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

NCT06550726 | Recruiting

• 1 other identifier: CREC 2024.133
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsies, Partial

Outcome Measures

Primary Outcomes (1)

• 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

  At the time of MRI scanning, typically 1 day

Study Arms (1)

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.

Diagnostic Test: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging 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)

Study subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients with drug-resistant focal epilepsy fulfilling the following criteria -
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Gerald Choa MRI Center

Hong Kong, Hong Kong

RECRUITING

Related Publications (6)

• 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.

  PMID: 28276062 BACKGROUND

• 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.

  PMID: 31135062 BACKGROUND

• 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.

  PMID: 25901057 BACKGROUND

• 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.

  PMID: 28279892 BACKGROUND

• 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.

  PMID: 24237393 BACKGROUND

• 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.

  PMID: 15956512 BACKGROUND

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hanson Leung, MBBS (HK)

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanson Leung, MBBS (HK)

CONTACT

35051009; lhs655@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is performed during the study
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant, Department of Imaging and interventional Radiology, Prince of Wales Hospital, the Chinese University of Hong Kong

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 13, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

HK (1)