Clinical trial NCT06947876: PUFFINS Brain Health Study
Official title: Proving the Utility of Ultra-low Field MRI for Assessing Brain Health
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Small Vessel Disease
Keywords: Field-cycling imaging
Ultra-low field MRI
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Grampian
First posted: 2025-04-27
Enrollment: 85
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who small vessel disease, Fazekas score 1 to 3. Study population will be recruited from the NHS Grampian region.

Brief summary: Small vessel disease (SVD) is a major cause of stroke and contributor to dementia cases. As work continues to develop new treatments to address the impact of SVD, new imaging techniques are needed to identify and track the progression of brain changes that occur with SVD. Magnetic Resonance Imaging (MRI) is the gold standard to diagnose poor brain health due to small vessel disease. However, current MRI systems are expensive and complex to operate, and so access is limited.

Low-field MRI technology, operating at magnetic field strengths many times lower than conventional MRI, can make brain imaging much more cost-effective and accessible. However, further work is needed to develop low-field MRI towards clinically feasible assessments of brain health. The University of Aberdeen hosts a unique network of researchers and imaging technologies that is now making it possible to test and develop different low-field MRI approaches towards solving key healthcare challenges.

The aim of this study is to evaluate the potential of two distinct approaches, field-cycling imaging (FCI) and ultra-low field MRI (ULF-MRI), to detect brain changes linked with small vessel disease. Automated methods will be developed to analyse images and extract measurements that detect and track progression of disease severity.


Eligibility criteria: Inclusion Criteria:

* Adults ≥ 50 years old.
* Subjects who do not report problems with memory.
* Small vessel disease (Fazekas score 1 to 3).
* Suitable body habitus.
* Able to understand written and spoken English.

Exclusion Criteria:

* History of major stroke (minor stroke/Transient Ischaemic Attacks or lacunar stroke are acceptable).
* Individuals unable to give informed consent.
* Contra-indications to MRI scanning such as implantable cardiac devices.

Primary outcomes:
measure: Small vessel disease volume agreement between enrolment Field-Cycling Imaging and enrolment 3T MRI.
timeFrame: At enrolment
measure: Small vessel disease volume agreement between follow up Field-Cycling Imaging and follow up 3T MRI.
timeFrame: At 18 month follow up
Secondary outcomes:
measure: Small vessel disease volume agreement between enrolment Field-Cycling Imaging and enrolment Ultra-low Field MRI.
timeFrame: At enrolment
measure: Small vessel disease volume agreement between follow up Field-Cycling Imaging and follow up Ultra-low Field MRI.
timeFrame: At 18 month follow up
measure: Strength of association between small vessel disease volume obtained from Field-Cycling Imaging, with small vessel disease severity (Fazekas score), age, mood, and cognition.
timeFrame: At enrolment
measure: Strength of association between small vessel disease volume obtained from Ultra-low Field MRI, with small vessel disease severity (Fazekas score), age, mood, and cognition.
timeFrame: At 18 month follow up
Other outcomes:
measure: Extent of linear associations between relaxation rate measurements and multiparametric 3T MRI.
timeFrame: At enrolment
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Biomedical Imaging Centre, University of Aberdeen
city: Aberdeen
country: United Kingdom
facility: AMT Center, Univeristy of Aberdeen
Study officials:
affiliation: University of Aberdeen
name: Mary Joan MacLeod
role: STUDY_CHAIR
References:
citation: Senn N, Ross PJ, Ayde R, Mallikourti V, Krishna A, James C, de Vries CF, Broche LM, Waiter GD, MacLeod MJ. Field-cycling imaging yields repeatable brain R1 dispersion measurement at fields strengths below 0.2 Tesla with optimal fitting routine. MAGMA. 2025 Feb 15. doi: 10.1007/s10334-025-01230-w. Online ahead of print.