponding name when showing the photograph to him once again (without telling the subject in advance that he needs to complete this test). (2) Remember 10 common items (requires subjects to name and learn) and five faces. The subjects are first shown some objects and faces, and so ask the subjects to identify the objects and faces that they saw initially later mixing these target stimuli with the same amount of interference stimuli. (three) Remember the chief points of a slice of prose, test information technology immediately, and and then test once again after twenty min. (4) Observe five designated points in the room according to the given road, get-go the test immediately, and and then test again subsequently xx min (for patients with reduced mobility, employ a model or a picture to examination). At the same fourth dimension, patients are required to go out a message (envelope) at each point. (v) Remember to ask for their personal items at the terminate of the exam (after 20~30 min). These items were taken by the examiner from the patients at the beginning of the exam. (vi) Remember a special question (schedule your next appointment). At the start of the test, the tester told the patient a special question according to the instructions and then the subject should remember the question when the alarm sounded afterward 20 min. (7) Ten questions are used to detect the patient's orientation to time, place, and person. Some other question is to ask the patient the appointment of the 24-hour interval. Each exam item is divided into the initial points, and the standard points are finally calculated. The score ranges from 0 to 24. A higher score means amend retention function.

Trail Making Examination (TMT)

TMT is a usually used neuropsychological test that evaluates subjects' visual search, scanning, processing speed, thinking flexibility, and executive functions. The trial tracking test consists of two sub-tests: TMT-A and TMT-B. Each sub-examination consists of 25 circles distributed on a slice of paper [34, 35]. In the TMT-A evaluation section, the circles are numbered one–25 and the circles are randomly distributed. Patients should describe lines to connect the numbers in ascending guild. In part B, the circumvolve contains both numbers (1–xiii) and letters (AL); as described in section A, the patient was asked to draw lines connecting circles in ascending order. The divergence from part A is that in office B, the patient is asked to draw lines to connect numbers and messages (i.e., i-A-ii-B-3-C) alternately to complete the task. The examination requires patients to connect the circles every bit shortly as possible. The score for each section represents the fourth dimension required to complete the task. The Chinese version of TMT-B uses numeric symbol encoding.

Loewenstein Occupational Therapy Cognitive Assessment scale (LOTCA)

This scale includes orientation, perception, visual motor organization, and thinking operation. The orientation includes fourth dimension and place; perception includes objects, examination of agnosia, apraxia, etc.; visual move organization includes 2-dimensional graphics and three-dimensional building block copying, puzzles, drawing clocks, etc.; and thinking operations include category testing (that is, nomenclature of particular pictures), ordering of stories, and graphic reasoning [36]. Finally, the patient's attention was scored according to his/her overall performance, and the score was calculated into the full score. The lower the score, the more obvious the dysfunction.

Modified Barthel Alphabetize (MBI)

MBI assesses the impairment of daily activities of patients with neurological disorders and takes the available external back up (specific equipment, etc.) into account [37]. The scale rates motor and cognitive functions on a v-betoken scale (0–4; the higher the score, the less dependent).

EEG recording

When patients perform a one-back task, their EEG signals are also recorded. The EEG signals were recorded with a 64-channel encephalon electrode (Bp) device at a sampling rate of thousand Hz. All electrodes have sintered Ag/AgCl sensors that snap directly into the lid (total peak 3.5 mm). The impedance recorded in the EEG remains below 8 kΩ. The ground electrode (GND) is located at Fz, and the reference electrode (reference) is located at Cz. A vertical center motion (VEOG) electrode is located 2–3 cm from the left eye and serves equally a reference electrode for online recording. Each patient is required to adjust the sitting position during the entire experiment to proceed the whole body muscles, specially the facial muscles relaxed, and try not to motion.

New blind alphabetize

Patient and evaluator blindness will exist assessed separately with the new BI [29]. They will exist asked which grouping they call up they belong to and cull ane of the following answers: verum-EA grouping, sham-EA group, or unknown. The new bullheaded index is scaled to intervals of − 1 to one. Amidst them, 1 means there is no bullheaded method at all, 0 ways completely blind method, and − 1 ways the contrary guess, which may be related to unblinding.

