Clinical Utility of ESI in Presurgical Evaluation of Patients With Epilepsy

Summary

This study evaluates to what extend electrical source imaging (ESI) provides nonredundant information in the evaluation of epilepsy surgery candidates. Epilepsy surgery normally requires an extensive multimodal workup to identify the epileptic focus. This workup includes Magnetic Resonance Imaging (MRI), electroencephalography (EEG) without source imaging, video monitoring and when needed Positron Emission Tomography (PET), Magnetoencephalography (MEG), Single Photon Emission Computed Tomography (SPECT) and invasive EEG recordings using implanted electrodes. ESI estimates the location of the epileptic source with a high sensitivity and specificity using inverse source estimation methods on non-invasive EEG recordings. This study aims to investigate the clinical utility of ESI using low-density (LD, 25 channels) and high-density (HD, 256 channels) EEG. Clinical utility is defined in this study as the proportion of patients in whom the patient management plan was changed, based on the results of ESI. Should ESI be added to the routine work-up of epilepsy surgery candidates.

Conditions

• Electroencephalography
• Refractory Epilepsy
• Brain Imaging
• Surgery

Interventions

DIAGNOSTIC_TEST

Low-density ESI (LD ESI)

Electrical source imaging using low density EEG

DIAGNOSTIC_TEST

High-density ESI (HD ESI)

Electrical source imaging using high density EEG

DIAGNOSTIC_TEST

No electrical source imaging (ESI)

For all patients: MRI, semiology, visual interpretation of EEG. When needed: PET, SPECT.

Sponsors & Collaborators

• Filadelfia Epilepsy Hospital

  collaborator OTHER

• Lundbeck Foundation

  collaborator OTHER

• Lennart Grams Mindefond, Danish Epilepsy Society

  collaborator UNKNOWN

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Olaf B Paulson, MD, DMSc · Rigshospitalet, N-6931

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-02

Primary Completion

2018-11-01

Completion

2018-11-01

Countries

• Denmark

Study Locations