ElectroencephalographyPROMAESISNCT04218812
Clinical Utility of Automated Electric Source Imaging in Presurgical Evaluation
A study testing No electrical source imaging (ESI) and Automated electrical source imaging (ESI) in people with Electroencephalography and Refractory Epilepsy, run by Sándor Beniczky at 12 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Electroencephalography, Refractory Epilepsy, Brain Imaging
- What is being tested?
- No electrical source imaging (ESI) and Automated electrical source imaging (ESI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 12 sitesin 8 countries
- Study dates
- 12 Mar 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who did not have a seizure during the monitoring.
Trial locations and contacts
12 sites in 8 countries.
12 sites in 8 countries
Czechia2 sites
Brno Epilepsy Center
Brno, Czech Republic
Motol University Hospital
Prague, Czech Rebuplic
Portugal2 sites
Centro Hospitalar e Universitário de Coimbra
Coimbra
Hospital de Santa Maria
Lisbon
About this study
Official title: Prospective Multicenter Study on Localization Accuracy and Clinical Utility of Automated Electric Source Imaging in Presurgical Evaluation( PROMAESIS)
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.
Read the detailed description
One-third of patients with epilepsy have seizures resistant to pharmacotherapy. There are many approaches developed to control these seizures, yet epilepsy surgery is still the most common method. The crucial part of epilepsy surgery is to assess the epileptic zone in order to render patients seizure free. However, accurate localization of the epileptic zone is often challenging due to the multimodal approach. This contains semiology, EEG (obtained during long term video-EEG monitoring), magnetic resonance Imaging (MRI), in addition to certain cases, positron emission computed tomography (PET), and single photon emission computed tomography (SPECT) and magnetoencephalography (MEG). At present, in one of the third patients, seizure remains after epilepsy surgery. Therefore a new preoperative method should be improved to assess the epileptic zone. Automated ESI is a post-processing novel method that estimates the location in the brain of the source of the recorded EEG signals.
The objective of this study is:
- To determine the accuracy of ESI in localizing the epileptic focus.
- To determine the clinical utility of ESI on clinical decision making
Methods:
Study design: a prospective diagnostic study in line with the Standards for Reporting Diagnostic Accuracy Studies (STARD).
EEG was recorded using the International Federation of Clinical Neurophysiology (IFCN) electrode array of 25 electrodes including six electrodes in the Inferior temporal chain (F9/10, T9/10, and P9/10) in addition to the 19 electrodes of the 10-20 system. Electrode impedance was kept below 5 kilo-ohm. EEG was recorded with a sampling frequency of 256 Hz. The investigators will make a video on how to place the electrodes, to make sure all centers follow a standardized method. Multidisciplinary epilepsy teams classify that in the first step you should keep the multidisciplinary team blinded to the source imaging data, and make the implantation plan without the ESI results. Then show the ESI, adjust the plan and note the changes.
The multidisciplinary teams in different centers will classify seizures into "types." A seizure type is a group of seizures that have stereotypical semiology and ictal EEG. Maximum 3 seizures are registered for per type. After Long Term Monitoring, they provide Epilog and Brain Electrical Source Analysis (BESA) teams with datasets including MRI and Long Term Monitoring recording for each patient. For uploading datasets, multicenter teams will use the platform developed by Epilog. Afterward, Epilog and BESA teams (blinded to patient information) will run the automated source imaging-both for interictal epileptiform discharge (EDs) and ictal signs. Both software packages have CE mark for ESI. Finally, the multidisciplinary teams take decisions in two steps:
- Considering all data, except ESI II. Adding ESI to all other data.
At each step, the decisions are classified into one of the following categories:
- Stop (operation not recommended)
- Implantation of intracranial electrodes
- Operation
In addition, the changes are classified into one of the following categories:
- No change - but concordant with the decision.
- No change - but discordant with decision.
- Change from stop to implantation.
- Change from implantation to stop.
- Change in implantation plan: implantation of additional sites (besides the ones planned in step-1).
- Change from implantation of operation.
- Change from operation to implantation.
- Other (specify in free text). If changes are not related to all analyses results, it will be noted, which method(s) triggered the change (SLORETA-interictal / ictal; Equivalent Current Dipole - interictal/ictal; CLARA interictal/ictal).
At one-year follow-up, the changes are categorized as useful or not useful. A change is defined useful as follows: (a) change from stop to Intracranial Recording: the Intracranial Recording localized the source; (b) change in implantation strategy: the electrode(s) implanted based on the source imaging identified the source; (c) change from implantation to operation: the patient became seizure-free.