Data collection methods and management

Data volition exist nerveless on Case Study Forms (CRF), which will resemble the paper forms approved by the ideals committee. The information from primary outcome and secondary upshot will be transferred from the output files and assessment forms to the CRF. An identification code will be allocated for each patient during the enrolment phase to preserve anonymity. Only CRF will be immune to record patient identification. Ii data managers will type the CRF into the computer and check the paper and the electronic data. Except for the ethics committees during inspect, all data volition be confidential and made bearding to anyone outside the written report. About EEG data, we will solicit participants to consent that the information will be kept at the hospital for time to come studies. All the information will be available from the corresponding author for utilise and/or assay. During the study, If the participants discontinue or deviate from intervention protocols, nosotros volition collect as much data as possible for further analysis. Plans that promote participant retentiveness and consummate follow-upward are as follows: primarily, we will strengthen the communication between researchers and patients, in order to gain the agreement and cooperation of patients as much equally possible; furthermore, we will give the patients corresponding financial compensation according to the number of times the patients participated, then every bit to encourage the patients to continue participating in the experiment until the end of the experiment; concluding but not least, patients will receive free relevant test results including cognitive assessment, etc. The results of the experiment will be used to write an commodity for clinical enquiry, and the commodity will exist published in a relevant periodical for professional person medical workers and the public to review. The patients will also be informed with the phone number of the attending doctor while undergoing the experiment. Information technology is convenient for them to get more information about the experiment from the attending physician.

Sample size adding

The master endpoint was the difference of accurateness (d`) scores respectively at baseline and endpoint between the three groups (gamma-EA group, theta-EA group, and sham-EA group) in the one-back test for patients with mail service-stroke. Since nosotros did not have plenty previous inquiry as the basis for our estimated sample size, nosotros chose the data collected in the previous pre-experiment to calculate the sample size required for this experiment. The null hypothesis is that μ <sub>i</sub>  =μ <sub>j</sub>  =μ <sub>t</sub> , while the alternative hypothesis is μ <sub>i</sub>  ≠μ <sub>j</sub>  ≠μ <sub>t</sub> , where μ is the hateful difference and i, j, and t denote the sham-EA, gamma-EA, theta-EA grouping, respectively. Our pre-experimental results of 1-back accuracy (d`) scores show that later treatment, the d` values of the gamma-EA group (two.48 ± 0.32) and the theta-EA group (2.02 ± 0.53) are improved compared with the sham-EA grouping (1.88 ± 0.60). Using the sample size calculation formula for comparing the average of multiple contained samples in the parallel design, under the assumptions of α of 0.05 and (1-β) of 0.8, a sample size of xviii per group has been calculated. Considering a 20% dropout rate, a full of 66 patients will exist enrolled in the trial (22 per group). The specific calculation formula is as follows [38]: n = λ/Δ

• $$ \Delta =\frac{ane}{\sigma^ii}\sum \limits_{i=one}^One thousand{\left({\mu}_i-\overline{\mu}\right)}^2\kern0.5em \overline{\mu}=\frac{one}{k}\sum \limits_{j=1}^g{\mu}_j $$

Statistical assay

Baseline comparison

Examine potential baseline differences between the 3 groups. Chi-foursquare test was used to measure gender, education, and pathological characteristics (intracerebral hemorrhage or cerebral infarction). One-style ANOVA was used to analyze pre-intervention assessment results and information such as age. Baseline comparisons were used to detect potential differences between the intervention and sham-EA group, ensuring that in that location were no differences between the three groups.

The efficacy analysis will use an intention-to-treat assay

The results of 1-back evaluation are based on the accuracy and response time as the observation indicators. The evaluation results of RBMT, TMT, LOTCA, and MBI are summarized according to the calculation rules of each scale. The results of each of the higher up assessments are expressed equally mean ± SD. The statistical method uses assay of variance (bold a normal distribution) and using Kruskal-Wallis (non-parametric test) to test if it does non come across the normal distribution. The significance level was 95% (p values alpha < 0.05 on both sides). If the data is missed, the last observation carried frontwards method will exist applied.

