ChiCTR2500102876 版本V1.0 版本创建时间2025/05/21 10:46:30 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500102876 

最近更新日期：

Date of Last Refreshed on：

 2025-05-21 10:46:02 

注册时间：

Date of Registration：

 2025-05-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

脑机接口联合功能性电刺激对右侧大脑损伤患者上肢功能及大脑激活的研究

Public title：

Research on the Upper Limb Function and Brain Activation of Patients with Right Brain Injury by Brain-Computer Interface Combined with Functional Electrical Stimulation

注册题目简写：

BCI-FES对右侧脑损伤患者上肢功能及大脑激活的研究

English Acronym：

Study on the Upper Limb Function and Brain Activation of Patients with Right Brain Injury by BCI-FES

研究课题的正式科学名称：

脑机接口联合功能性电刺激对右侧大脑损伤患者上肢功能及大脑激活的研究

Scientific title：

Research on the Upper Limb Function and Brain Activation of Patients with Right Brain Injury by Brain-Computer Interface Combined with Functional Electrical Stimulation

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

刘静娅 

研究负责人：

刘静娅 

Applicant：

Jingya Liu 

Study leader：

Jingya Liu 

申请注册联系人电话：

Applicant telephone：

 +86 158 0153 0159

研究负责人电话：

Study leader's
telephone：

+86 158 0153 0159

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 jealousy313@163.com

研究负责人电子邮件：

Study leader's E-mail：

 jealousy313@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市丰台区角门北路18号

研究负责人通讯地址：

北京市丰台区角门北路18号

Applicant address：

No. 18, Jiaomen North Road, Fengtai District, Beijing

Study leader's address：

No. 18, Jiaomen North Road, Fengtai District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

 100068

研究负责人邮政编码：

Study leader's postcode：

 100068

申请人所在单位：

北京博爱医院

Applicant's institution：

China Rehabilitation Research Center

研究负责人所在单位：

北京博爱医院

Affiliation of the Leader：

China Rehabilitation Research Center

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2025-021-02

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中国康复研究中心医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of China Rehabilitation Research Center

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-21 00:00:00

伦理委员会联系人：

孟丽君，何照楠

Contact Name of the ethic committee：

Lijun Meng\Zhaonan He

伦理委员会联系地址：

北京市丰台区角门北路18号

Contact Address of the ethic committee：

No. 18, Jiaomen North Road, Fengtai District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 8702 0512

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中国康复研究中心

Primary sponsor：

China Rehabilitation Research Center

研究实施负责（组长）单位地址：

北京市丰台区角门北路10号

Primary sponsor's address：

No. 10, Jiaomen North Road, Fengtai District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

丰台区

Country：

China

Province：

Beijing Municipality

City：

Fengtai District

单位(医院)：

中国康复研究中心

具体地址：

北京市丰台区角门北路10号

Institution
hospital：

China Rehabilitation Research Center

Address：

No. 10, Jiaomen North Road, Fengtai District, Beijing

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

脑卒中  

Target disease：

cerebral stroke

研究疾病代码：

163

Target disease code：

163

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究聚焦于右侧大脑损伤患者的上肢功能恢复，旨在探索脑机接口（Brain Computer Interface，BCI）联合功能性电刺激（functional electrical stimulation,FES）的治疗效果及其对大脑激活模式的影响。本研究旨在探究BCI-FES在促进右侧大脑损伤患者上肢功能恢复及大脑激活方面的有效性。  

Objectives of Study：

This study focuses on the recovery of upper limb function in patients with right Brain injury, aiming to explore the Brain Computer Interface. The therapeutic effect of BCI combined with functional electrical stimulation (FES) and its influence on brain activation patterns. This study aims to explore the effectiveness of BCI-FES in promoting the recovery of upper limb function and brain activation in patients with right brain injury.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

（1）符合2019年中华医学会神经病学分会和中华医学会神经病学分会脑血管病学组共同识制订的脑卒中诊断标准，同时经过头部CT或MRI等影像学检查确诊为脑梗死或脑出血，并为首次发病，病程≤1个月 （2）左侧偏瘫患者，患侧上肢及手部中、重度功能障碍（Brumnstrom分期1期和2期）。 （3）简易智力状态检查量表(MMSE)＞21分 （4）患者或家属清楚并了解本次研究内容、可能存在的风险及相关风险处理，自愿参加的同时并签署知情同意书。 （5）运动意向问卷评估受试者具有执行心理意象的能力。

