ChiCTR2200066452 版本V1.1 版本创建时间2023/05/06 15:04:04 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：

 ChiCTR2200066452 

最近更新日期：

Date of Last Refreshed on：

 2022-12-06 10:48:11 

注册时间：

Date of Registration：

 2022-12-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

数字疗法应用于注意缺陷多动障碍（ADHD）、抽动障碍（TD）以及抽动障碍（TD）共患注意缺陷多动障碍（ADHD）儿童的前瞻性、基线对照临床试验方案

Public title：

Prospective, Baseline Controlled Clinical Trial Protocol of Digital Therapy in Attention Deficit Hyperactivity Disorder (ADHD), Tic Disorder (TD), and Children with ADHD Comorbid with Tic Disorder (TD)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

数字疗法应用于注意缺陷多动障碍（ADHD）、抽动障碍（TD）以及抽动障碍（TD）共患注意缺陷多动障碍（ADHD）儿童的前瞻性、基线对照 临床试验方案

Scientific title：

Prospective, Baseline Controlled Clinical Trial Protocol of Digital Therapy in Attention Deficit Hyperactivity Disorder (ADHD), Tic Disorder (TD), and Children with ADHD Comorbid with Tic Disorder (TD)

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：

魏欣 

研究负责人：

孙丹 

Applicant：

Weixin 

Study leader：

Sundan 

申请注册联系人电话：

Applicant telephone：

 18810757947

研究负责人电话：

Study leader's
telephone：

13971616910

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：

 weixin@fangcunyisheng.com

研究负责人电子邮件：

Study leader's E-mail：

 bioveriver@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：

北京市东城区隆福寺街95号wework2层方寸医生

研究负责人通讯地址：

湖北省武汉市江岸区香港路100号

Applicant address：

Wework 2 / F, Building 1, Longfu Cultural Innovation Park, 95 Longfusi Street, Dongcheng District, Beijing

Study leader's address：

no.100 Xianggang Road，Wuhan，Hubei Province

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：

华中科技大学同济医学院附属武汉儿童医院

Applicant's institution：

Wuhan Children's Hospital, Tongji Medical college, Huazhong University of science and technology

研究负责人所在单位：

华中科技大学同济医学院附属武汉儿童医院

Affiliation of the Leader：

Wuhan Children's Hospital, Tongji Medical college, Huazhong University of science and technology

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：

 2022I009-F01

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：

武汉儿童医院伦理委员会

Name of the ethic committee：

Ethics Committee of Wuhan Children's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-10-27 00:00:00

伦理委员会联系人：

肖晗

Contact Name of the ethic committee：

Han Xiao

伦理委员会联系地址：

武汉市香港路100号武汉儿童医院药物临床试验伦理委员会

Contact Address of the ethic committee：

Ethics Committee of Drug Clinical Trials, Wuhan Children's Hospital, No.100 Hong Kong Road, Wuhan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 27 82438516

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：

华中科技大学同济医学院附属武汉儿童医院

Primary sponsor：

Wuhan Children's Hospital, Tongji Medical college, Huazhong University of science and technology

研究实施负责（组长）单位地址：

湖北省武汉市江岸区香港路100号

Primary sponsor's address：

no.100 Xianggang Road，Wuhan，Hubei Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北

市(区县)：

武汉

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

华中科技大学同济医学院附属武汉儿童医院

具体地址：

武汉市江岸区香港路100号

Institution
hospital：

Wuhan Children's Hospital, Tongji Medical college, Huazhong University of science and technology

Address：

no.100 Xianggang Road，Wuhan，Hubei Province

经费或物资来源：

自筹

Source(s) of funding：

self-raised

研究疾病：

注意缺陷多动障碍（ADHD）、抽动障碍（TD）以及抽动障碍（TD）共患注意缺陷多动障碍（ADHD）  

Target disease：

Attention Deficit Hyperactivity Disorder (ADHD), Tic Disorder (TD), and Tic Disorder (TD) coexist with ADHD

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：

 其它 

Study phase：

N/A

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

（1）评估数字疗法产品MindPro1联合药物疗法对6-12岁ADHD儿童的疗效和安全性评价； （2）评估数字疗法产品MindPro1对6-12岁抽动障碍（TD）以及抽动障碍（TD）共患注意缺陷多动障碍（ADHD）儿童的疗效和安全性评价  

Objectives of Study：

（1）1Efficacy and safety evaluation of digital therapy product MindPro1 combined with drug therapy in ADHD children aged 6-12 years （2）To evaluate the efficacy and safety of digital therapy product MindPro1 in children aged 6-12 with tic disorder (TD) and tic disorder (TD) comorbid attention deficit hyperactivity disorder (ADHD

