Clinical Utility of Automated Electric Source Imaging in Presurgical Evaluation

NCT04218812 | Active Not Recruiting

• 1 other identifier: PROMAESIS
• Study Type: interventional
• Target: 250
• Locations: 8 countries
• Sites: 12

Brief 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

Keywords

Sensitivity; Specificity; Accuracy; Automated ESI; Refractory epilepsy; Epilepsy surgery; Clinical Utility

Outcome Measures

Primary Outcomes (2)

• The Sensitivity and Specificity of automated ESI in presurgical evaluation.

  For determining the the accuracy (sensitivity and specificity) of automated ESI, one year outcome after the operation will be calculated based on the defined criteria. * True Positive (TP): source is in the same sub-lobar region as the resection, seizure-free outcome * False Positive (FP): source is in the same sub-lobar region as the resection, not seizure-free outcome * True Negative (TN): source outside the sub-lobar region that was resected, not seizure-free outcome * False Negative (FN): source outside the sub-lobar region that was resected, seizure-free outcome.

  2 Years

• the clinical utility of ESI in management of the patient with medically refractory epilepsy

  For determining the clinical utility, the percentage of patients in whom automated ESI change decision on patients management will be calculated.

  2 years

Study Arms (2)

No electrical source imaging (ESI)

ACTIVE COMPARATOR

The multidisciplinary teams take decisions based on considering all data without ESI

Diagnostic Test: No electrical source imaging (ESI); Diagnostic Test: Automated electrical source imaging (ESI)

Automated Electrical source imaging (ESI)

EXPERIMENTAL

The multidisciplinary teams take decisions based on considering all data with ESI

Diagnostic Test: No electrical source imaging (ESI); Diagnostic Test: Automated electrical source imaging (ESI)

Interventions

No electrical source imaging (ESI) DIAGNOSTIC_TEST

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

Automated Electrical source imaging (ESI); No electrical source imaging (ESI)

Automated electrical source imaging (ESI) DIAGNOSTIC_TEST

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

Automated Electrical source imaging (ESI); No electrical source imaging (ESI)

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with drug resistant focal epilepsy, admitted to Epilepsy Monitoring Unit for presurgical evaluation, who are afterwards discussed at the multidisciplinary epilepsy surgery team meetings.

You may not qualify if:

• Patients who did not have a seizure during the monitoring.

Sponsors & Collaborators

• Sándor Beniczky: lead
• Filadelfia Epilepsy Hospital: collaborator
• Hospital del Mar: collaborator
• Brno Epilepsy Center: collaborator
• University Hospital Bucharest (Adult): collaborator
• Freiburg University: collaborator
• Kepler University Clinic, Linz: collaborator
• Motol University Hospital: collaborator
• Christian Doppler Klinik, Salzburg: collaborator
• Unidade Local de Saúde de Coimbra, EPE: collaborator
• Valencia University Hospital: collaborator
• Carlo Besta Institure, Milano: collaborator
• Hospital de Santa Maria, Lisbon: collaborator

Study Sites (12)

Kepler University Clinic

Linz, Austria

Location

Christian Doppler Klinik

Salzburg, Austria

Location

Motol University Hospital

Prague, Czech Rebuplic, Czechia

Location

Brno Epilepsy Center

Brno, Czech Republic, Czechia

Location

Danish Epilepsy Center

Dianalund, DK 4293, Denmark

Location

Freiburg University

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Location

Carlo Besta Institure

Milan, Italy

Location

Valencia University Hospital

Venice, Italy

Location

Centro Hospitalar e Universitário de Coimbra

Coimbra, Portugal

Location

Hospital de Santa Maria

Lisbon, Portugal

Location

University Hospital Bucharest

Bucharest, Romania

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (8)

• Boon P, D'Have M, Vanrumste B, Van Hoey G, Vonck K, Van Walleghem P, Caemaert J, Achten E, De Reuck J. Ictal source localization in presurgical patients with refractory epilepsy. J Clin Neurophysiol. 2002 Oct;19(5):461-8. doi: 10.1097/00004691-200210000-00009.

  PMID: 12477991 BACKGROUND

• Brodbeck V, Spinelli L, Lascano AM, Wissmeier M, Vargas MI, Vulliemoz S, Pollo C, Schaller K, Michel CM, Seeck M. Electroencephalographic source imaging: a prospective study of 152 operated epileptic patients. Brain. 2011 Oct;134(Pt 10):2887-97. doi: 10.1093/brain/awr243.

  PMID: 21975586 BACKGROUND

• Beniczky S, Lantz G, Rosenzweig I, Akeson P, Pedersen B, Pinborg LH, Ziebell M, Jespersen B, Fuglsang-Frederiksen A. Source localization of rhythmic ictal EEG activity: a study of diagnostic accuracy following STARD criteria. Epilepsia. 2013 Oct;54(10):1743-52. doi: 10.1111/epi.12339. Epub 2013 Aug 14.

