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检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
脑机接口联合功能性电刺激技术对C5完全性脊髓损伤上肢功能疗效观察
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注册号：

Registration number：

 ChiCTR2400092020 

最近更新日期：

Date of Last Refreshed on：

 2024-11-07 15:41:02 

注册时间：

Date of Registration：

 2024-11-07 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技术对C5完全性脊髓损伤上肢功能疗效观察

Public title：

Brain-computer interface-functional electrical stimulation on the efficacy of upper limb function in patients with spinal cord injury

注册题目简写：

English Acronym：

研究课题的正式科学名称：

脑机接口联合功能性电刺激技术对C5完全性脊髓损伤上肢功能疗效观察

Scientific title：

Brain-computer interface-functional electrical stimulation on the efficacy of upper limb function in patients with spinal cord injury

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：

吴立凡 

研究负责人：

黄富表 

Applicant：

Lifan Wu 

Study leader：

Fubiao Huang 

申请注册联系人电话：

Applicant telephone：

 +86 198 3441 0291

研究负责人电话：

Study leader's
telephone：

+86 135 2271 8130

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：

 wlfsxzyydx@163.com

研究负责人电子邮件：

Study leader's E-mail：

 huangfubiao123@126.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10号院中国康复研究中心

研究负责人通讯地址：

北京市丰台区角门北路10号院中国康复研究中心

Applicant address：

China Rehabilitation Research Center, No.10 Courtyard, Jiaomen North Road, Fengtai District, Beijing

Study leader's address：

China Rehabilitation Research Center, No.10 Courtyard, Jiaomen North Road, Fengtai District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中国康复研究中心

Applicant's institution：

China Rehabilitation Research Center

研究负责人所在单位：

中国康复研究中心

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：

 2023-016-01

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

Name of the ethic committee：

China Rehabilitation Research Center

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-03-02 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 and 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：

中国康复研究中心北京博爱医院

Primary sponsor：

China Rehabilitation Research Center Beijing Boai Hospital

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)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国博爱医院

具体地址：

北京市丰台区角门北路10号

Institution
hospital：

Beijing Boai Hospital

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：

脊髓损伤  

Target disease：

spinal cord injury

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

目前针对SCI上肢功能恢复的康复方法往往基于外周刺激，通过主动或被动的方式增强肌肉力量，促进功能性运动；而脑机接口技术通过促进大脑功能重组可以增强对神经肌肉的控制，与功能性电刺激的结合实现了对SCI患者进行中枢和外周的共同干预，在促进功能改善方面展现出巨大的潜力。本研究对颈段SCI患者进行基于运动想象的脑机接口联合功能性电刺激康复训练，旨在探讨通过促进大脑可塑性改善颈段SCI患者的上肢功能及生活独立性，为颈段SCI患者上肢功能的康复提供新的治疗思路。  

Objectives of Study：

At present, rehabilitation methods for upper limb function recovery in SCI are often based on peripheral stimulation, which enhances muscle strength and promotes functional movement through active or passive means; Brain computer interface technology can enhance control over neuromuscular systems by promoting brain functional reorganization, and its combination with functional electrical stimulation enables joint intervention of central and peripheral nervous system in SCI patients, demonstrating enormous potential in promoting functional improvement. This study conducted brain computer interface combined with functional electrical stimulation rehabilitation training based on motor imagery for cervical SCI patients, aiming to explore the improvement of upper limb function and life independence in cervical SCI patients by promoting brain plasticity, and provide new treatment ideas for the rehabilitation of upper limb function in cervical SCI patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1:听力障碍，不能进行沟通交流；极度躁动不安或有中重度认知障碍不能进行配合； 2:正在使用影响中枢神经系统的药物或接受其他神经调控治疗； 3:视力缺损、单侧忽略等不能看清电脑屏幕； 4：严重的并发症、心肺疾病、不能控制的高血压、严重的身体畸形、多脏器损伤或重要脏器功能不全、严重的痉挛等； 5：颅脑外伤，颅脑术后伤口恢复期患者，无法安放电极或可能因脑电极安放造成感染者；颅骨缺损或用金属材质行颅骨修补术者；内体有金属如心脏起搏器等； 6：上肢或手部骨折未痊愈患者； 7：不愿签署知情同意书者。

Exclusion criteria：

1: Hearing impairment, unable to communicate; extreme restlessness or moderate to severe cognitive impairment 2: Hearing impairment, unable to communicate; extreme restlessness or moderate to severe cognitive impairment 3: Visual defect, unilateral neglect and so on can not see the computer screen 4: Serious complications, cardiopulmonary diseases, uncontrollable hypertension, serious body deformity, multiple organ damage or important organ insufficiency, serious spasm, etc 5: Patients with brain trauma, wound recovery period after craniocerebral surgery, unable to place electrodes or may be caused by brain electrode placement; skull defect or metal skull repair; metal such as cardiac pacemaker in the inner body; 6: Patients without healed upper limb or hand fractures 7: Unwilling to sign the informed consent form

