PUFFINS Brain Health Study (PUFFINS BH)

University of Aberdeen

Status: Not yet enrolling

Conditions: Cerebral Small Vessel Disease

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

Study type: Observational

Funder types: Other

Identifiers

NCT06947876

25/YH/0053 (Other Identifier)

2-079-24

Details and patient eligibility

About

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.

Enrollment: 85 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

85 participants in 4 patient groups

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

Description:

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

Treatment:

Other: Enrolment Field-cycling Imaging research scan

Other: Enrolment cognitive assessment interview

Other: Enrolment 3T MRI research scan

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

Description:

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

Treatment:

Other: Enrolment Field-cycling Imaging research scan

Other: Enrolment cognitive assessment interview

Other: Enrolment 3T MRI research scan

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

Description:

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

Treatment:

Other: Enrolment Field-cycling Imaging research scan

Other: Enrolment cognitive assessment interview

Other: Enrolment 3T MRI research scan

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

Description:

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.

Treatment:

Other: Follow up cognitive assessment interview

Other: Follow up 3T MRI research scan

Other: Follow up ultra-low field MRI research scan

Other: Enrolment ultra-low field MRI research scan

Other: Enrolment Field-cycling Imaging research scan

Other: Enrolment cognitive assessment interview

Other: Enrolment 3T MRI research scan

Other: Follow up Field-cycling Imaging research scan