Specific adding schemes for the RT value and accuracy of the 1-dorsum paradigm [39]

The RT value in this study is selected for analysis by the RT value (RT-striking), which is the almost common method to evaluate the response. Accurateness is represented by the value of d`. The specific formula is equally follows: d =Z _Hit −Z _FA. Among them, Z _Hit and Z _FA are converted to Z values from the hit rate and false alert rate according to the POZ conversion table. Afterwards calculating the d value and RT value of each subject field, data were imported into SPASS, and one-way ANOVA was used to compare the differences between the three groups earlier and after the intervention.

EEG data

EEG is widely used in neuroscience inquiry [xix]. This study is based on previous EEG studies related to WM [25]. Result-related potentials were selected for assay to explore changes in electrical activity in the cerebral cortex before and after EA intervention at different frequencies. The target components of ERP are N20, P300, and slow-wave NSW. One-way assay of variance was used and non-parametric tests were used when variances were uneven. Results demand to exist Bonferroni corrected.

New BI

Referring to other blind studies, if the calculated confidence interval of the new BI includes null, we will consider the bullheaded method to be successful in this written report.

Currently, we accept not whatever boosted analyses due to smaller sample sizes in each group.

Patient safety

Adverse events attributable to the EA may include discomfort or bruising at the sites of needle insertion, nausea, or feeling faint. And in astringent cases, the needle pain of EA may lead to transient hypertension, inducing recurrence of stroke or cognitive hemorrhage. The method that prevents these adverse events is as follows: (1) Researchers volition maintain adequate advice with the patient earlier the intervention to ensure that the patient will exist in a expert country earlier the intervention, including claret pressure level and emotional stability, non-hungry and enough rest; (ii) During the intervention menses, the researchers will pay shut attention to the patient'south condition. If the patient feels any discomfort, the intervention volition be stopped immediately and the adverse events volition be dealt with accordingly. For example, when dizziness and headache occur, intervention should be stopped and the patient will be asked whether they have other discomforts. At the same fourth dimension, the patient's blood pressure and heartbeat should be measured immediately, and the attention physician volition be notified to diagnose and treat the patient urgently, and if necessary, a respective imaging examination will exist inspected to the patient; (3) later the patient's condition is stable, the researcher will follow up patients to record and analyze the causes of agin events in accordance with the requirements of ethics and clinical trials and discuss prevention plans to reduce the incidence of such agin events equally possible. Whatever medical occurrence after inclusion (not necessarily acquired by the intervention) volition be recorded on the CRF and on a progress protocol. This study volition be sent to the ethics committee as a safety written report. Serious adverse events volition be reported to the ideals committee, coordinating heart, steering committee, and sponsor immediately, and all participating will be informed past the sponsor, which is the Shanghai Municipal Development Office of Traditional Chinese Medicine. Researchers volition effort their best to prevent possible agin events. And if the damage happened, the enquiry squad will provide treatment costs and respective financial compensation for the patient.

Organisation

Members of the coordinating middle include the director, information manager, database developer, statistical analyst, project coordinator, and research assistants. The managing director oversees the scientific aspects of the study design. The information managers are responsible for the drove of data and other information and quality assurance activities. Database programmers are responsible for inbound data into the database. Statistical analysts are responsible for data analysis. The projection coordinators are responsible for study communications, training, and certification of clinical staff in trial procedures. Inquiry assistants are responsible for assisting others. Members of the steering committee include the study chair, data coordinating center director, statistician, and clinical middle directors. The responsibilities of the steering committee include the post-obit: (1) review and blessing of trial procedures, (2) resolution of technical or operational issues, (3) review of study progress and approval of major changes to the study protocol, and (4) oversight of publication of report findings. In this report, the responsibilities of the endpoint adjudication committee are included in the ethics commission and the data management squad is included in the analogous eye. Therefore, there is no independent endpoint adjudication committee and data management team.