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

注意缺陷多动障碍（ADHD）亚方案的受试者的入选标准为：
(1) 符合美国精神障碍诊断与统计手册第五版（DSM-V）ADHD 诊断标准，注意力缺陷型或混合型患者；
(2) 6周岁≤年龄≤12周岁，性别不限；
(3）儿童韦氏智力量表≥80；
(4）入组前30天及以上在稳定遵循一二线标准治疗方案，并且试验期间保持原有方案和剂量继续治疗；
(5）具备依从研究计划完成治疗检测等相关要求的条件；
(6）患者和/或其监护人同意参加本研究，自愿签署知情同意书，8岁及以上的受试者还应签署儿童知情同意书。

TD亚方案受试者的入选标准为：
1、符合美国精神障碍诊断与统计手册第五版（DSM-V）抽动障碍诊断标准，病程超过一年的慢性抽动和图尔特综合征患者；
2、年满6周岁至12周岁，性别不限；
3、儿童韦氏智力量表≥80；
4、入组前30天及以上在稳定遵循一二线标准治疗方案，并且试验期间保持原有方案和剂量继续治疗；
5、具备依从研究计划完成治疗、检测等相关要求的条件；
6、患者和/或其监护人同意参加本研究，自愿签署知情同意书，8岁及以上的受试者还应签署儿童知情同意书。

Inclusion criteria

The inclusion criteria for subjects in the Attention Deficit Hyperactivity Disorder (ADHD) subprotocol are:
(1) Meet the diagnostic criteria for ADHD in the fifth edition of the American Diagnostic and Statistical Manual of Mental Disorders (DSM-V), attention-deficit or mixed patients;
(2) 6 years old ≤ age ≤ 12 years old, regardless of gender;
(3) Children's Wechsler Intelligence Scale ≥ 80;
(4) The first- and second-line standard treatment regimens were stably followed for 30 days or more before enrollment, and the original regimen and dose were maintained during the trial;
(5) Comply with the study plan to complete treatment testing
(6) Patients and/or their guardians agree to participate in this study and sign the informed consent form voluntarily, and subjects aged 8 years and above should also sign the informed consent form for children.

The inclusion criteria for the TD sub-protocol subjects are:
1. Patients with chronic tic and Tourt syndrome with a course of more than one year in accordance with the diagnostic criteria of the American Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) for tic disorders;
2. 6 to 12 years old, gender is not limited;
3. Children's Wechsler Intelligence Scale ≥ 80;
4. The first- and second-line standard treatment regimens were stably followed for 30 days or more before enrollment, and the original regimen and
5. Comply with the relevant requirements of the research plan to complete treatment, testing and other relevant requirements;
6. Patients and/or their guardians agree to participate in this study and voluntarily sign the informed consent form, and subjects aged 8 and above should also sign Children's Informed Consent.

排除标准：

注意缺陷多动障碍（ADHD）亚方案的受试者的排除标准为：
(1）患有脑瘫、癫痫、肾上腺脑白质营养不良等神经发育障碍性疾病；
(2）患有精神分裂症等严重精神疾病；
(3）听力障碍导致类似儿童注意缺陷–多动障碍表现者；
(4）经两种不同类别ADHD药物系统性治疗后仍无效的患者；
(5）色盲等不能正常使用软件者；
(6）既往或目前有游戏成瘾者；
(7）最近（过去6个月内）疑似药物滥用或依赖病史；
(8）家属报告或研究者观察到的妨碍干预的运动状态（如手/手臂的身体畸形或功能障碍、使用义肢等）；
(9）曾有自杀观念或研究者判断具有严重的自杀冲动者；
(10）1个月内正在参加其他临床试验尚未出组者；
(11）研究者认为不适合入组者。

TD亚方案受试者的排除标准为：
1、在过去3个月内有过改变抽动药物（开始或停止）历史，且目前治疗效果不稳定，需继续调整观察者；
2、过去6个月内经历2次及以上药物种类调整计划，且目前治疗效果仍未达预期者；
3、患有除入组指定共患病以外的，影响治疗计划执行和疗效结果判断的其他共患病者；
4、色盲、肢体功能障碍或姿势维持困难等不能正常使用软件者；
5、既往或目前有游戏成瘾者；
6、最近（过去6个月内）疑似药物滥用或依赖病史；
7、曾有自杀观念或研究者判断具有严重的自杀冲动者；
8、1个月内正在参加其他临床试验尚未出组者；
9、研究者认为不适合入组者。

