ClinicalTrials.gg
RecruitingNCT06947876PUFFINS BHUpdated May 5, 2026

PUFFINS Brain Health Study

An observational study in Cerebral Small Vessel Disease, sponsored by University of Aberdeen. Recruiting at 2 sites in United Kingdom. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by University of Aberdeen · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
85
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Cerebral Small Vessel Diseases with a site in United Kingdom — 5 open to participants now, 6 under way, none of them phase 3. Cerebral Small Vessel Diseases · United Kingdom.

Started
2025
with 1 other
Observational
5 of 12
4 open now
Registered
12th of 12
by date
Lead sponsor
1 of 12
University of Aberdeen

Among the 12 studies in Cerebral Small Vessel Diseases with a site in United Kingdom, this one is one of 2 that started in 2025, is one of 5 observational ones, and was the 12th registered.

Cerebral Small Vessel Diseases

128 studies on the registry are indexed under Cerebral Small Vessel Diseases; 71 are open to participants now.

Browse Cerebral Small Vessel Diseases studies →

Open to participants now

5 of the 12 studies in Cerebral Small Vessel Diseases with a site in United Kingdom are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 46 Cerebral Small Vessel Diseases studies recruiting now, 26 (57%) set no upper age limit and 5 (11%) stop at 75 or younger; 2 take children under 18; 11 take healthy volunteers.

This study: 50 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description

Cerebral small vessel disease (SVD) is a major underlying contributor to ischaemic and haemorrhagic stroke, cognitive decline, and dementia. Neuroimaging features of SVD have been shown to be associated with increased risk of stroke occurrence, reoccurrence, and cognitive decline post-stroke. New approaches are needed that target SVD diagnosis, monitoring, and treatment, to improve outcomes across the stroke and cognitive decline care pathways. However, providing equitable access to advanced medical technologies across the Scottish population is becoming a significant burden on the NHS and wider clinical community. Low-field MRI, which is both more cost-effective and less complex to operate, has the potential to address this growing societal burden at a whole-population level. Whilst on-going research efforts remain focussed on developing new interventions to slow progression of SVD and improve treatment outcomes, work is also needed to improve approaches to assess SVD pathophysiology, severity, progression, and treatment outcome. Repeated assessment with magnetic resonance imaging (MRI), is recognised as the best solution to detect the multiple features that combine to produce SVD. This has the potential to identify markers of stroke risk and cognitive decline and, in future, guide tailored treatments to better manage stroke risk and improve post-stroke long-term outcomes. No other imaging technique, blood test or other assessment can provide the necessary information. However, the high cost and infrastructure demands of conventional MRI means that while it is feasible for clinical trials and research, it cannot realistically be used for widespread repeated brain imaging assessment, or screening, for SVD. For this reason, robust and reliable imaging methods that can be easily implemented across the whole Scottish population, rural/urban, wealthy/deprived must be developed. Operating at magnetic field strengths up to 10,000 times lower than conventional MRI, low-field MRI technologies provide a unique opportunity to make repeated brain imaging cost-effective and accessible in community and outpatient settings. The utility of commercially available portable low-field MRI technology, operating at a fixed field of 64 mT (milliTesla), has already been proven for imaging acute stroke at the bedside of patients and recent preliminary findings have indicated its feasibility to detect moderate and severe SVD. However, the novelty of portable low-field MRI means that its full potential has yet to be realised, and work is now required to develop low-field quantitative imaging approaches to enhance the capabilities of low-field MRI to extract underlying features related to brain health and SVD severity. We aim to provide a stepping-stone to optimised fixed low-field MRI technology by leveraging the unique capabilities of field-cycling imaging (FCI), a unique whole-body MRI technology developed at the University of Aberdeen. IRAS Form Reference: 25/PR/0216 IRAS Version 6.4.1 Date: 13/02/2025 350553/1711955/37/104 7Investigations using field-cycling technologies, which vary the strength of the magnetic field during acquisition, have shown unique sensitivity to tissue features and contrast mechanisms that are invisible at higher, fixed, magnetic fields such as 1.5 and 3T. Furthermore, using FCI, differences between healthy tissue and stroke pathology have been observed. Our own preliminary results, using the mark 2 FCI scanner to image patients with SVD at field strengths between 0.2 and 200 mT have shown a significant positive linear correlation between the volume of SVD extracted from FCI images and from 3T MRI images. However, these preliminary results, limited to a single slice acquisition at 3.1 x 3.1 x 10 mm resolution, do not provide the full evidence needed to design new, cost-effective and accessible, lowfield MRI scanners that would enable widespread, repeated brain imaging assessment for SVD. The objective of this proposal is therefore to address this evidence gap and to inform the design of new low-field MRI technologies tailored to extracting key markers of SVD. First, by utilising the unique capabilities of the new mark 3 FCI scanner, now onsite at Aberdeen Royal Infirmary, imaging data will be acquired at multiple different field strengths, and a higher pixel resolution. This data will be used to determine the most effective low-field approach to identify markers of SVD (e.g., white matter changes, reduced perfusion, microbleeds, recent lacunar infarcts) and SVD progression. Second, by acquiring imaging data from both field-cycling imaging (FCI) and a separate fixed low-field MRI scanner, the extent of agreement between assessments of SVD will be examined.

