High-resolution Multi-parametric Magnetic Resonance Imaging for Focal Epilepsy

NCT ID: NCT06550726

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2027-08-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study subjects

Study subjects will be recruited for scanning in a 3T MRI scanner with dedicated high-resolution MRI sequences as stated in our research protocol.

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: DIAGNOSTIC_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)

Interventions

Magnetic Resonance Imaging

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)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Leung Ho Sang

Associate Consultant, Department of Imaging and interventional Radiology, Prince of Wales Hospital, the Chinese University of Hong Kong

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanson Leung, MBBS (HK)

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Gerald Choa MRI Center

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Hanson Leung, MBBS (HK)

Role: CONTACT

lhs655@ha.org.hk

35051009

Facility Contacts

Gerald Choa MRI Center CUHK

Role: primary

cumri@cuhk.edu.hk

35051009

References

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.

Reference Type: BACKGROUND

PMID: 28276062 (View on PubMed)

Bernasconi 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.

Reference Type: BACKGROUND

PMID: 31135062 (View on PubMed)

Krumholz 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.

Reference Type: BACKGROUND

PMID: 25901057 (View on PubMed)

Kokkinos 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.

Reference Type: BACKGROUND

PMID: 28279892 (View on PubMed)

Mellerio 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.

Reference Type: BACKGROUND

PMID: 24237393 (View on PubMed)

Hou 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.

Reference Type: BACKGROUND

PMID: 15956512 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CREC 2024.133

Identifier Type: -

Identifier Source: org_study_id