Haemdall: Developing a Quantitative MRI Biomarker of Infratentorial Superficial Siderosis of the Central Nervous System

Официальное название

Haemdall: Developing a Quantitative MRI Biomarker of Classical (Infratentorial) Superficial Siderosis of the Central Nervous System

Обзор

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.

Первичные конечные точки

• To evaluate the association and clinical relevance of with markers of neurodegeneration and clinical assessments [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (1)

• Radiologist observational scoring and test-retest [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• Perspectum — Oxford

Идентификаторы

NCT: NCT07098650 · 24/PR/1441

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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