研究实施时间：

Study execute time：

从 From 2024-11-20 00:00:00至 To 2025-05-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-11-30 00:00:00 至 To 2025-04-30 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 15

Group：

control group

Sample size：

干预措施：

对照组进行功能性电刺激的治疗，物理治疗:由专业物理治疗师根据患者具体情况进行肢体被动活动训练、辅助训练或抗阻训练，站立床或站立架训练，下肢被动康复踏车训练，床上移动训练，坐位平衡训练以及呼吸训练。每天60min，每周5d。作业治疗：由专业作业治疗师根据患者功能状况进行良肢位摆放指导，有目的的上肢作业活动训练（与推拉、够取等相关的作业项目），选择合适的辅助具（如万能袖带）进行模拟进食训练、穿衣训练、床椅转移训练等日常生活动作模拟训练。每天30min，每周5d。

干预措施代码：

Intervention：

The control group underwent the treatment of functional electrical stimulation, physical therapy: professional physical therapists performed passive activity training, auxiliary training or resistance training, according to the specific situation of the patient, standing bed or standing stand training, lower limb passive rehabilitation treadmill training, bed movement training, sitting balance training and breathing training. For 60min daily, 5d per week. Operation treatment: by professional homework therapist according to the functional condition of good limb put guidance, purposeful upper limb activity training (with push and pull, enough related project), choose a suitable AIDS (such as universal cuff) simulated eating training, dressing training, bed chair transfer training daily life action simulation training. For 30min daily, 5d per week.

Intervention code：

组别：

试验组

样本量：

 15

Group：

experimental group

Sample size：

干预措施：

实验组进行脑机接口-功能性电刺激系统的治疗，物理治疗:由专业物理治疗师根据患者具体情况进行肢体被动活动训练、辅助训练或抗阻训练，站立床或站立架训练，下肢被动康复踏车训练，床上移动训练，坐位平衡训练以及呼吸训练。每天60min，每周5d。作业治疗：由专业作业治疗师根据患者功能状况进行良肢位摆放指导，有目的的上肢作业活动训练（与推拉、够取等相关的作业项目），选择合适的辅助具（如万能袖带）进行模拟进食训练、穿衣训练、床椅转移训练等日常生活动作模拟训练。每天30min，每周5d。

干预措施代码：

Intervention：

Experimental group of brain-computer interface-functional electrical stimulation system treatment, physical therapy: by professional physical therapist according to the specific patient physical passive activity training, auxiliary training or resistance training, standing bed or standing training, lower limb passive rehabilitation treadmill training, the bed mobile training, sitting balance training and breathing training. For 60min daily, 5d per week. Operation treatment: by professional homework therapist according to the functional condition of good limb put guidance, purposeful upper limb activity training (with push and pull, enough related project), choose a suitable AIDS (such as universal cuff) simulated eating training, dressing training, bed chair transfer training daily life action simulation training. For 30min daily, 5d per week.

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)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 北京博爱医院 

单位级别：

 三甲 

Institution
hospital：

Beijing Boai Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

肌骨超声

指标类型：

次要指标

Outcome：

Muscle bone ultrasound

Type：

Secondary indicator

测量时间点：

干预前后以及随访

测量方法：

使用肌骨超声测量桡侧腕长伸肌和指伸肌肌肉厚度及横截面积。通过可视化肌肉结构，使肌肉厚度和横截面积客观化，能够有效评估治疗前后肌纤维的变化。

Measure time point of outcome：

Before and after the intervention as well as at the follow-up visit

Measure method：

Muscle thickness and cross-sectional area of the extensor and extensor muscles were measured using skeletal ultrasound. By visualizing muscle structure and objectified muscle thickness and cross-sectional area, muscle fibers before and after treatment.

指标中文名：

肌张力测试仪

指标类型：

次要指标

Outcome：

Muscle tone tester

Type：

Secondary indicator

测量时间点：

干预前后以及随访

测量方法：

在肌肉静息状态和收缩状态下测量和记录肌张力的专用仪器，用来测量桡侧腕伸肌的肌张力。仪器主要组成包括：测量手柄、计算机主机、MTIMS软件。当测量手柄探头置于被测肌肉的皮肤上与所测肌肉长轴成互为垂直角度向下按压时，肌肉产生形变。而此形变过程发生的力-位移关系可以量化评价该部位的肌肉张力。

Measure time point of outcome：

Before and after the intervention as well as at the follow-up visit

Measure method：

A dedicated instrument for measuring and recording muscle tone in the resting and contraction states of the muscle to measure muscle tone in the radial extensor carpi. The main components of the instrument include: measuring handle, computer host, MTIMS software. When the measuring handle probe is placed on the skin of the measured muscle and the measured muscle, the muscle is deformed. The force-displacement relationship of this deformation process can quantify and evaluate the muscle tension i

指标中文名：

关节活动度

指标类型：

次要指标

Outcome：

protractor

Type：

Secondary indicator

测量时间点：

干预前后以及随访

测量方法：

采用量角器测量治疗前后患者腕关节背伸和背屈的关节活动度。

Measure time point of outcome：

Before and after the intervention as well as at the follow-up visit

Measure method：

A protractor was used to measure joint mobility in dorextension and dorsiflexion of the wrist before and after treatment.