Inclusion criteria

(1) It conforms to the cerebral blood of the Neurology Branch of the Chinese Medical Association and the Neurology Branch of the Chinese Medical Association in 2019 The diagnostic criteria for stroke were jointly formulated by the epidemiology group. At the same time, it was confirmed as cerebral infarction or cerebral hemorrhage through imaging examinations such as head CT or MRI, and it was the first onset with a disease course of no more than one month; (2) Patients with left hemiplegia have moderate to severe functional disorders in the affected upper limb and hand (Brumnstrom stage 1 and 2). (3) Mini-Mental State Examination (MMSE) > 21 points; (4) Patients or their families are clear about and understand the content of this study, possible risks and related risk handling, and voluntarily participate while signing the informed consent form. (5) The exercise intention questionnaire assesses the subjects' ability to execute mental images.

排除标准：

（1）存在痴呆:简易精神智能状态量表(MMSE)评分:文盲≤17 分，严重听力障碍、视力障碍、失语等难以完成训练者； （2）存在单侧忽略的患者； （3）存在患侧上肢骨折、严重关节炎、关节置换术等影响上肢运动功能的肌肉、骨骼及其它神经性疾病； （4）有其他原因导致认知障碍的明确病史，如阿尔茨海默病、帕金森病等； （5）与电极片接触部位皮肤损伤、感染或对电极片过敏者； （6）颅内有金属植入物、金属起搏器或颅骨不完整者。

Exclusion criteria：

(1) Present with dementia: Mini-Mental State Examination (MMSE) score: Illiteracy <=17 points, severe hearing impairment, visual impairment, aphasia, etc., making it difficult to complete the training; (2) Patients with unilateral neglect; (3) Muscle, bone, and other neurological diseases that affect upper limb movement function, such as upper limb fractures, severe arthritis, and joint replacement surgery on the affected side; (4) There is a clear medical history of other causes of cognitive impairment, such as Alzheimer's disease, Parkinson's disease, etc. (5) Those with skin damage, infection or allergy to the electrode sheet at the contact site; (6) Those with metal implants, metal pacemakers or incomplete skulls in the brain.

研究实施时间：

Study execute time：

从 From 2025-06-01 00:00:00至 To 2026-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-01 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组（BCI-FES）

样本量：

 17

Group：

Test Group (BCI-FES)

Sample size：

干预措施：

试验组（BCI-FES）：给患者戴上电极帽，首次的患者先测试患者的想象阈值和耐受的功能性电刺激强度，正式进行试验时让患者进行想象，将电极位置：放置在患侧的指总伸肌和桡侧腕长伸肌，想象成功则诱发功能性电刺激产生电刺激。

干预措施代码：

Intervention：

Experimental Group (BCI-FES) : The patients were given electrode caps. For the first patients, the imagination threshold and the tolerated intensity of functional electrical stimulation were tested first. When the trial was officially conducted, the patients were asked to imagine. The electrode positions were: placed on the total extensor of the finger on the affected side and the long extensor of the wrist on the radial side. If the imagination was successful, the functional electrical stimulation was induced to generate electrical stimulation.

Intervention code：

组别：

对照组（FES）

样本量：

 17

Group：

Control Group (FES)

Sample size：

干预措施：

对照组（FES）：根据患者耐受程度进行功能性电刺激。电极位置:患侧的指总伸肌和桡侧腕长伸肌肌腹。

干预措施代码：

Intervention：

Control group (FES) : Functional electrical stimulation was performed based on the tolerance level of the patients. Electrode location: The muscle belly of the total extensor phalanx and the long extensor carpal radialis on the affected side.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

 丰台区 

Country：

China

Province：

Beijing

City：

Fengtai

单位(医院)：

 中国康复研究中心 

单位级别：

 三甲 

Institution
hospital：

China Rehabilitation Research Center

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Fugl-Meyer上肢运动功能评定量表

指标类型：

主要指标

Outcome：

Fugl-Meyer Upper Limb Motor Function Assessment Scale

Type：

Primary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

上肢动作研究量表

指标类型：

主要指标

Outcome：

Action ResearchArm Test, ARAT

Type：

Primary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

改良Ashworth 评定量表

指标类型：

次要指标

Outcome：

modified Ashworth scale

Type：

Secondary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

近红外脑功能成像技术

指标类型：

次要指标

Outcome：

Functional near-infrared spectroscopy

Type：

Secondary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

感觉评估

指标类型：

次要指标

Outcome：

Sensory evaluation

Type：

Secondary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

指标中文名：

改良 Barthel 指数评定

指标类型：

主要指标

Outcome：

modified Barthel index, MBI

Type：

Primary indicator

测量时间点：

试验开始前、四周试验结束后、四周后随访

测量方法：

Measure time point of outcome：

Follow-up was conducted before the start of the trial, after the end of the four-week trial, and after four weeks