Quality command

To ensure the treatments and assessment at a high standard, both the acupuncturist and the assessor have to provide a proven tape of at to the lowest degree 2 years of clinical experience. All clinicians in this study will participate in a three-day training class in the standard operating procedures provided by the author of the protocol. In this training course, the protocol volition be explained and good during exercises and office-plays. The analogous center, independent of the sponsor, will monitor source documents every 3 months. Whether the data is consummate and accurate volition exist adamant by the coordinating center. The regulatory binder which includes the protocol and all revisions of informed consent, case study forms, and the investigator'south agreements volition be also up to engagement by the analogous center.

Discussion

WM disorder is a hidden dysfunction in post-stroke [four]. In traditional rehabilitation training, in that location is no effective rehabilitation plan for working memory [40, 41]. Acupuncture has an verbal effect on the comeback of cognitive function afterwards stroke [42, 43]. Notwithstanding, at that place is no clear evidence on whether EA can improve WM and the pick of frequency is unclear. Therefore, we design a double center in a random, sham comparison and blinded of patient and evaluator, parallel clinical trial to find the effectiveness of theta and gamma EA therapy and sham EA therapy for WM.

Acupuncture points pick

In this study, we chose two acupoints—"Baihui" (GV20) and "Shenting" (GV24), which are situated on the Du acme—for our study. In the TCM theoretical organization of acupuncture, the Du Meridian is the eye of the brain and is closely related to the mind [44]. Baihui (DU xx) and Shenting (DU24) are closely related to brain function and are widely used in the treatment of mental and emotional illnesses [45]. Baihui (DU20) is located at the highest betoken of the head, where all the yang meridians come across. Baihui (GV20) has the functions of clear the listen, lift the spirits, and promote resuscitation in acupuncture [46]. Shenting (DU24) is located on the anterior median line of the head and is likewise an important acupoint for the Du Acme. The efficacy of Shenting (DU24) is similar to Baihui. These 2 acupoints are oftentimes used in combination in clinical exercise [12]. In modern times, many studies using animal models of stroke have revealed that acupuncture at the Baihui (DU20) and Shenting (DU24) acupoints can amend the learning and memory deficits of rats with cerebral ischemia/reperfusion (I/R) injury [47, 48]. Effects of the treatment include the post-obit: (1) alleviate the harm of brain edema caused by cerebral ischemia [49], (two) increment the expression of cell division cycle [50], (3) increment cerebral perfusion of the cerebral cortex [51], and (4) increase the plasticity of neuroblast and enhancing the proliferation of prison cell [52].

Outcome measurements selection

North-back job, as the primary outcome, is one of the traditionally been used paradigms to explore the neural footing of WM and executive function (EC) [53]. Neuropsychological studies show EC (including shifting, updating, and inhibition) is a cadre component of WM [54], unlike other unproblematic storage tasks, such as forwards digital span task [55]; n-back task is regarded as a typical job loading on WM updating [56]. In n-back job, participants need to decide whether the current stimulus is the aforementioned as the stimulus they saw n steps back. The larger the value of n, the higher the difficulty level of the test [57, 58]. In the pre-experiment, we booked 9 patients with cerebral infarction and randomly assigned them to the theta-EA group, gamma-EA group, and sham-EA group. The intervention parameters and course of handling are consequent with this experiment. Before intervention, patients were evaluated 0-dorsum, 1-back, and 2-dorsum. It was found that half dozen subjects had difficulty performing 2-back, so just 0-dorsum and i-back were evaluated later the intervention. The results showed that 0-back has the ceiling effect. Thus, we choose one-back to assess patients' working memory. In improver to dealing with behavioral evaluations, assay of the EEG signals is as well an important aspect. Studies have shown that the different components of ERP are closely related to the information processing process of working retentivity [59]. For instance, N2 is related to the maintenance of information [60], and P3 is related to the updating of data and allocation of attentional resource [61]. Hence, we recorded the task status of the patient'southward EEG signals to explore the impact of the intervention scheme on the electrical activity of the cognitive cortex, including relative to sham.

Limitation

There are some limitations in this protocol. Offset, because there are few clinical studies on working retentivity rehabilitation of patients after stroke, this written report is based on the results of the pre-experiment to calculate the sample size. The sample size of this study is small, which is insufficient to conduct a comprehensive study. 2d, previous acupuncture studies have often used body and scalp acupoints for post-stroke patients with cerebral impairments [62,63,64]. All the same, considering that this study will too notice the event of EA on the electrical activity of the cerebral cortex, nosotros volition only use two scalp acupoints to reduce the interference acquired by as well many acupoints.