Exclusion criteria：

Exclusion criteria for subjects in the Attention Deficit Hyperactivity Disorder (ADHD) subprotocol were:
(1) Suffering from neurodevelopmental disorders such as cerebral palsy, epilepsy, adrenoleukodystrophy;
(2) Suffering from serious mental diseases such as schizophrenia;
(3) Hearing impairment causes similar symptoms of attention deficit-hyperactivity disorder in children
(4) Those who are still ineffective after two different types of ADHD drug systemic treatment;
(5) Those who cannot use software normally, such as color blindness;
(6) Those who have past or current game addiction;
(7) Those who have recently (past) Within 6 months) Suspected history of drug abuse or dependence;
(8) Movement states reported by family members or observed by investigators that hinder intervention (such as physical deformity or dysfunction of hands/arms, use of prosthetic limbs, etc.);
(9) Ever have Suicidal ideation or those with severe suicidal impulses judged by the investigator;
(10) Those who are participating in other clinical trials within 1 month and have not yet been enrolled;
(11) Those who are considered unsuitable for enrollment by the investigator.

The exclusion criteria for subjects in the TD sub-protocol are:
1. History of changing tic drugs (starting or stopping) in the past 3 months, and the current treatment effect is unstable, and the observer needs to continue to be adjusted;
2. The past 6 months Those who have experienced 2 or more drug types adjustment plans within the past, and the current treatment effect has not yet reached the expected;
3. Those who suffer from other comorbidities other than those specified in the group, which affect the implementation of the treatment plan and the judgment of the efficacy results;
4. Those who cannot use the software normally, such as color blindness, limb dysfunction or difficulty in maintaining posture;
5. Past or current game addicts;
6. A history of suspected drug abuse or dependence recently (within the past 6 months);
7. Suicidal ideation or those with severe suicidal impulses judged by the investigator;
8. Those who are participating in other clinical trials within 1 month and have not yet been included in the group;
9. Those who are considered unsuitable for enrollment by the investigator.

研究实施时间：

Study execute time：

从 From 2022-12-15 00:00:00至 To 2025-09-29 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-12-15 00:00:00 至 To 2023-12-15 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 44

Group：

treatment group

Sample size：

干预措施：

对诊断为ADHD的6-12岁儿童采用数字疗法和药物疗法进行干预

干预措施代码：

Intervention：

Children aged 6-12 diagnosed with ADHD were intervened by digital therapy and drug therapy.

Intervention code：

组别：

试验组

样本量：

 20

Group：

treatment group

Sample size：

干预措施：

对诊断为TD并伴有ADHD共患病的6-12岁儿童采用数字疗法和药物疗法进行干预

干预措施代码：

Intervention：

Children aged 6-12 diagnosed as TD with ADHD comorbidity were intervened by digital therapy and drug therapy.

Intervention code：

组别：

试验组

样本量：

 20

Group：

treatment group

Sample size：

干预措施：

对诊断为TD，无其他共患病的6-12岁儿童采用数字疗法和药物疗法进行干预

干预措施代码：

Intervention：

Children aged 6-12 diagnosed with TD and without other comorbidities were intervened by digital therapy and drug therapy.

Intervention code：

组别：

试验组

样本量：

 10

Group：

treatment group

Sample size：

干预措施：

对诊断为TD，有或无其他共患病的6-12岁儿童只采用数字疗法进行干预

干预措施代码：

Intervention：

For children aged 6-12 who are diagnosed with TD, with or without other comorbidities, only digital therapy is used for intervention.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

 武汉市 

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

 华中科技大学同济医学院附属武汉儿童医院 

单位级别：

 三级甲等 

Institution
hospital：

Wuhan Children's Hospital, Tongji Medical college, Huazhong University of science and technology

Level of the institution：

Grade A tertiary hospital

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

 温州 

Country：

China

Province：

Zhejiang

City：

Wenzhou

单位(医院)：

 温州医科大学附属第二医院 

单位级别：

 三级甲等 

Institution
hospital：

The Second Affiliated Hospital of Wenzhou Medical University

Level of the institution：

grade A tertiary hospital

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

 南京 

Country：

China

Province：

Jiangsu

City：

Nanjing

单位(医院)：

 南京医科大学附属儿童医院 

单位级别：

 三级甲等 

Institution
hospital：

Children's Hospital Affiliated to Nanjing Medical University

Level of the institution：

grade A tertiary hospital

测量指标：

Outcomes：

指标中文名：

ADHD儿童干预4周后18项SNAP-IV-父母量表测评值较基线治疗应答率

指标类型：

主要指标

Outcome：

After 4 weeks of intervention for ADHD children, the response rate of 18 SNAP-IV- Parent Scale was higher than that of baseline treatment.