03

Conditions studied

  • Cerebral Small Vessel Disease

Keywords

  • Field-cycling imaging
  • Ultra-low field MRI
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • History of major stroke (minor stroke/ or lacunar stroke are acceptable).
  • Individuals unable to give .
  • to MRI scanning such as implantable cardiac devices.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
85 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants with mild small vessel disease (Fazekas score = 1)

    Participants with mild small vessel disease, defined by a Fazekas score of 1.

    Other: Enrolment 3T MRI research scan · Other: Enrolment Field-cycling Imaging research scan · Other: Enrolment cognitive assessment interview

  • Participants with moderate small vessel disease (Fazekas score = 2)

    Participants with mild small vessel disease, defined by a Fazekas score of 2.

    Other: Enrolment 3T MRI research scan · Other: Enrolment Field-cycling Imaging research scan · Other: Enrolment cognitive assessment interview

  • Participants with severe small vessel disease (Fazekas score = 3)

    Participants with mild small vessel disease, defined by a Fazekas score of 3.

    Other: Enrolment 3T MRI research scan · Other: Enrolment Field-cycling Imaging research scan · Other: Enrolment cognitive assessment interview

  • Follow up group. Participants with moderate or severe small vessel disease (Fazekas score = 2 or 3).

    Participants with moderate or severe SVD (deep white matter Fazekas 2 or 3) who will undergo an extra low-field MRI scan and will have a follow up visit at 18 months.

    Other: Enrolment 3T MRI research scan · Other: Enrolment Field-cycling Imaging research scan · Other: Enrolment ultra-low field MRI research scan · Other: Follow up 3T MRI research scan · Other: Follow up Field-cycling Imaging research scan · Other: Follow up ultra-low field MRI research scan · Other: Enrolment cognitive assessment interview · Other: Follow up cognitive assessment interview

Interventions

  • OtherEnrolment 3T MRI research scan

    Enrolment research scan performed with 3T magnetic resonance imaging scanner.

  • OtherEnrolment Field-cycling Imaging research scan

    Enrolment research scan performed with Field-Cycling Imaging scanner.

  • OtherEnrolment ultra-low field MRI research scan

    Enrolment research scan performed with ultra-low field MRI scanner

  • OtherFollow up 3T MRI research scan

    Follow up research scan performed with 3T magnetic resonance imaging scanner, 18-months after baseline scans.

  • OtherFollow up Field-cycling Imaging research scan

    Follow up research scan performed with Field-Cycling Imaging scanner, 18-months after baseline scans.

  • OtherFollow up ultra-low field MRI research scan

    Follow up research scan performed with Ultra-low field MRI scanner, 18-months after baseline scans.

  • OtherEnrolment cognitive assessment interview

    Enrolment interview performed to complete cognitive assessment scoring of Montreal Cognitive Assessment, EQ-5D, Trail making test, Animal naming test, controlled oral word association test, and Hopkins Verbal Learning Test.

  • OtherFollow up cognitive assessment interview

    Follow up interview performed to complete cognitive assessment scoring of Montreal Cognitive Assessment, EQ-5D, Trail making test, Animal naming test, controlled oral word association test, and Hopkins Verbal Learning Test. Performed 18-months after baseline interview.

06

What researchers measure

Primary outcomes

  1. Small vessel disease volume agreement between enrolment Field-Cycling Imaging and enrolment 3T MRI.

    Linear regression analysis will be performed between small vessel disease volume obtained from Field-Cycling Imaging (FCI) and 3T MRI. Sensitivity will be determined as the effect gradient (gradient of the line of best fit between FCI volume and 3T MRI volume). Precision will be determined as coefficient of variation. Agreement will be determined as Dice coefficient.