  PMID: 23944234 BACKGROUND

• Megevand P, Spinelli L, Genetti M, Brodbeck V, Momjian S, Schaller K, Michel CM, Vulliemoz S, Seeck M. Electric source imaging of interictal activity accurately localises the seizure onset zone. J Neurol Neurosurg Psychiatry. 2014 Jan;85(1):38-43. doi: 10.1136/jnnp-2013-305515. Epub 2013 Jul 30.

  PMID: 23899624 BACKGROUND

• Rikir E, Koessler L, Gavaret M, Bartolomei F, Colnat-Coulbois S, Vignal JP, Vespignani H, Ramantani G, Maillard LG. Electrical source imaging in cortical malformation-related epilepsy: a prospective EEG-SEEG concordance study. Epilepsia. 2014 Jun;55(6):918-32. doi: 10.1111/epi.12591. Epub 2014 Apr 4.

  PMID: 24702598 BACKGROUND

• Lascano AM, Perneger T, Vulliemoz S, Spinelli L, Garibotto V, Korff CM, Vargas MI, Michel CM, Seeck M. Yield of MRI, high-density electric source imaging (HD-ESI), SPECT and PET in epilepsy surgery candidates. Clin Neurophysiol. 2016 Jan;127(1):150-155. doi: 10.1016/j.clinph.2015.03.025. Epub 2015 May 9.

  PMID: 26021550 BACKGROUND

• Maliia MD, Meritam P, Scherg M, Fabricius M, Rubboli G, Mindruta I, Beniczky S. Epileptiform discharge propagation: Analyzing spikes from the onset to the peak. Clin Neurophysiol. 2016 Apr;127(4):2127-33. doi: 10.1016/j.clinph.2015.12.021. Epub 2016 Jan 12.

  PMID: 26818882 BACKGROUND

• Mouthaan BE, Rados M, Barsi P, Boon P, Carmichael DW, Carrette E, Craiu D, Cross JH, Diehl B, Dimova P, Fabo D, Francione S, Gaskin V, Gil-Nagel A, Grigoreva E, Guekht A, Hirsch E, Hecimovic H, Helmstaedter C, Jung J, Kalviainen R, Kelemen A, Kimiskidis V, Kobulashvili T, Krsek P, Kuchukhidze G, Larsson PG, Leitinger M, Lossius MI, Luzin R, Malmgren K, Mameniskiene R, Marusic P, Metin B, Ozkara C, Pecina H, Quesada CM, Rugg-Gunn F, Rydenhag B, Ryvlin P, Scholly J, Seeck M, Staack AM, Steinhoff BJ, Stepanov V, Tarta-Arsene O, Trinka E, Uzan M, Vogt VL, Vos SB, Vulliemoz S, Huiskamp G, Leijten FS, Van Eijsden P, Braun KP; E-PILEPSY consortium. Current use of imaging and electromagnetic source localization procedures in epilepsy surgery centers across Europe. Epilepsia. 2016 May;57(5):770-6. doi: 10.1111/epi.13347. Epub 2016 Mar 25.

  PMID: 27012361 BACKGROUND

MeSH Terms

Conditions

Drug Resistant Epilepsy; Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Ricardo Rocamora, MD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

• Martin Pali, MD

  Brno Epilepsy Center

  PRINCIPAL INVESTIGATOR

• Ioana Mindruta, MD

  University Hospital Bucharest (Adult)

  PRINCIPAL INVESTIGATOR

• Andreas Schulze Bonhage, MD

  Freiburg University

  PRINCIPAL INVESTIGATOR

• Tim von Oertzen, MD

  Kepler University Clinic, Linz

  PRINCIPAL INVESTIGATOR

• Vdym Gnatkovsky, MD

  Carlo Besta Institure, Milano

  PRINCIPAL INVESTIGATOR

• Peter Marusic, MD

  Motol University Hospital

  PRINCIPAL INVESTIGATOR

• Markus Leitinger, MD

  Christian Doppler Klinik, Salzburg

  PRINCIPAL INVESTIGATOR

• Francisco Sales, MD

  Unidade Local de Saúde de Coimbra, EPE

  PRINCIPAL INVESTIGATOR

• vicente villanueva, MD

  Valencia University Hospital

  PRINCIPAL INVESTIGATOR

• Carla Bente, MD

  Hospital de Santa Maria,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Evaluation of automated electrical source imaging(ESI) in epilepsy surgery.

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 6, 2020
• Study Start: March 12, 2019
• Primary Completion: May 1, 2021
• Study Completion: December 31, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

CZ (2); DK (1); RO (1); PT (2); ES (1); DE (1); AU (2); IT (2)