中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR-OOC-17011682
最近更新日期： Date of Last Refreshed on：	2017-06-17 18:56:04
注册时间： Date of Registration：	2017-06-17 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	脑深部电刺激丘脑底核治疗帕金森病的单中心、前瞻性、观察性注册登记研究
Public title：	Subthalamic nucleus deep brain stimulation for Parkinson's disease: a single-centered, prospective, observational registry study
注册题目简写：
English Acronym：
研究课题的正式科学名称：	脑深部电刺激丘脑底核治疗帕金森病的单中心、前瞻性、观察性注册登记研究
Scientific title：	Subthalamic nucleus deep brain stimulation for Parkinson's disease: a single-centered, prospective, observational registry study
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：	马羽	研究负责人：	马羽
Applicant：	Ma Yu	Study leader：	Ma Yu
申请注册联系人电话： Applicant telephone：	+86 13501085569	研究负责人电话： Study leader's telephone：	+86 13501085569
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：	lymayu@163.com	研究负责人电子邮件： Study leader's E-mail：	lymayu@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：	北京石景山区石景山路5号清华大学玉泉医院	研究负责人通讯地址：	北京石景山区石景山路5号清华大学玉泉医院
Applicant address：	Yuquan Hospital of Tsinghua University, 5 Shijingshan Road, Beijing, Shijingshan District, China	Study leader's address：	Yuquan Hospital of Tsinghua University, 5 Shijingshan Road, Beijing, Shijingshan District, China
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：	清华大学玉泉医院
Applicant's institution：	Yuquan Hospital of Tsinghua University
研究负责人所在单位：	清华大学玉泉医院
Affiliation of the Leader：	Yuquan Hospital of Tsinghua University

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：	YQ20170005	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：	清华大学玉泉医院伦理委员会
Name of the ethic committee：	IRB of Tsinghua University Yuquan Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2017-06-07 00:00:00
伦理委员会联系人：
Contact Name of the ethic committee：
伦理委员会联系地址：
Contact Address of the ethic committee：
伦理委员会联系人电话： Contact phone of the ethic committee：		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：

清华大学玉泉医院

Primary sponsor：

Yuquan Hospital of Tsinghua University

研究实施负责（组长）单位地址：

北京石景山区石景山路5号

Primary sponsor's address：

5 Shijingshan Road, Beijing, Shijingshan District, China

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(区县)：	石景山区
Country：	China	Province：	Beijing	City：
单位(医院)：	清华大学玉泉医院	具体地址：	北京石景山区石景山路5号清华大学玉泉医院
Institution hospital：	Yuquan Hospital of Tsinghua University	Address：	Yuquan Hospital of Tsinghua University, 5 Shijingshan Road, Beijing, Shijingshan District, China

经费或物资来源：

自筹经费

Source(s) of funding：

self-financing

研究疾病：

帕金森病

Target disease：

Parkinson's disease

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

评价双侧STN-DBS治疗帕金森病的疗效

Objectives of Study：

To assess the surgical results of bilateral STN-DBS in patients with PD.

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

1. Aged 18 to 75 years old male or female;
2. signed informed consent form;
3. primary Parkinsons disease based on the diagnostic criteria of the UK Parkinsons Disease Society Brain Bank for primary Parkinsons disease or the Chinese criteria for Parkinsons disease with a disease course of ≥ 5 years;
4. the efficacy of levodopa has significantly decreased, and motor function fluctuates or motor dysfunction is presented, which reduces the quality of life;
5. adequate dosages of the optimal medications (i.e., levodopa) have been received;
6. Parkinsons disease severity is at Hoehn-Yahr Stage 2.5-4 when medications are not being taken;
7. good compliance, i.e., patients and their families are willing to be enrolled in the clinical trial for bilateral neurostimulation implantation, receive follow-up regularly, can accurately complete the subjects diary during wakefulness, and the family, custodian, or caretaker can help the subject;
8. improvement after L-dopa stimulation test is no less than 30%;
9. off period is more than 4 hours per day.

