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正在招募不适用编号 NCT07634809

Evaluation of the Relationship Between Medication, Eye Movements, and Autonomic Nervous System (ANS) Functions in Children and Adolescents With ADHD

报名条件(概要)

  • 年龄:6 Years – 17 Years
  • 性别:不限
  • 健康志愿者:不接受

完整入排标准请以官方页面为准。

开展国家/地区

Sweden

药品与企业信息

The participants will be patients that were assessed to be candidates for, and offered treatment with, ADHD medication of the type methylphenidate, within the ordinary CAP practice. That is, participants will not be exposed to substances they would otherwise not take.

研发企业

Umeå University研究机构/其他

试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

合作机构

  • Region VästerbottenOTHER_GOV
  • Stockholm University研究机构/其他

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。

研究简介(原文)

An increasing number of children are being diagnosed with ADHD, and the demand for ADHD medication has been rising. Although ADHD medication is often effective, this is unfortunately not the case for all children and adolescents with ADHD; furthermore, the majority of those who use the medication experience side effects of some kind. There are currently no known factors that are clearly linked to whether ADHD medications will be effective or cause significant side effects. The healthcare system therefore has limited ability to provide recommendations on ADHD medication at the individual level, which means that most children and adolescents with ADHD try medication. Studies show that 35% of children aged 4-11 and 53% of 12-17-year-olds discontinue ADHD medication within a year. Perhaps these children and adolescents could have avoided fruitless treatment attempts if the healthcare system had been able to provide better recommendations regarding when ADHD medications are most likely to be effective and tolerable treatment options. This, combined with reports of rising mental health issues and an avalanche-like increase in demand for child and adolescent psychiatric services, makes it particularly urgent to develop methods for offering effective interventions to the right patients as specifically as possible. Previous studies have not consistently identified factors (neither genetic nor other factors such as gender, age, symptom severity, symptom profile, or comorbidities) that are linked to the efficacy or side effects of ADHD medications. In this project, we will investigate whether the efficacy and side effects of ADHD medications are linked to eye movements or activity within the autonomic nervous system. The autonomic nervous system is the part of our nervous system that is not under our conscious control. It controls many bodily functions such as pupil size, heart rate, blood pressure, and reactions to stress. Eye and pupil movements are measures of where an individual's attention is directed and how activated the brain is. ADHD is a condition in which the individual has difficulty regulating attention and activity. Therefore, there may be reason to believe that eye movements could be significant in the treatment of ADHD, even though this has never been studied before. Nor has the connection between the autonomic nervous system and the effects of ADHD medications been studied previously, even though changes in heart rate and blood pressure are among the common side effects of ADHD medications. We will invite children and adolescents who are about to begin ADHD medication. Before they start taking the medication, we will measure eye movements, pupil dilation, and the pupil's reaction to light using so-called eye-tracking technology. This is done by having the child or adolescent look at a screen and follow certain instructions while the pupil's movements are measured. We will also measure heart rate variability, i.e., how much the pulse varies, which can be done by continuously measuring the pulse for 10 minutes. We will investigate whether there is a correlation between the characteristics of these eye movement, pupil, and heart factors before medication begins and the extent to which the medication produces effect and side effects. We will also analyze how these factors are affected by the medication. The advantage of these factors is that they can be measured without causing pain. Furthermore, they are objective because they measure time and distance and are therefore not dependent on anyone's personal perceptions, as is so often the case with the rating scales otherwise used in psychiatry. If we can identify correlations between eye movements and activity in the autonomic nervous system and how ADHD medications affect children and adolescents with ADHD, there is a possibility that this could be used to provide better recommendations regarding ADHD medication. Many children could then be recommended other interventions first and avoid unnecessary and unpleasant drug treatments.

适应症

ADHD - Attention Deficit Disorder With Hyperactivity

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

查看完整申请路径与成功率说明 →

总联系人(申办方/研究总部)

研究中心联系方式

问自己是否符合条件、如何预筛

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英文版(发给研究团队)

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Evaluation of the Relationship Between Medication, Eye Movements, and Autonomic Nervous System (ANS) Functions in Children and Adolescents With ADHD
ClinicalTrials.gov Identifier: NCT07634809
Sponsor: Umeå University
Investigational product: metylphenidate

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照(供您核对)

尊敬的研究团队:

我是一位来自中国的患者,希望咨询参加以下临床试验的可能:

研究名称:Evaluation of the Relationship Between Medication, Eye Movements, and Autonomic Nervous System (ANS) Functions in Children and Adolescents With ADHD
试验编号:NCT07634809
申办方:Umeå University
研究药物:metylphenidate

我的基本情况:
- 年龄:(请填写)
- 性别:(请填写)
- 确诊疾病与分期:(请填写)
- 基因/标志物检测:暂无
- 既往及当前治疗:(请填写)
- 体能状态(ECOG):未评估
- 目前所在城市:中国
- 可前往范围:(请填写)

想请教三个问题:
1. 我是否可能符合本研究的入组标准?
2. 哪个中心对我最方便可行?能否远程预筛?
3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)?

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
(您的姓名)
(您的邮箱/带国际区号的电话)
用邮件客户端发送给 linda.halldner@umu.se

提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。

下一步怎么做?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。
在 ClinicalTrials.gov 查看官方页面