EpilepsyALF-MENCT07717632
AI-enhanced LF-MRI in Epilepsy
A study testing MRI in people with Epilepsy, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Sep 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Artificial Intelligence-enhanced Low Field
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.
Read the detailed description
The aim of this study is to determine the utility of AI-enhanced Low Field (AI-LF) MRI in the identification of focal brain lesions in adults with epilepsy. This is a proof-of-concept study evaluating the utility of AI-LF-MRI in aiding identification of potentially epileptogenic brain lesions, by comparing neuroradiologists' lesion detection on this modality versus standard HF-MRI. It will include ~30 adults with epilepsy who have undergone a high field (1.5T or 3T) MRI (HF-MRI) brain scan as part of their routine clinical care at University College London (UCL) Hospitals (UCLH), within the previous twelve months. Participants will be consecutively recruited and offered a LF-MRI brain scan on the 0.064T Swoop MR Imaging System (Hyperfine®) at the Birkbeck-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. Each participant will only have a single encounter with the study on the day they get their LF-MRI scan. There is no follow-up required with this study.
Inclusion criteria:
- Adults aged between >18 years and <70 years
- Diagnosis of epilepsy and attending a 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. Exclusion criteria
- Cognitive impairment that precludes ability to consent or assent to the study 2. Inability to lie flat for the duration of the scan 3. Body habitus incompatible with LF-MRI device 4. Presence of MRI contraindications as stipulated by standard MRI operating procedures
We will recruit at least 30 patients, of these, 20 patients will have a visible lesion on the HF-MRI scan (reference standard). A sample size of 20 patients will be sufficient to demonstrate that the proportion of lesions similarly identified is at least 0.8, against a null hypothesis of 0.5, using a one-sample, one-sided exact binomial test with a 5% significance level and a power of 80%. The rest will not have a visible potentially epileptogenic lesion on the HF-MRI scan.
Two consultant neuroradiologists will separately and independently report AI-LF- then HF-MRI scans according to set criteria, including, MRI scanner field strength, presence of lesion, lesion location and artefacts. They will be provided with basic participant clinical details such as age, seizure type and. EEG findings, but blinded to diagnosis. Rates of lesion detection and false positives in the AI-LF-MRI scans will be compared with the reference standard of a recent clinical HF-MRI and reported as proportions. Sensitivity and specificity analyses will be performed for the qualitative analysis of AI-LF-MRI. Intraclass coefficients and Bland Altman analyses will be used to compare quantitative inter-rater and inter-method agreement, respectively. Descriptive statistics such as medians (IQR) and proportions will be used to describe participants' demographic information and survey responses.
- Conditions
- Epilepsy
- Being tested
- MRI
- Keywords
- Low-field MRI, Low- and middle-income countries, Epilepsy, Neuroimaging, Resource-limited
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Also called Low-field
Low magnetic field MRI of the brain
| Study group | Role | What they receive |
|---|---|---|
| Low-field MRI Scan | Experimental | MRI Brain scan on the Hyperfine 0.064T Swoop System Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Rate of reported artefacts, including movement, blurring and signal inhomogeneity, on AI-LF-MRI compared to HF-MRI
Measured: 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
Compare agreement of lesions identified among radiologists reading the scans
Measured: 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.
Comparative analysis of hippocampal volume segmentation of the SuperSynth (AI tool) of low-field vs high-field MRI
Measured: Baseline assessment (within the study imaging visit)
Acceptability of the LF-MRI scanning process, assessed using participant responses to a custom acceptability questionnaire
Participants answer a custom-made questionnaire immediately after their low-field MRI scan on the Hyperfine. The questionnaire has closed-ended questions about their experience, with a few opportunities for open comment.