排除标准：

1) 帕金森综合症和帕金森叠加综合症。 2）有严重认知障碍(MMSE评分：文盲< 17，小学< 20，初中以上< 24）因痴呆影响受试者的依从性差、不能准确记录日记、和/或不能签署知情同 3）有严重精神病病史者。 4）有难治性癫痫病史（即癫痫发作）。 5）有严重心脏、肝、肾疾病、严重高血压及体位性低血压患者。 6）有严重糖尿病患者或糖尿病伴脑心管病患者。 7）确诊的恶性肿瘤患者。 8）有手术禁忌症（如植入过人工耳蜗、心脏起搏器、心脏除颤器、立体定向神经核团毁损术、曾经植入过单侧或双侧同类产品等）或半年内做过研究者认为对本试验有影响的其他外科手术者，或其他神经外科手术禁忌症。 9）曾经遭受过颅脑神经系统损伤者。 10）正在服用抗凝血药物或有临床出血倾向者。 1 1）妊娠或准备妊娠的妇女。 12）严重的酒精依赖和药物滥用。 13）术前30天内接受了电休克治疗。 14）受试者正在参加其它临床试验，或在三个月内接受了其它临床研究。 15）研究者认为不适宜参加本项临床研究者。

Exclusion criteria：

1. patients with Parkinsonism and Parkinsonism-plus syndrome;
2. patients who have severe cognitive impairment (MMSE score: illiteracy <17, elementary school <20, junior high school or above <24) due to dementia, the compliance of the subject is poor, the subject cannot accurately record in a diary, and/or cannot sign the informed consent form;
3. patients who have a history of severe psychiatric disease;
4. patients who have a history of refractory epilepsy (i.e., epileptic seizures);
5. patients who have serious heart, liver, or kidney diseases, severe hypertension, and orthostatic hypotension;
6. patients who have severe diabetes or diabetes accompanied with brain and cardiovascular diseases;
7. patients diagnosed with cancer;
8. patients who have contraindications to surgery (such as cochlear implants, pacemakers, cardiac defibrillators, stereotactic nucleus ablation, or unilateral or bilateral implantation of similar products), patients who have been enrolled in a study within 6 months and have received other surgeries that could affect the trial, or patients with other contraindications to neurosurgery;
9. patients who have had brain injuries;
10. patients who are taking anticoagulants or have a tendency of bleeding;
11. women who are pregnant or planning to become pregnant;
12. patients with severe alcohol dependence and drug abuse;
13. patients who received electric shock treatment within 30 days before the neurostimulation surgery;
14. subjects who are participating in other clinical trials, or who participated in other clinical trials within a month;
15. patients who are deemed inappropriate for the clinical trial by the researcher.

研究实施时间：

Study execute time：

从 From 2017-06-15 00:00:00至 To 2020-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2017-06-15 00:00:00 至 To 2018-06-30 00:00:00

干预措施：

Interventions：

组别：	Case series	样本量：	100
Group：	Case series	Sample size：	100
干预措施：	丘脑底核脑深部电刺激	干预措施代码：
Intervention：	STN DBS	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(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	清华大学玉泉医院	单位级别：	二级医院
Institution hospital：	Yuquan Hospital of Tsinghua University	Level of the institution：	Secondary A hospital

测量指标：

Outcomes：

指标中文名：	UPDRS评分	指标类型：	主要指标
Outcome：	Change in parkinson's disease symptoms as determined by UPDRS scores during the study as compared with baseline	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	帕金森病患者生活质量量表评分	指标类型：	次要指标
Outcome：	Change in PDQ-39	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	左旋多巴等效剂量	指标类型：	次要指标
Outcome：	Change in medication usage during the study as compared with baseline	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	NA	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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	75	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）：

NA

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

NA

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：	NA
Blinding：	NA
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	清华大学玉泉医院神经外科
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Neurosurgery Department, Yuquan Hospital of Tsinghua University
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：	（1）病案资料由HIS系统保存（2）图像资料以DVD形式保存（3）研究数据以EXCEL数据库保存
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	(1)patients data were preserved by HIS (2)image data were prserved by DVD (3)research data were preserved by EXCEL data base
数据与安全监察委员会： Data and Safety Monitoring Committee：
注册人： Name of Registration：	2017-06-17 18:56:04