AI-enhanced LF-MRI in Epilepsy

NCT07717632 | Active Not Recruiting DMC FDA Device

• 3 other identifiers: 35230417964625/NE/0149
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The global burden of epilepsy is high affecting over 50 million people worldwide. Majority live in low- and middleincome countries (LMICs) where access to diagnosis and treatment is limited. Accurate diagnosis of epilepsy and identification of the underlying cause through brain imaging is key to providing appropriate treatment. Magnetic resonance imaging (MRI) is the recommended modality of choice for brain imaging. However, in many LMICs it is scarce, and the cost of maintenance is unattainable. This study aims to explore the usefulness of a lower cost, more portable MRI machine for epilepsy diagnosis. It will be a proof-of-concept study evaluating the utility of low magnetic field MRI (LF-MRI) in epilepsy diagnosis. It will include 30 adults with epilepsy who have undergone a high field MRI (HF-MRI) brain scan as part of their routine clinical care under the University College London (UCL) Hospitals (UCLH), within twelve months of recruitment. Participants will be consecutively recruited and offered a LF-MRI brain scan on the Swoop MR Imaging System (Hyperfine) at the Birbeck-UCL Centre for Neuroimaging (BUCNI). Image post-processing will be performed using the open access machine learning program, LF-SynthSR, to enhance the image quality and allow for quantitative image analysis. Anonymised HF- and LF-MRI scans will be independently reported using a structured reporting template by two neuroradiologists. A perception survey will be administered to all participants to assess their tolerability of the LF-MRI. This study will serve as a foundation for future studies in this field and in areas where such innovations are most needed.

Conditions

Epilepsy

Keywords

Low-field MRI; Low- and middle-income countries; Epilepsy; Neuroimaging; Resource-limited

Outcome Measures

Primary Outcomes (1)

• Sensitivity of AI-LF-MRI for lesion detection, measured as the proportion of lesions identified on HF-MRI that are also detected on AI-LF-MRI by blinded neuroradiologist review.

  The rate of correctly identified abnormalities on the AI-enhanced low-field MRI when compared to standard of care high-field MRI. There is no pre-specified "good" rate assigned for this pilot study.

  Baseline assessment (within the study imaging visit). Participant will only undergo a low-field MRI scan which will be compared to a reference high-field MRI scan done within 12 months of enrolment.

Secondary Outcomes (4)

• Proportion of scans with clinically significant artefacts, determined by blinded neuroradiologist assessment, on AI-LF-MRI compared with HF-MRI

  Baseline assessment (within the study imaging visit)

• Inter-rater agreement among blinded neuroradiologists for qualitative lesion detection and classification on AI-LF-MRI and HF-MRI, measured using Cohen's kappa for pairwise agreement between raters and Fleiss' kappa for agreement across all raters

  Baseline assessment (within the study imaging visit)

• Inter-method agreement between AI-LF-MRI and HF-MRI for quantitative imaging measures, assessed using Bland-Altman analysis.

  Baseline assessment (within the study imaging visit)

• Acceptability of the LF-MRI scanning process, assessed using participant responses to a custom acceptability questionnaire

  Baseline assessment (within the study imaging visit)

Study Arms (1)

Low-field MRI Scan

EXPERIMENTAL

MRI Brain scan on the Hyperfine 0.064T Swoop System

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Low magnetic field MRI of the brain

Also known as: Low-field

Low-field MRI Scan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged between \>17 years and \<70 years
• Diagnosis of epilepsy and attending at UCLH-affiliated outpatient epilepsy clinic
• Undergone a 1.5T or 3T MRI Brain scan within 12 months of recruitment as part of standard clinical care
• Can tolerate MRI scanning without sedation.

You may not qualify if:

• Cognitive impairment that precludes ability to consent or assent to the study
• Inability to lie flat
• Body habitus incompatible with LF-MRI device
• Presence of MRI contraindications as stipulated by standard MRI operating procedures

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator
• The Leverhulme Trust: collaborator

Study Sites (1)

UCL Queen Square Institute of Neurology

London, United Kingdom

Location

Related Links

• SynthSR: A public AI tool to turn heterogeneous clinical brain scans into high-resolution T1-weighted images for 3D morphometry

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• John S Duncan, DM

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group. All participants will undergo a scan on the device being investigated for diagnostic accuracy.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 21, 2026
• Study Start: September 18, 2025
• Primary Completion: February 20, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

GB (1)