Epilepsies, PartialNCT06550726
High-resolution Multi-parametric Magnetic Resonance Imaging for Focal Epilepsy
A study testing Magnetic Resonance Imaging in people with Epilepsies, Partial, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Patients with focal epilepsy often have diagnostic difficulties as their culprit for seizures are difficult to be picked up using conventional imaging. The current study is to investigate the utility of advanced MRI sequences on detection of subtle lesions accountable for focal epilepsy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsies, Partial
- What is being tested?
- Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2024to 31 Aug 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consecutive patients with drug-resistant focal epilepsy fulfilling the following criteria -
- 1. Diagnosis of focal epilepsy with a probable site identified, as defined by concordant results from any TWO of the following:
- Clinical seminology compatible with focal epilepsy.
- Electroencephalography pointing towards a specific site for focal epilepsy.
- Positive ictal brain scintigraphy with SPECT-CT correlation. AND 2. Previous MRI (at least one study with protocol tailored for epilepsy) which did not reveal accountable focal lesion.
- AND 3. Able to consent for MRI examination (if patient under age of 18, consent for MRI will be obtained from guardian). Patients will be provided information leaflets to read on, and written consent before taking part in this study and MRI examination.
Who cannot join
- Patients who are contraindicated to magnetic resonance imaging (such as due to underlying MRI incompatible metallic implants)
- Patients who cannot cooperate for MRI scanning.
- Patients show are unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Gerald Choa MRI Center
Hong Kong
Gerald Choa MRI Center CUHK, 35051009, cumri@cuhk.edu.hk
About this study
Patients with focal epilepsy often have diagnostic difficulties as their culprit for seizures are difficult to be picked up using conventional imaging. The current study is to investigate the utility of advanced MRI sequences on detection of subtle lesions accountable for focal epilepsy.
Read the detailed description
Focal epilepsy refers to having seizures arising from a specific part of the brain. In these patients, workup in magnetic resonance imaging is often necessary as patients with structural lesions have a much higher rate of seizures, ranging from 10% to 26% at 1 year and from 29% to 48% at 5 years. However, there is also a subgroup of patients who has epilepsy not adequately controlled by anti-epileptics with unrevealing first MRI study, a dedicated MRI protocol may reveal positive lesion in 30-65% of the cases. In these patients, several tricks can be applied to increase the detection rate. First, the used of a high-resolution MRI on a high-field scanner could be helpful, which can be increased the sensitivity up to 90%. The use of 7T-MRI in further picking up subtle lesions in patients presenting with epilepsy has been investigated, further affirming the role of high resolution MRI imaging. Secondly, the use of dedicated sequences, such as T1-weighted inversion recovery sequences which allow better distinction of grey and white matter, could also reveal subtle lesions such as polymicrogyria or Type 1 focal cortical dysplasia.
This study is therefore aimed to apply the findings to the local settings, and specifically to investigate if T1-weighted inversion recovery sequences provides additional benefit in picking up more subtle lesions in patients who had an initial first negative MRI.
- Conditions
- Epilepsies, Partial
- Being tested
- Magnetic Resonance Imaging
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
Subjects will undergo MRI scanning in our 3T machine with dedicated high resolution sequences (including 2D T1-weighted inversion recovery sequences, 3D FLAIR MRI whole brain, 3D T1-weighted Sagittal MPRAGE; plus other sequences for the clinical purpose of pre-operative planning as per consensus with referring doctor)
| Study group | Role | What they receive |
|---|---|---|
| Study subjects | Experimental | Study subjects will be recruited for scanning in a 3T MRI scanner with dedicated high-resolution MRI sequences as stated in our research protocol. Receives: Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of high resolution MRI in diagnosis
the sensitivity and specificity of the baseline MRI (bMRI) and the high-resolution MRI (hrMRI) studies, based on the standard of surgical findings on patients who underwent either intracranial EEG or surgical resection
Measured: At the time of MRI scanning, typically 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Sep 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leung Ho Sang, Chinese University of Hong Kong
- Investigators
- Hanson Leung, MBBS (HK), Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550726
- Sponsor's protocol ID
- CREC 2024.133
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The image data and outcome measures of the participants can be provided in an anonymized manner upon reasonable request by email to the principal investigator.