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

None

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

主要研究者利用统计软件 SPSS 生成指定数量的随机数，随机将受试者分为试验组和对照组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The principal researcher used the statistical software SPSS to generate a specified number of random numbers and randomly divided the subjects into the experimental group and the control group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

单盲试验。试验主要对研究者进行设盲，由于研究者不知道受试者的具体情况，他们在收集数据和评估时能够保持中立态度，减少数据收集过程中的偏倚和误差。

Blinding：

Single-blind trial. The experiment mainly blinds the researchers. Since the researchers do not know the specific circumstances of the subjects, they can maintain a neutral attitude when collecting data and conducting evaluations, reducing bias and errors in the data collection process.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

数据采集 （1）患者基本信息：包括年龄、性别、损伤类型（如脑卒中、脑外伤）、损伤部位（右侧大脑）、病程时间、既往治疗史等。 上肢功能评估数据：使用标准化的评估工具（如Fugl-Meyer上肢运动功能评定量表、改良Ashworth痉挛量表等）对患者的上肢运动功能、肌力、肌张力等进行量化评估。 （2）脑机接口（BCI）数据：记录BCI系统采集的脑电图（EEG）信号，包括信号的频率、波幅、脑区分布等，以及基于EEG信号解码的运动意图数据。 （3）功能性电刺激（FES）数据：记录FES的参数设置（如刺激强度、频率、脉冲宽度、刺激时长等），以及患者对FES的耐受性和反应。 （4）大脑激活数据：通过功能性磁共振成像（fMRI）或近红外光谱成像（fNIRS）技术，记录患者在执行特定任务时大脑皮层的血流变化或氧合血红蛋白浓度变化，以评估大脑激活情况。 数据管理 （1） 数据录入：将采集到的临床评估数据手动录入到电子数据库中。对于设备采集的数据（如BCI、FES、fMRI、fNIRS数据），直接从设备导出为电子文件，并按照预设的格式和命名规则进行存储。 （2）数据清洗：对录入的数据进行检查，去除重复数据、纠正错误数据、填补缺失数据等。对于设备采集的数据，检查信号的质量，去除噪声干扰和伪迹。 （3）质量控制：建立数据质量控制体系，定期对数据进行审核和验证。确保数据采集过程符合研究方案和操作规范，数据记录准确无误。对于异常数据，进行详细记录和分析，必要时进行重新采集。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection (1) Basic information of the patient: including age, gender, type of injury (such as stroke, brain trauma), location of injury (right brain), duration of disease, previous treatment history, etc. Upper limb function assessment data: Standardized assessment tools (such as the Fugl-Meyer Upper Limb Motor Function Assessment Scale, modified Ashworth Spasticity Scale, etc.) were used to quantitatively assess the upper limb motor function, muscle strength, muscle tone, etc. of the patients. (2) Brain-Computer Interface (BCI) data: Record the electroencephalogram (EEG) signals collected by the BCI system, including the frequency, amplitude, and distribution of brain regions of the signals, as well as the motor intention data based on EEG signal decoding. (3) Functional electrical stimulation (FES) data: Record the parameter Settings of FES (such as stimulation intensity, frequency, pulse width, stimulation duration, etc.), as well as the patient's tolerance and response to FES. (4) Brain activation data: Functional magnetic resonance imaging (fMRI) or near-infrared spectroscopy (fNIRS) techniques are used to record changes in blood flow in the cerebral cortex or oxygenated hemoglobin concentration when patients perform specific tasks, in order to assess brain activation. Data management (1) Data entry: Manually enter the collected clinical assessment data into the electronic database. For the data collected by the device (such as BCI, FES, fMRI, and fNIRS data), they are directly exported from the device as electronic files and stored in accordance with the preset format and naming rules. (2) Data cleaning: Check the entered data to remove duplicate data, correct incorrect data, and fill in missing data, etc. For the data collected by the equipment, check the quality of the signal, remove noise interference and artifacts. (3) Quality Control: Establish a data quality control system and regularly review and verify the data. Ensure that the data collection process complies with the research plan and operation norms, and that the data records are accurate and error-free. For abnormal data, detailed records and analyses should be made, and re-collection should be carried out when necessary.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-05-21 10:46:02