Clinical Utility of Automated Electric Source Imaging in Presurgical Evaluation

Summary

Electrical source imaging is part of the presurgical evaluation of patients with drug-resistant focal epilepsy. The software packages that will be used in this study have Declaration of Conformity within the European Economic Area (CE mark) for this specific medical use. In spite of being part of the clinical standard, the evidence for the accuracy and clinical utility of these methods are derived from several smaller-scale and retrospective studies. The PROMAESIS study will provide solid evidence of the accuracy and clinical utility of automated ESI.

Conditions

• Electroencephalography
• Refractory Epilepsy
• Brain Imaging
• Surgery

Interventions

DIAGNOSTIC_TEST

No electrical source imaging (ESI)

For all patients: MRI, semiology, visual interpretation of EEG, and in selected cases, PET, SPECT

DIAGNOSTIC_TEST

Automated electrical source imaging (ESI)

The automated source imaging consists of 2 phases 1. Automated detection of EDs 2. Source imaging of each spike cluster and seizure onset epoch.

Sponsors & Collaborators

• Filadelfia Epilepsy Hospital

  collaborator OTHER

• Hospital del Mar

  collaborator OTHER

• Brno Epilepsy Center

  collaborator UNKNOWN

• University Hospital Bucharest (Adult)

  collaborator UNKNOWN

• Freiburg University

  collaborator UNKNOWN

• Kepler University Clinic, Linz

  collaborator UNKNOWN

• Motol University Hospital

  collaborator OTHER

• Christian Doppler Klinik, Salzburg

  collaborator UNKNOWN

• Unidade Local de Saúde de Coimbra, EPE

  collaborator OTHER

• Valencia University Hospital

  collaborator UNKNOWN

• Carlo Besta Institure, Milano

  collaborator UNKNOWN

• Hospital de Santa Maria, Lisbon

  collaborator UNKNOWN

• Sándor Beniczky

  lead OTHER

Principal Investigators

• Ricardo Rocamora, MD · Hospital del Mar

• Martin Pali, MD · Brno Epilepsy Center

• Ioana Mindruta, MD · University Hospital Bucharest (Adult)

• Andreas Schulze Bonhage, MD · Freiburg University

• Tim von Oertzen, MD · Kepler University Clinic, Linz

• Vdym Gnatkovsky, MD · Carlo Besta Institure, Milano

• Peter Marusic, MD · Motol University Hospital

• Markus Leitinger, MD · Christian Doppler Klinik, Salzburg

• Francisco Sales, MD · Unidade Local de Saúde de Coimbra, EPE

• vicente villanueva, MD · Valencia University Hospital

• Carla Bente, MD · Hospital de Santa Maria,

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

1 Year

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-12

Primary Completion

2021-05-01

Completion

2024-12-31

Countries

• Austria
• Czechia
• Denmark
• Germany
• Italy
• Portugal
• Romania
• Spain

Study Locations