- Conditions
- Electroencephalography, Refractory Epilepsy, Brain Imaging, Surgery
- Being tested
- No electrical source imaging (ESI), Automated electrical source imaging (ESI)
- Keywords
- Sensitivity, Specificity, Accuracy, Automated ESI, Refractory epilepsy, Epilepsy surgery, Clinical Utility
- Medical subject headings
- Drug Resistant Epilepsy, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Diagnostic test
The automated source imaging consists of 2 phases
- Automated detection of EDs
- Source imaging of each spike cluster and seizure onset epoch.
| Study group | Role | What they receive |
|---|---|---|
| No electrical source imaging (ESI) | Active comparator | The multidisciplinary teams take decisions based on considering all data without ESI Receives: 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 Receives: Diagnostic Test: No electrical source imaging (ESI); Diagnostic Test: Automated electrical source imaging (ESI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start12 Mar 2019
- Primary completion1 May 2021
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ElectroencephalographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Evaluation of automated electrical source imaging(ESI) in epilepsy surgery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sándor Beniczky
- Sponsor type
- University, hospital or other
- Collaborators
- Filadelfia Epilepsy Hospital, Hospital del Mar, Brno Epilepsy Center, University Hospital Bucharest (Adult), University of Freiburg, Kepler University Clinic, Linz, Motol University Hospital, Christian Doppler Klinik, Salzburg, Unidade Local de Saúde de Coimbra, EPE, Hospital Clínico Universitario de Valencia, Carlo Besta Institure, Milano, Hospital de Santa Maria, Lisbon
- Responsible party
- Sponsor-investigator, Sándor Beniczky, Aarhus University Hospital
- Investigators
- Ricardo Rocamora, MD, Principal investigator, Hospital del MarMartin Pali, MD, Principal investigator, Brno Epilepsy CenterIoana Mindruta, MD, Principal investigator, University Hospital Bucharest (Adult)Andreas Schulze Bonhage, MD, Principal investigator, University of FreiburgTim von Oertzen, MD, Principal investigator, Kepler University Clinic, LinzVdym Gnatkovsky, MD, Principal investigator, Carlo Besta Institure, MilanoPeter Marusic, MD, Principal investigator, Motol University HospitalMarkus Leitinger, MD, Principal investigator, Christian Doppler Klinik, Salzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218812
- Sponsor's protocol ID
- PROMAESIS
- Acronym
- PROMAESIS
- Status last verified
- Feb 2024
- First submitted
- 30 Dec 2019
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12477991Brodbeck 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.
PubMed 21975586Beniczky 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.
PubMed 23944234Megevand 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.
PubMed 23899624Rikir 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.
PubMed 24702598Lascano 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.
PubMed 26021550Maliia 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.
PubMed 26818882Mouthaan 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.
PubMed 27012361
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study on Localization Accuracy and Clinical Utility of Automated Electric Source Imaging in Presurgical Evaluation( PROMAESIS)
- ClinicalTrials.gov ID
- NCT04218812
- Acronym / sponsor ID
- PROMAESIS / PROMAESIS
- Conditions
- Electroencephalography, Refractory Epilepsy, Brain Imaging, Surgery
- Keywords
- Sensitivity, Specificity, Accuracy, Automated ESI, Refractory epilepsy, Epilepsy surgery, Clinical Utility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sándor BeniczkyUniversity, hospital or other
- Collaborators
- Filadelfia Epilepsy Hospital, Hospital del Mar, Brno Epilepsy Center, University Hospital Bucharest (Adult), University of Freiburg, Kepler University Clinic, Linz, Motol University Hospital, Christian Doppler Klinik, Salzburg, Unidade Local de Saúde de Coimbra, EPE, Hospital Clínico Universitario de Valencia, Carlo Besta Institure, Milano, Hospital de Santa Maria, Lisbon
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
One-third of patients with epilepsy have seizures resistant to pharmacotherapy. There are many approaches developed to control these seizures, yet epilepsy surgery is still the most common method. The crucial part of epilepsy surgery is to assess the epileptic zone in order to render patients seizure free. However, accurate localization of the epileptic zone is often challenging due to the multimodal approach. This contains semiology, EEG (obtained during long term video-EEG monitoring), magnetic resonance Imaging (MRI), in addition to certain cases, positron emission computed tomography (PET), and single photon emission computed tomography (SPECT) and magnetoencephalography (MEG). At present, in one of the third patients, seizure remains after epilepsy surgery. Therefore a new preoperative method should be improved to assess the epileptic zone. Automated ESI is a post-processing novel method that estimates the location in the brain of the source of the recorded EEG signals.