指标中文名：

功能性近红外光检测

指标类型：

主要指标

Outcome：

Functional near-infrared spectroscopy

Type：

Primary indicator

测量时间点：

干预前后以及随访

测量方法：

通过光谱测定氧血红蛋白和脱氧血红蛋白来监测大脑中血氧的变化，并定量描述组织中的光传输以研究参与大脑活动的神经机制。

Measure time point of outcome：

Before and after the intervention as well as at the follow-up visit

Measure method：

Changes in blood oxygen in the brain were monitored by spectroscopic determination of oxyhemoglobin and deoxyhemoglobin and quantitatively described light transmission in tissues to study the neural mechanisms involved in brain activity.

指标中文名：

GRASSP评分量表

指标类型：

主要指标

Outcome：

GRASSP Scale scale

Type：

Primary indicator

测量时间点：

干预前后以及随访

测量方法：

GRASSP 包含5个子测试并分别测量每个上肢：徒手肌肉测试(MMT):对两侧的手臂和手部的十块肌肉进行了评估。每个项目（肌肉）的评分在0到5之间，其中5分代表正常力量，0分代表完全瘫痪。双方的总分是所有项目得分的总和，最高为100。 Semmes Weinstein（SWM）单丝测量:每只手的3个背部和3个手掌位置有4个探针（单丝）。施加的压力和引起的感觉由从0（无反应）到4（正常感觉）的数值表示。背部或手掌侧的三个位置相加为两侧的子测试总分，范围从0到24分。 定性掌握（QlG）:根据GRASSP手册中概述并由GRASSP国际研究和设计团队开发的抓握采集评估了三个抓握。抓握得分在0（抓握时手腕和手指没有自主控制）和4（产生抓握时手腕和手指的正常自主控制）之间。双上肢抓握质量分测验得分之和为0至24分。 定量抓取（QtG）:根据索勒曼手功能测试，以严格标准化的方式，对每只手臂分别执行6项抓握任务，例如从桌子上拿起钥匙。每项任务根据所用的抓握方式按0到5分进行评分。总分是双方所有任务分数的总和，范围为0到60分。

Measure time point of outcome：

Before and after the intervention as well as at the follow-up visit

Measure method：

GRASSP Contains 5 subtests and measure each upper limb separately:Freehand muscle test (MMT): Ten muscles of the arms and the hand were evaluated. Each item (muscle) is scored between 0 and 5, with 5 representing normal force and 0 representing complete paralysis. The total score for both sides is the sum of all items scored, with a maximum of 100. Semmes Weinstein (SWM) Monofilament measurement: 4 probes (monofilaments) at the 3 back and 3 palm positions of each hand. The applied pressure and i

指标中文名：

脊髓损伤独立性评估量表

指标类型：

次要指标

Outcome：

Spinal cord injury independence assessment scale

Type：

Secondary indicator

测量时间点：

干预前后以及随访

测量方法：

评定内容为17项个体日常生活活动，按功能分为自我照顾、呼吸和括约肌控制、移动能力3大部分。自理部分包括进食、洗澡、穿衣、梳洗；呼吸及括约肌控制部分包括呼吸、膀胱管理、直肠管理、厕所使用；转移部分分为卧室和厕所内的转移以及室内和室外活动两部分，各项评定依据患者自理程度及是否借助辅助具及他人的帮助进行评分分值分别为：0～20、0～40和0～40分，总分为0～100 分；

Measure time point of outcome：

Before and after the intervention as well as at the follow-up visit

Measure method：

The evaluation content included 17 individual activities of daily living, which were divided into self-care, breathing and sphincter control, and mobility. The self-care part includes eating, bathing, dressing, dressing; breathing and sphincter control part includes breathing, breathing, bladder management, rectum management, toilet use; the transfer part is divided into the transfer in bedroom and toilet, indoor and outdoor activities, the self-care of patients and whether the help of AIDS and

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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）：

由一位不参与评估和筛选的治疗师采用随机数字表法分为两组，单数为试验组，双数为对照组

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

A therapist who did not participate in the evaluation and screening was divided into two groups by a random number table, namely, the trial 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（对受试者隐藏分组)，对评估者隐藏分组

Blinding：

Single-blind (hidden group for subjects) and hidden group for assessors

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

是Yes

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）：

原始数据需要与研究者联系

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

The original data needs to be contacted with the researcher

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：

人工采集与管理

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

Manual collection and management

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：

  2024-11-07 15:40:56
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