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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPerspectum

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Male or female over 18 years of age without a diagnosis of a neurological disorder

Disqualifiers

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

Trial population

50 participants from around the UK

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 2 trial groups
Group A: Superficial siderosis cohort
Group B: Healthy volunteer cohort

Trial outcomes

Primary outcomes

1

To evaluate the association and clinical relevance of with markers of neurodegeneration and clinical assessments

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)

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Radiologist observational scoring and test-retest

1. The agreement between radiologist scored observational level of iron accumulation via the Queens Square Superficial Siderosis (QUASARS) rating scale and quantitative MRI measure related to iron on the brain surface. The QUASARS rating is out of 36 points; with higher scores indicate a worse outcome 2. The repeatability coefficient within a single scanning session

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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