PUFFINS Brain Health Study

NCT06947876 | Recruiting

• 2 other identifiers: 2-079-2425/YH/0053
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Small Vessel Disease

Keywords

Field-cycling imaging; Ultra-low field MRI

Outcome Measures

Primary Outcomes (2)

• 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.

  At enrolment

• 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.

  At 18 month follow up

Secondary Outcomes (4)

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

  At enrolment

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

  At 18 month follow up

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

  At enrolment

• 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.

  At 18 month follow up

Other Outcomes (1)

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

  At enrolment

Study Arms (4)

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

Enrolment 3T MRI research scan OTHER

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

Follow up group. Participants with moderate or severe small vessel disease (Fazekas score = 2 or 3).; Participants with mild small vessel disease (Fazekas score = 1); Participants with moderate small vessel disease (Fazekas score = 2); Participants with severe small vessel disease (Fazekas score = 3)

Enrolment Field-cycling Imaging research scan OTHER

Enrolment research scan performed with Field-Cycling Imaging scanner.

Follow up group. Participants with moderate or severe small vessel disease (Fazekas score = 2 or 3).; Participants with mild small vessel disease (Fazekas score = 1); Participants with moderate small vessel disease (Fazekas score = 2); Participants with severe small vessel disease (Fazekas score = 3)

Enrolment ultra-low field MRI research scan OTHER

Enrolment research scan performed with ultra-low field MRI scanner

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

Follow up 3T MRI research scan OTHER

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

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

Follow up Field-cycling Imaging research scan OTHER

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

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

Follow up ultra-low field MRI research scan OTHER

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

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

Enrolment cognitive assessment interview OTHER

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.

Follow up group. Participants with moderate or severe small vessel disease (Fazekas score = 2 or 3).; Participants with mild small vessel disease (Fazekas score = 1); Participants with moderate small vessel disease (Fazekas score = 2); Participants with severe small vessel disease (Fazekas score = 3)

Follow up cognitive assessment interview OTHER

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.

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (2)

Aberdeen Biomedical Imaging Centre, University of Aberdeen

Aberdeen, AB24 3FX, United Kingdom

RECRUITING

AMT Center, Univeristy of Aberdeen

Aberdeen, AB24 3FX, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 39955477 BACKGROUND

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mary Joan MacLeod

  University of Aberdeen

  STUDY CHAIR

Central Study Contacts

Mary Joan MacLeod

CONTACT

+44 1224 438352; m.j.macleod@abdn.ac.uk

Gordon D Waiter

CONTACT

+44 1224 438356; g.waiter@abdn.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 27, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-06

Locations

GB (2)