Publications
Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.
PubMed 28276062Bernasconi A, Cendes F, Theodore WH, Gill RS, Koepp MJ, Hogan RE, Jackson GD, Federico P, Labate A, Vaudano AE, Blumcke I, Ryvlin P, Bernasconi N. Recommendations for the use of structural magnetic resonance imaging in the care of patients with epilepsy: A consensus report from the International League Against Epilepsy Neuroimaging Task Force. Epilepsia. 2019 Jun;60(6):1054-1068. doi: 10.1111/epi.15612. Epub 2019 May 28.
PubMed 31135062Krumholz A, Wiebe S, Gronseth GS, Gloss DS, Sanchez AM, Kabir AA, Liferidge AT, Martello JP, Kanner AM, Shinnar S, Hopp JL, French JA. Evidence-based guideline: Management of an unprovoked first seizure in adults: Report of the Guideline Development Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2015 Apr 21;84(16):1705-13. doi: 10.1212/WNL.0000000000001487.
PubMed 25901057Kokkinos V, Kallifatidis A, Kapsalaki EZ, Papanikolaou N, Garganis K. Thin isotropic FLAIR MR images at 1.5T increase the yield of focal cortical dysplasia transmantle sign detection in frontal lobe epilepsy. Epilepsy Res. 2017 May;132:1-7. doi: 10.1016/j.eplepsyres.2017.02.018. Epub 2017 Mar 2.
PubMed 28279892Mellerio C, Labeyrie MA, Chassoux F, Roca P, Alami O, Plat M, Naggara O, Devaux B, Meder JF, Oppenheim C. 3T MRI improves the detection of transmantle sign in type 2 focal cortical dysplasia. Epilepsia. 2014 Jan;55(1):117-22. doi: 10.1111/epi.12464. Epub 2013 Nov 15.
PubMed 24237393Hou P, Hasan KM, Sitton CW, Wolinsky JS, Narayana PA. Phase-sensitive T1 inversion recovery imaging: a time-efficient interleaved technique for improved tissue contrast in neuroimaging. AJNR Am J Neuroradiol. 2005 Jun-Jul;26(6):1432-8.
PubMed 15956512
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution Multi-parametric Magnetic Resonance Imaging for Focal Epilepsy
- ClinicalTrials.gov ID
- NCT06550726
- Acronym / sponsor ID
- CREC 2024.133
- Conditions
- Epilepsies, Partial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 13 Aug 2024 (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.
Patients with focal epilepsy often have diagnostic difficulties as their culprit for seizures are difficult to be picked up using conventional imaging. The current study is to investigate the utility of advanced MRI sequences on detection of subtle lesions accountable for focal epilepsy.
Detailed description
Focal epilepsy refers to having seizures arising from a specific part of the brain. In these patients, workup in magnetic resonance imaging is often necessary as patients with structural lesions have a much higher rate of seizures, ranging from 10% to 26% at 1 year and from 29% to 48% at 5 years. However, there is also a subgroup of patients who has epilepsy not adequately controlled by anti-epileptics with unrevealing first MRI study, a dedicated MRI protocol may reveal positive lesion in 30-65% of the cases. In these patients, several tricks can be applied to increase the detection rate. First, the used of a high-resolution MRI on a high-field scanner could be helpful, which can be increased the sensitivity up to 90%. The use of 7T-MRI in further picking up subtle lesions in patients presenting with epilepsy has been investigated, further affirming the role of high resolution MRI imaging. Secondly, the use of dedicated sequences, such as T1-weighted inversion recovery sequences which allow better distinction of grey and white matter, could also reveal subtle lesions such as polymicrogyria or Type 1 focal cortical dysplasia.
This study is therefore aimed to apply the findings to the local settings, and specifically to investigate if T1-weighted inversion recovery sequences provides additional benefit in picking up more subtle lesions in patients who had an initial first negative MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study subjects | Experimental | Diagnostic Test: Magnetic Resonance ImagingStudy subjects will be recruited for scanning in a 3T MRI scanner with dedicated high-resolution MRI sequences as stated in our research protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Consecutive patients with drug-resistant focal epilepsy fulfilling the following criteria -
- 1. Diagnosis of focal epilepsy with a probable site identified, as defined by concordant results from any TWO of the following:
- Clinical seminology compatible with focal epilepsy.
