Haemdall: Developing a Quantitative MRI Biomarker of Infratentorial Superficial Siderosis of the Central Nervous System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Superficial Siderosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Haemdall: Developing a Quantitative MRI Biomarker of Classical (Infratentorial) Superficial Siderosis of the Central Nervous System
Overview
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.
Primary outcome measures
- To evaluate the association and clinical relevance of with markers of neurodegeneration and clinical assessments [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (1)
- Radiologist observational scoring and test-retest [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Perspectum — Oxford
Identifiers
NCT: NCT07098650 · 24/PR/1441