Haemdall: Developing a Quantitative MRI Biomarker of Classical (Infratentorial) Superficial Siderosis of the Central Nervous System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Perspectum
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the association and clinical relevance of with markers of neurodegeneration and clinical assessments
研究概览
简要总结
Haemdall: Using Medical Imaging to measure Brain Iron in Superficial Siderosis.
This study is looking at a new way of using MRI scans to potentially measure the amount of iron on the surface of the brain. Iron build up in the brain is linked to how superficial siderosis develops. The study will also aim to see if there is a connection between the amount of iron in the brain and common superficial siderosis symptoms. Clinical tests will be used to measure symptoms including tests to measure your hearing, walking & balance and participants' ability to remember, think and understand.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Superficial siderosis cohort:
- •Male or female adults of 18 years of age or older with a confirmed diagnosis of superficial siderosis
- •Participants who have the capacity and a level of English proficiency that allows him/her to communicate well with the Investigator, understand and comply with the requirements of the investigation, read all participant facing documentation, as well as read and sign the informed consent form.
- •Participants willing and able to give informed consent for participation in the investigation
- •Healthy cohort:
- •Male or female over 18 years of age without a diagnosis of a neurological disorder
- •Participants who have the capacity and a level of English proficiency that allows him/her to communicate well with the Investigator, understand and comply with the requirements of the investigation, read all participant facing documentation, as well as read and sign the informed consent form.
- •Participants willing and able to give informed consent for participation in the investigation
排除标准
- •The participant may not enter the investigation if they have any contraindication to magnetic resonance imaging (including pregnancy, extensive tattoos, pacemaker, shrapnel injury or metallic unfixed implanted devices, metallic fragments, severe claustrophobia and cochlear implants)
- •Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the investigation, or may influence the result of the investigation, or the participant's ability to participate in the investigation
- •Participants who do not demonstrate the capacity to understand the investigation information or provide informed consent
结局指标
主要结局
To evaluate the association and clinical relevance of with markers of neurodegeneration and clinical assessments
时间窗: through study completion, an average of 1 year
1. Correlation between magnetic susceptibility assessed by QSM and brain cognitive function by MoCA. 2. Correlations between magnetic susceptibility assessed by QSM and: a) markers of neurodegeneration; and b) clinical assessment outcomes (auditory, balance, gait, cognitive)
次要结局
- Radiologist observational scoring and test-retest(through study completion, an average of 1 year)