- Electroencephalography pointing towards a specific site for focal epilepsy.
- Positive ictal brain scintigraphy with SPECT-CT correlation. AND 2. Previous MRI (at least one study with protocol tailored for epilepsy) which did not reveal accountable focal lesion.
Key exclusion criteria (3 listed)
- Patients who are contraindicated to magnetic resonance imaging (such as due to underlying MRI incompatible metallic implants)
- Patients who cannot cooperate for MRI scanning.
- Patients show are unable to provide informed consent.
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 |
|---|---|---|
| Magnetic Resonance ImagingSubjects will undergo MRI scanning in our 3T machine with dedicated high resolution sequences (including 2D T1-weighted inversion recovery sequences, 3D FLAIR MRI whole brain, 3D T1-weighted Sagittal MPRAGE; plus other sequences for the clinical purpose of pre-operative planning as per consensus with referring doctor) | Diagnostic test | Study subjects |
Primary outcome
Accuracy of high resolution MRI in diagnosis
Time frame: At the time of MRI scanning, typically 1 day
the sensitivity and specificity of the baseline MRI (bMRI) and the high-resolution MRI (hrMRI) studies, based on the standard of surgical findings on patients who underwent either intracranial EEG or surgical resection
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 3 Apr 2026.
- Background: PubMed 28276062Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.
- Background: PubMed 31135062Bernasconi A, Cendes F, Theodore WH, Gill RS, Koepp MJ, Hogan RE, Jackson GD, Federico P, Labate A, Vaudano AE, Blumcke I, Ryvlin P, Bernasconi N. Recommendations for the use of structural magnetic resonance imaging in the care of patients with epilepsy: A consensus report from the International League Against Epilepsy Neuroimaging Task Force. Epilepsia. 2019 Jun;60(6):1054-1068. doi: 10.1111/epi.15612. Epub 2019 May 28.
- Background: PubMed 25901057Krumholz A, Wiebe S, Gronseth GS, Gloss DS, Sanchez AM, Kabir AA, Liferidge AT, Martello JP, Kanner AM, Shinnar S, Hopp JL, French JA. Evidence-based guideline: Management of an unprovoked first seizure in adults: Report of the Guideline Development Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2015 Apr 21;84(16):1705-13. doi: 10.1212/WNL.0000000000001487.
- Background: PubMed 28279892Kokkinos V, Kallifatidis A, Kapsalaki EZ, Papanikolaou N, Garganis K. Thin isotropic FLAIR MR images at 1.5T increase the yield of focal cortical dysplasia transmantle sign detection in frontal lobe epilepsy. Epilepsy Res. 2017 May;132:1-7. doi: 10.1016/j.eplepsyres.2017.02.018. Epub 2017 Mar 2.
- Background: PubMed 24237393Mellerio C, Labeyrie MA, Chassoux F, Roca P, Alami O, Plat M, Naggara O, Devaux B, Meder JF, Oppenheim C. 3T MRI improves the detection of transmantle sign in type 2 focal cortical dysplasia. Epilepsia. 2014 Jan;55(1):117-22. doi: 10.1111/epi.12464. Epub 2013 Nov 15.
- Background: PubMed 15956512Hou P, Hasan KM, Sitton CW, Wolinsky JS, Narayana PA. Phase-sensitive T1 inversion recovery imaging: a time-efficient interleaved technique for improved tissue contrast in neuroimaging. AJNR Am J Neuroradiol. 2005 Jun-Jul;26(6):1432-8.
- Individual participant dataSharing planned: Undecided. The image data and outcome measures of the participants can be provided in an anonymized manner upon reasonable request by email to the principal investigator.
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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.
Hanson Leung, MBBS (HK) principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Epilepsies, Partial, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 3 Apr 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 Hong Kong. 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?
Contact Hanson Leung, MBBS (HK) (35051009, lhs655@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of high resolution MRI in diagnosis (time frame: At the time of MRI scanning, typically 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06550726, which also lists 6 linked publications.
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 3 Apr 2026.