PUFFINS Brain Health Study
- Conditions
- Cerebral Small Vessel Disease
- Registration Number
- NCT06947876
- Lead Sponsor
- University of Aberdeen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 85
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Small vessel disease volume agreement between enrolment Field-Cycling Imaging and enrolment 3T MRI. At enrolment 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.Small vessel disease volume agreement between follow up Field-Cycling Imaging and follow up 3T MRI. At 18 month follow up 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.
- Secondary Outcome Measures
Name Time Method Small vessel disease volume agreement between enrolment Field-Cycling Imaging and enrolment Ultra-low Field MRI. At enrolment 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.Small vessel disease volume agreement between follow up Field-Cycling Imaging and follow up Ultra-low Field MRI. At 18 month follow up 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.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 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.
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 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.
Trial Locations
- Locations (2)
Aberdeen Biomedical Imaging Centre, University of Aberdeen
🇬🇧Aberdeen, United Kingdom
AMT Center, Univeristy of Aberdeen
🇬🇧Aberdeen, United Kingdom