Measured: Baseline assessment (within the study imaging visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start18 Sep 2025
- Primary completion20 Feb 2026
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group. All participants will undergo a scan on the device being investigated for diagnostic accuracy.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals, The Leverhulme Trust
- Responsible party
- Sponsor
- Investigators
- John S Duncan, DM, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717632
- Sponsor's protocol ID
- 352304
- Other IDs
- 179646, 25/NE/0149
- Acronym
- ALF-ME
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Anonymised IPD may be shared with researchers within our institution (UCL). However, a plan has not yet been made for sharing the data more widely.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Artificial Intelligence-enhanced Low Field
- ClinicalTrials.gov ID
- NCT07717632
- Acronym / sponsor ID
- ALF-ME / 352304
- Conditions
- Epilepsy
- Keywords
- Low-field MRI, Low- and middle-income countries, Epilepsy, Neuroimaging, Resource-limited
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals, The Leverhulme Trust
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study is to determine the utility of AI-enhanced Low Field (AI-LF) MRI in the identification of focal brain lesions in adults with epilepsy. This is a proof-of-concept study evaluating the utility of AI-LF-MRI in aiding identification of potentially epileptogenic brain lesions, by comparing neuroradiologists' lesion detection on this modality versus standard HF-MRI. It will include ~30 adults with epilepsy who have undergone a high field (1.5T or 3T) MRI (HF-MRI) brain scan as part of their routine clinical care at University College London (UCL) Hospitals (UCLH), within the previous twelve months. Participants will be consecutively recruited and offered a LF-MRI brain scan on the 0.064T Swoop MR Imaging System (Hyperfine®) at the Birkbeck-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. Each participant will only have a single encounter with the study on the day they get their LF-MRI scan. There is no follow-up required with this study.
Inclusion criteria:
- Adults aged between >18 years and <70 years
- Diagnosis of epilepsy and attending a 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. Exclusion criteria
- Cognitive impairment that precludes ability to consent or assent to the study 2. Inability to lie flat for the duration of the scan 3. Body habitus incompatible with LF-MRI device 4. Presence of MRI contraindications as stipulated by standard MRI operating procedures
We will recruit at least 30 patients, of these, 20 patients will have a visible lesion on the HF-MRI scan (reference standard). A sample size of 20 patients will be sufficient to demonstrate that the proportion of lesions similarly identified is at least 0.8, against a null hypothesis of 0.5, using a one-sample, one-sided exact binomial test with a 5% significance level and a power of 80%. The rest will not have a visible potentially epileptogenic lesion on the HF-MRI scan.
Two consultant neuroradiologists will separately and independently report AI-LF- then HF-MRI scans according to set criteria, including, MRI scanner field strength, presence of lesion, lesion location and artefacts. They will be provided with basic participant clinical details such as age, seizure type and. EEG findings, but blinded to diagnosis. Rates of lesion detection and false positives in the AI-LF-MRI scans will be compared with the reference standard of a recent clinical HF-MRI and reported as proportions. Sensitivity and specificity analyses will be performed for the qualitative analysis of AI-LF-MRI. Intraclass coefficients and Bland Altman analyses will be used to compare quantitative inter-rater and inter-method agreement, respectively. Descriptive statistics such as medians (IQR) and proportions will be used to describe participants' demographic information and survey responses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group. All participants will undergo a scan on the device being investigated for diagnostic accuracy.
| Arm | Type | Receives |
|---|---|---|
| Low-field MRI Scan | Experimental | Diagnostic Test: MRIMRI Brain scan on the Hyperfine 0.064T Swoop System |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: Low-fieldLow magnetic field MRI of the brain | Diagnostic test | Low-field MRI Scan |
Primary outcome
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.
Time frame: 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.
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.
4 secondary outcomes
Proportion of scans with clinically significant artefacts, determined by blinded neuroradiologist assessment, on AI-LF-MRI compared with HF-MRI
Time frame: 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
Time frame: 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.
Time frame: Baseline assessment (within the study imaging visit)
Acceptability of the LF-MRI scanning process, assessed using participant responses to a custom acceptability questionnaire
Time frame: Baseline assessment (within the study imaging visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- SynthSR: A public AI tool to turn heterogeneous clinical brain scans into high-resolution T1-weighted images for 3D morphometryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Anonymised IPD may be shared with researchers within our institution (UCL). However, a plan has not yet been made for sharing the data more widely.
Related trials for Epilepsy
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
Enrolling by invitation
An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
Epilepsy
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Enrolling by invitationObservational study
Neurophysiological Intraoperative or Epilepsy Monitoring
Patients Operated on at the Neurosurgery Department
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John S Duncan, DM principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Epilepsy, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.