Trial status

Ongoing recruitment.

Protocol version number V1, April 2022. Recruitment began on April 2022 and will exist completed by June 2022.

Availability of information and materials

The datasets used and/or analyzed after completing the current report volition be available from the corresponding writer past reasonable requests.

Abbreviations

WM:

Working memory

EA:

Electroacupuncture

MMSE:

Mini-Mental State Examination

RBMT:

The Rivermead Behavioral Memory Test

TMT:

Trail Making Test

LOTCA:

Loewenstein Occupational Therapy Cognitive Assessment Calibration

MBI:

Modified Barthel Index

new BI:

New blind index

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Acknowledgements

Not applicative.

Funding

National Key R&D Program of Red china [Grant No.: 2022YFC2001600,2018YFC2001604].

Shanghai Health Commission accelerated the development of traditional Chinese medicine three-year action plan projection [Grant No.: ZY (2018-2020)-CCCX-2001-06/2004-05].

National Natural Scientific discipline Fund [Grant No.: 81874035].

Intelligent Medical Programme of Shanghai Health Commission [Grant No.: 2022ZHYL0216].

Clinical Science and Technology Innovation Project of Shanghai Shen Kang Hospital Development Heart [Grant No.: SHDC12018126].

These fundings play no part in report pattern, collection, management, analysis, estimation of information, writing of the study, or the decision to submit the written report for publication.

Author data

Author notes

1. Jing-Jing Xu, Meng Ren and Jing-Jun Zhao contributed as to this piece of work.

Affiliations

1. Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, 110 Ganhe Road, Hongkou District, Shanghai, 200000, China

   Jing-Jing Xu, Jia-Jia Wu, Si-Cong Zhang & Chun-Lei Shan

2. Shanghai University of Traditional Chinese Medicine, 1200 Cailun Route, Pudong New District, Shanghai, 200000, Communist china

   Jing-Jing Xu, Meng Ren, Jing-Jun Zhao, Yan-Biao Zhong, Shu-Tian Xu, Zhi-Qing Zhou, Yuan-Li Li & Chun-Lei Shan

3. Anhui Wannan Rehabilitation Infirmary, 3 Zheshang route, Jinghu Commune, Wuhu City, 241000, Anhui Province, China

   Zhong-Yao Cao

Contributions

CLS devised the written report question and design. YLL assists CLS in the study pattern and guides to improve the quality of the manuscript. JJX and MR adult the idea into the total protocol and wrote the article draft. JJZ reviewed the protocol and translation and collation of related materials. STX, YBZ, and ZQZ calculated the sample size and specified the statistical strategy. JJW, SCZ, and ZYC are in charge of enrolling patients and conducting all the procedures. All authors read and approved the last manuscript.

Respective authors

Correspondence to Yuan-Li Li or Chun-Lei Shan.

Ethics declarations

Ethics approval and consent to participate

This study protocol with the written informed consent forms has been peer-reviewed and approved by the Ethics Committee in Yueyang Infirmary of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine (approval No. 2022-121).

All participants will sign an informed consent form at their showtime evaluation visit.

If the protocol is inverse during the research, we will submit it to the ideals commission for review again and the participants will be informed. The change can also be seen on the Chinese Clinical Trial Registry.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Xu, JJ., Ren, Chiliad., Zhao, JJ. et al. Effectiveness of theta and gamma electroacupuncture for mail service-stroke patients on working memory and electrophysiology: study protocol for a double-middle, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial. Trials 21, 910 (2020). https://doi.org/ten.1186/s13063-020-04807-z

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• Received: 21 May 2022

• Accepted: 16 October 2022

• Published: 04 November 2022

• DOI : https://doi.org/10.1186/s13063-020-04807-z

Keywords

• Post-stroke
• Working memory (WM)
• Electroacupuncture (EA)
• Randomized controlled trial

Is The Memory Repair Protocol A Hoax,

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