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Clinical Utility of Automated Electric Source Imaging in Presurgical Evaluation (PROMAESIS)

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ClinicalTrials.gov Identifier: NCT04218812
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : January 14, 2020
Sponsor:
Collaborators:
Danish Epilepsy Center, Dianalund,Denmark
Hospital del Mar
Brno Epilepsy Center
University Hospital Bucharest (Adult)
Freiburg University
Kepler University Clinic, Linz
Motol University Hospital, Prague
Christian Doppler Klinik, Salzburg
Centro Hospitalar e Universitário de Coimbra, E.P.E.
Valencia University Hospital
Carlo Besta Institure, Milano
Hospital de Santa Maria, Lisbon
Information provided by (Responsible Party):
Sándor Beniczky, Aarhus University Hospital

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.

Condition or disease Intervention/treatment Phase
Electroencephalography Refractory Epilepsy Brain Imaging Surgery Diagnostic Test: No electrical source imaging (ESI) Diagnostic Test: Automated electrical source imaging (ESI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Evaluation of automated electrical source imaging(ESI) in epilepsy surgery.
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Prospective Multicenter Study on Localization Accuracy and Clinical Utility of Automated Electric Source Imaging in Presurgical Evaluation( PROMAESIS)
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No electrical source imaging (ESI)
The multidisciplinary teams take decisions based on considering all data without ESI
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.

Experimental: Automated Electrical source imaging (ESI)
The multidisciplinary teams take decisions based on considering all data with ESI
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.




Primary Outcome Measures :
  1. The Sensitivity and Specificity of automated ESI in presurgical evaluation. [ Time Frame: 2 Years ]

    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. the clinical utility of ESI in management of the patient with medically refractory epilepsy [ Time Frame: 2 years ]
    For determining the clinical utility, the percentage of patients in whom automated ESI change decision on patients management will be calculated.



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Ages Eligible for Study:   1 Year to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218812


Contacts
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Contact: Sandor Beniczky, PhD, MD +45 5827 1185 sbz@filadelfia.dk
Contact: Mustafa Aykut Kural, MD +45 2481 1885 mustafaaykutkural@gmail.com

Locations
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Austria
Kepler University Clinic Recruiting
Linz, Austria
Contact: Tim von Oertzen       Tim.vonOertzen@kepleruniklinikum.at   
Christian Doppler Klinik Recruiting
Salzburg, Austria
Contact: Markus Leitinger, MD       ma.leitinger@salk.at   
Czechia
Motol University Hospital Recruiting
Prague, Czech Rebuplic, Czechia
Contact: Peter Marusic, MD       Petr.Marusic@fnmotol.cz   
Brno Epilepsy Center Recruiting
Brno, Czech Republic, Czechia
Contact: Martin Pali, MD       martin.pail@fnusa.cz   
Denmark
Danish Epilepsy Center Recruiting
Dianalund, Denmark, DK 4293
Contact: Sandor Beniczky, PhD,MD    +45 5827 1192    sbz@filadelfia.dk   
Germany
Freiburg University Recruiting
Freiburg, Baden-Wurttemberg, Germany
Contact: Andreas Schulze Bonhage, MD       andreas.schulze-bonhage@uniklinik-freiburg.de   
Italy
Carlo Besta Institure Recruiting
Milano, Italy
Contact: Vdym Gnatkovsky, MD         
Contact       Vadym.Gnatkovsky@istituto-besta.it   
Valencia University Hospital Recruiting
Venice, Italy
Contact: vicente villanueva, MD       vevillanuevah@yahoo.es   
Portugal
Centro Hospitalar e Universitário de Coimbra Recruiting
Coimbra, Portugal
Contact: Francisco Sales, MD       fsales5016@gmail.com   
Hospital de Santa Maria Recruiting
Lisbon, Portugal
Contact: Carla Bentes, MD       ccbentes@gmail.com   
Romania
University Hospital Bucharest Recruiting
Bucharest, Romania
Contact: Ioana Mindruta, MD       ioanamindruta@me.com   
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Ricardo Rocamora, MD       99151@parcdesalutmar.cat   
Sponsors and Collaborators
Sándor Beniczky
Danish Epilepsy Center, Dianalund,Denmark
Hospital del Mar
Brno Epilepsy Center
University Hospital Bucharest (Adult)
Freiburg University
Kepler University Clinic, Linz
Motol University Hospital, Prague
Christian Doppler Klinik, Salzburg
Centro Hospitalar e Universitário de Coimbra, E.P.E.
Valencia University Hospital
Carlo Besta Institure, Milano
Hospital de Santa Maria, Lisbon
Investigators
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Principal Investigator: 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, Prague
Principal Investigator: Markus Leitinger, MD Christian Doppler Klinik, Salzburg
Principal Investigator: Francisco Sales, MD Centro Hospitalar e Universitário de Coimbra, E.P.E.
Principal Investigator: vicente villanueva, MD Valencia University Hospital
Principal Investigator: Carla Bente, MD Hospital de Santa Maria,
  Study Documents (Full-Text)

Documents provided by Sándor Beniczky, Aarhus University Hospital:
Study Protocol  [PDF] August 8, 2018


Publications:
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, Özkara 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, Vulliémoz 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.

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Responsible Party: Sándor Beniczky, Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04218812    
Other Study ID Numbers: PROMAESIS
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sándor Beniczky, Aarhus University Hospital:
Sensitivity
Specificity
Accuracy
Automated ESI
Refractory epilepsy
Epilepsy surgery
Clinical Utility
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases