NCT05513794已完成不适用
Prospective Data Collect Study for Development of Neurimelanin Image Analysis System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Heuron Inc.
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- Differences in Neuromelanin Volume by Age
研究概览
简要总结
In order to develop an image analysis system that automatically detects and quantifies neuromelanin, this study aims to construct a database of a wide sample by collecting brain MRI neuromelanin images prospectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parkinsin group
- •Inclusion Criteria:
- •Adults over 19 years old
- •Those who have clinically shown Parkinson's symptoms such as tremor, Rigidity, Bradykinesa and gait disturbance and are scheduled to take MRI scans
- •Dopamine transporter imaging shows a significant decrease in visual dopamine intake
- •A person who can read and understand the description and informed consent form
- •Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions
排除标准
- •Patient with a history of claustrophobia and mental illness;
- •Patient with metallic substances in the body
- •Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period
- •Pregnant or lactating women
- •Other cases where the investigator judged that it is difficult to participate in the study;
- •Healthy volunteer group
- •Inclusion Criteria:
- •Adults over 19 years old
- •A person who has no family history or diagnostic history of movement disorders;
- •A person with a score of 8 or higher on the CCSIT(cross cultural smell identification test)
- •A person with a score of 27 or higher on the MMSE Test
- •No Parkinson's symptoms on a neurological examination
- •Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions
- •Exclusion Criteria:
- •Patient with a history of central nervous system disease or cognitive disorder
- •Patient with a history of claustrophobia and mental illness;
- •Patient with metallic substances in the body
- •Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period
- •Pregnant or lactating women
- •Other cases where the investigator judged that it is difficult to participate in the study;
研究组 & 干预措施
Patient group
Experimental
Patient with parkinson disease
干预措施: MRI Imaging (Device)
Healthy volunteer group
Experimental
Healthy volunteer
干预措施: MRI Imaging (Device)
结局指标
主要结局
Differences in Neuromelanin Volume by Age
时间窗: Within 1 weeks after enrollment
Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age
次要结局
- Differences in Neuromelanin Volume by group(Within 1 weeks after enrollment)
研究者
研究点 (3)
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