Type：

Primary indicator

测量时间点：

入组后4周

测量方法：

SNAP-IV量表

Measure time point of outcome：

4 weeks after joining the group

Measure method：

SNAP-IV scale

指标中文名：

ADHD儿童干预4周后TOVA-ACS较基线改善值

指标类型：

次要指标

Outcome：

TOVA-ACS data of ADHD children improved from baseline after 4 weeks of intervention.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

ADHD儿童干预4周后18项SNAP-IV-父母量表测评值较基线改善值

指标类型：

次要指标

Outcome：

After 4 weeks of intervention for ADHD children, the evaluation values of 18 SNAP-IV- Parent Scale were improved compared with the baseline values.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

ADHD儿童数字疗法治疗接纳率

指标类型：

次要指标

Outcome：

Acceptance rate of digital therapy for ADHD children

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

ADHD儿童数字疗法依从率

指标类型：

次要指标

Outcome：

Compliance rate of ADHD children with digital therapy

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

TD或TD共患ADHD的儿童采用数字疗法干预12周时与基线比较，评估受试者YGTSS- TTSS减分率

指标类型：

主要指标

Outcome：

Children with TD or TD with ADHD were treated with digital therapy for 12 weeks, and compared with the baseline, the decrease rate of YGTSS- TTSS was evaluated.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

TD儿童或TD共患ADHD儿童的临床疗效-总体改善（CGI-GI）在使用数字疗法4周、8周、12周时的评分较基线改善值

指标类型：

次要指标

Outcome：

The clinical efficacy-overall improvement (CGI-GI) score at 4 weeks, 8 weeks and 12 weeks after digital therapy was compared with the baseline improvement value.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

TD儿童或TD共患ADHD儿童的临床疗效-严重程度（CGI-SI）在使用数字疗法4周、8周、12周时的评分较基线改善值

指标类型：

次要指标

Outcome：

Clinical Efficacy-Severity (CGI-SI) scores at 4 weeks, 8 weeks and 12 weeks after digital therapy were improved compared with baseline values.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

TD儿童或TD共患ADHD儿童的临床疗效-疗效指数（CGI-EI)在使用数字疗法4周、8周、12周时的评分较基线改善值

指标类型：

次要指标

Outcome：

The clinical efficacy-efficacy index (CGI-EI) scores at 4 weeks, 8 weeks and 12 weeks after digital therapy were improved compared with the baseline values.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

TD儿童或TD共患ADHD儿童的Spence儿童焦虑量表在使用数字疗法4周、8周、12周时的测评值较基线改善值

指标类型：

次要指标

Outcome：

Spence children's anxiety scale improved compared with baseline after 4, 8 and 12 weeks of digital therapy.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

TD儿童或TD共患ADHD儿童的儿童九维健康效用（Child Health Utility 9D，CHU9D）量表在使用数字疗法4周、8周、 12周时的测评值较基线改善值

指标类型：

次要指标

Outcome：

The evaluation values of Child Health Utility 9D (CHU9D) scale after 4 weeks, 8 weeks and 12 weeks of digital therapy were improved compared with the baseline values.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

TD儿童或TD共患ADHD儿童的耶鲁全球抽动严重程度量表（YGTSS- TTSS）抽动总分在使用数字疗法4周、8周时的测评值较基线改善值

指标类型：

次要指标

Outcome：

The total twitch score of Yale Global Tic Severity Scale (YGTSS- TTSS) was improved from baseline after 4 weeks and 8 weeks of digital therapy.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

受试者父母汉密尔顿焦虑评定量表（Hamilton Anxiety Rating Scale,HAMA)在使用数 字疗法12周时的测评值较基线改善值

指标类型：

次要指标

Outcome：

The evaluation value of Hamilton anxiety rating scale (HAMA) of parents of the subjects after 12 weeks of digital therapy was improved compared with the baseline value.

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：

不适用

组织：

Sample Name：

NA

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 6 岁 years
最大 Max age 12 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）：

不适用

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：

Blinding：

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）：

试验完成6个月内公开上传到临床试验公共管理平台 ResMan (www.medresman.org)

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

Upload the trial to ResMan (www.medresman.org) within 6 months after completion of the trial.

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：

epidata电子采集和管理系统

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

Epidata electronic acquisition and management system

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-12-06 10:47:50