    Time frame: At enrolment

  2. Small vessel disease volume agreement between follow up Field-Cycling Imaging and follow up 3T MRI.

    Linear regression analysis will be performed between small vessel disease volume obtained from Field-Cycling Imaging (FCI) and 3T MRI. Sensitivity will be determined as the effect gradient (gradient of the line of best fit between FCI volume and 3T MRI volume). Precision will be determined as coefficient of variation. Agreement will be determined as Dice coefficient.

    Time frame: At 18 month follow up

Secondary outcomes

  1. Small vessel disease volume agreement between enrolment Field-Cycling Imaging and enrolment Ultra-low Field MRI.

    Linear regression analysis will be performed between small vessel disease volume obtained from Field-Cycling Imaging (FCI) and Ultra-low Field MRI. Sensitivity will be determined as the effect gradient (gradient of the line of best fit between FCI volume and Ultra-low Field MRI volume). Precision will be determined as coefficient of variation. Agreement will be determined as Dice coefficient.

    Time frame: At enrolment

  2. Small vessel disease volume agreement between follow up Field-Cycling Imaging and follow up Ultra-low Field MRI.

    Linear regression analysis will be performed between small vessel disease volume obtained from Field-Cycling Imaging (FCI) and Ultra-low Field MRI. Sensitivity will be determined as the effect gradient (gradient of the line of best fit between FCI volume and Ultra-low Field MRI volume). Precision will be determined as coefficient of variation. Agreement will be determined as Dice coefficient.

    Time frame: At 18 month follow up

  3. Strength of association between small vessel disease volume obtained from Field-Cycling Imaging, with small vessel disease severity (Fazekas score), age, mood, and cognition.

    Linear regression analysis will be performed to assess the strength of associations between small vessel disease volume obtained from Field-Cycling Imaging and small vessel disease severity (Fazekas score), age, mood and cognition derived from the memory, language, and processing speed measures.

    Time frame: At enrolment

  4. 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.

    Linear regression analysis will be performed to assess the strength of associations between small vessel disease volume obtained from ultra-low field MRI and small vessel disease severity (Fazekas score), age, mood and cognition derived from the memory, language, and processing speed measures.

    Time frame: At 18 month follow up

Other outcomes

  1. Extent of linear associations between relaxation rate measurements and multiparametric 3T MRI.

    General linear model analysis of relaxation rate measurements, apparent diffusion coefficient and transverse relaxation time, magnetitic transfer ratio, chemical exchange saturation transfer tissue pH, will be performed to investigate the linearity of associations. Exploratory factor analysis will be used to reduce number of 3T MRI parameters to hypothesised factors of microstructure integrity, iron concentration, degree of demyelination and tissue pH.

    Time frame: At enrolment

07

Study locations

2 of 2 sites recruiting
  • Aberdeen Biomedical Imaging Centre, University of Aberdeen
    Aberdeen, AB24 3FX, United Kingdom
    Recruiting
    • Gordon Waiter, PhD · Contactg.waiter@abdn.ac.uk · +44 1224 438356
    • Mary Joan MacLeod, PhD · Contactm.j.macleod@abdn.ac.uk · +44 1224 437842
    • Gordon D Waiter · Sub investigator
    • Adamu Ali-Gombe, PhD · Sub investigator
    • Nicholas Senn, PhD · Sub investigator
    • Mary Joan MacLeod, PhD · Principal investigator
  • AMT Center, Univeristy of Aberdeen
    Aberdeen, AB24 3FX, United Kingdom
    Recruiting
    • Mathieu Sarracanie, PhD · Contactmathieu.sarracanie@abdn.ac.uk · +44 1224 437365
    • Najat Salameh, PhD · Contactnajat.salameh@abdn.ac.uk · +44 1224 437360
    • Mathieu Sarracanie, PhD · Sub investigator
    • Najat Salameh, PhD · Sub investigator
    • Nicholas Senn, PhD · Sub investigator
    • Mary Joan MacLeod, PhD · Principal investigator
08

References and documents

Publications

  • 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 Jul;38(3):465-474. doi: 10.1007/s10334-025-01230-w. Epub 2025 Feb 15. PubMed 39955477 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2025 (actual). Primary completion is estimated for May 2027, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2025
First posted
Apr 27, 2025
StartActual
Dec 17, 2025
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
May 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06947876
Collaborators
NHS Grampian
Responsible party
Sponsor
First posted
Apr 27, 2025
Start date
Dec 17, 2025
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
May 5, 2026

Study contacts

Mary Joan MacLeod
Contact
m.j.macleod@abdn.ac.uk
+44 1224 438352
Gordon D Waiter
Contact
g.waiter@abdn.ac.uk
+44 1224 438356
Mary Joan MacLeod
study chair · University of Aberdeen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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