The objective of this study is:
- To determine the accuracy of ESI in localizing the epileptic focus.
- To determine the clinical utility of ESI on clinical decision making
Methods:
Study design: a prospective diagnostic study in line with the Standards for Reporting Diagnostic Accuracy Studies (STARD).
EEG was recorded using the International Federation of Clinical Neurophysiology (IFCN) electrode array of 25 electrodes including six electrodes in the Inferior temporal chain (F9/10, T9/10, and P9/10) in addition to the 19 electrodes of the 10-20 system. Electrode impedance was kept below 5 kilo-ohm. EEG was recorded with a sampling frequency of 256 Hz. The investigators will make a video on how to place the electrodes, to make sure all centers follow a standardized method. Multidisciplinary epilepsy teams classify that in the first step you should keep the multidisciplinary team blinded to the source imaging data, and make the implantation plan without the ESI results. Then show the ESI, adjust the plan and note the changes.
The multidisciplinary teams in different centers will classify seizures into "types." A seizure type is a group of seizures that have stereotypical semiology and ictal EEG. Maximum 3 seizures are registered for per type. After Long Term Monitoring, they provide Epilog and Brain Electrical Source Analysis (BESA) teams with datasets including MRI and Long Term Monitoring recording for each patient. For uploading datasets, multicenter teams will use the platform developed by Epilog. Afterward, Epilog and BESA teams (blinded to patient information) will run the automated source imaging-both for interictal epileptiform discharge (EDs) and ictal signs. Both software packages have CE mark for ESI. Finally, the multidisciplinary teams take decisions in two steps:
- Considering all data, except ESI II. Adding ESI to all other data.
At each step, the decisions are classified into one of the following categories:
- Stop (operation not recommended)
- Implantation of intracranial electrodes
- Operation
In addition, the changes are classified into one of the following categories:
- No change - but concordant with the decision.
- No change - but discordant with decision.
- Change from stop to implantation.
- Change from implantation to stop.
- Change in implantation plan: implantation of additional sites (besides the ones planned in step-1).
- Change from implantation of operation.
- Change from operation to implantation.
- Other (specify in free text). If changes are not related to all analyses results, it will be noted, which method(s) triggered the change (SLORETA-interictal / ictal; Equivalent Current Dipole - interictal/ictal; CLARA interictal/ictal).
At one-year follow-up, the changes are categorized as useful or not useful. A change is defined useful as follows: (a) change from stop to Intracranial Recording: the Intracranial Recording localized the source; (b) change in implantation strategy: the electrode(s) implanted based on the source imaging identified the source; (c) change from implantation to operation: the patient became seizure-free.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Evaluation of automated electrical source imaging(ESI) in epilepsy surgery.
| Arm | Type | Receives |
|---|---|---|
| No electrical source imaging (ESI) | Active comparator | Diagnostic Test: No electrical source imaging (ESI), Diagnostic Test: Automated electrical source imaging (ESI)The multidisciplinary teams take decisions based on considering all data without ESI |
| Automated Electrical source imaging (ESI) | Experimental | Diagnostic Test: No electrical source imaging (ESI), Diagnostic Test: Automated electrical source imaging (ESI)The multidisciplinary teams take decisions based on considering all data with ESI |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who did not have a seizure during the monitoring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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), No electrical source imaging (ESI) |
| 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. | Diagnostic test | Automated Electrical source imaging (ESI), No electrical source imaging (ESI) |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Background: PubMed 12477991Boon 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.
- Background: PubMed 21975586Brodbeck 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.
- Background: PubMed 23944234Beniczky 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.
- Background: PubMed 23899624Megevand 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.
- Background: PubMed 24702598Rikir 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.
- Background: PubMed 26021550Lascano 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.
- Background: PubMed 26818882Maliia 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.
- Background: PubMed 27012361Mouthaan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Rocamora, MD principal investigator
Hospital del Mar
Martin Pali, MD principal investigator
Brno Epilepsy Center
Ioana Mindruta, MD principal investigator
University Hospital Bucharest (Adult)
12 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No electrical source imaging (ESI) and Automated electrical source imaging (ESI) in people with Electroencephalography and Refractory Epilepsy, run by Sándor Beniczky at 12 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Austria, Czechia, Italy, Portugal, Denmark and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Sensitivity and Specificity of automated ESI in presurgical evaluation. (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04218812, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.