- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03882151
Added Value of Automated Electrical Source Localization (EPILOG PreOp®) to Presurgical Evaluation of Refractory Epilepsy (EPILOG)
What is the Added Clinical Value of an Automated EEG Analysis Program With Electrical Source Localization (EPILOG PreOp®) as Part of the Pre-surgical Assessment of Non-lesional Refractory Epilepsy?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Saint-Luc University Hospital (CUSL) are the sponsor of the study. The study is bi-centric, in collaboration with the William Lennox Neurological Hospital Center (CHNWL).
Will be included prospectively the first thirty patients with refractory focal epilepsy being evaluated at CUSL or CHNWL between for surgery, and for whom the cerebral MRI 3 Tesla (3T) did not show any obvious causal lesion.
The pre-surgical evaluation includes (standard of care - SOC):
- EEG-video scalp monitoring (SOC)
- MRI 3Tesla (SOC)
- PET scan FDG (SOC)
- neuropsychological assessment (SOC) MRI examination will be reviewed by an experienced neuroradiologist at CUSL (SOC).
The automated EEG analysis and electrical source localization with EPILOG PreOp® (non-SOC) will be carried out by Epilog (Epilog, Ghent, Belgium), blind to the rest of the workup. The costs of this analysis are 250 € / patient and will be covered by a clinical research fund. If the patient is referred by the CUSL, the costs are charged to account 830 E. If the patient is referred by the CHNWL, the costs are charged to a local scientific account.
The results of the pre-surgical evaluation will be discussed in a multidisciplinary meeting, blind to the results of EPILOG PreOp®, in order to determine the presumed localization of the epileptogenic zone as well as the management plan. The result of this discussion will be classified as follows:
- A focal surgical resection is possible;
- B the assessment must be completed by an invasive EEG (SOC);
C the option of resective surgery is rejected. If an invasive EEG is considered, the anatomical location of electrodes is planned. Then, the results of EPILOG PreOp® are presented (by Dr. Susana Ferrao Santos) and their influence on the management is evaluated. The possible change of care in relation to the initial plan is considered to be relevant if the EPILOG PreOp® analysis results in
- a modification of the therapeutic decision as defined above,
- a modification of the invasive EEG implantation plan or
- the use of an additional non-invasive imaging method to delineate the epileptogenic zone or to establish the functional risk.
Patients will then be followed for 6 months to determine the clinical relevance of any management changes derived from the EPILOG PreOp® analysis. We will also evaluate the relationship between the localization of the EPILOG + regions (ie the brain regions involved in the irritative zone according to the results provided by the EPILOG PreOp® analysis), the surgical resection, the pathology analysis results and post-surgical results.
EPILOG PreOp® analysis will be carried out using the full length EEG recording collected during video-EEG monitoring (SOC) at CUSL or CHNWL, ie 7 days of recording. with 19-27 electrodes placed according to the international 10-20 system. The EEG data will be transmitted after acquisition and anonymization. For patients investigated at CHNWL, a high-density (non-SOC) recording with 64-76 electrodes will be offered for 24 to 48 hours if the investigator deems it necessary. The additional costs associated with high density EEG are borne by the CHNWL. The result will also be sent to Epilog for analysis, after anonymisation of the data.
The EPILOG PreOp® analysis will begin with automated detection of interictal epileptiform activity using the Persyst program (Persyst Spike Detector P13, Persyst, San Diego, CA, USA), and interictal activity will be clustered and localized. source will be estimated using the sLORETA inverse solution model, using the methodology described previously.
Pathology For all patients undergoing resective surgery, histological sections will be reviewed (SOC). Focal cortical dysplasias will be classified according to the ILAE (SOC) classification. Non-contributory results include: gliosis, absence of microscopic or histological abnormality.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susana Ferrao Santos, MD, PhD
- Phone Number: 027647801
- Email: susana.ferrao@uclouvain.be
Study Locations
-
-
-
Brussels, Belgium, 1200
- Recruiting
- Saint-Luc University Hospital
-
Contact:
- Susana Ferrao Santos, MD, PhD
- Phone Number: 003227647801
- Email: susana.ferrao@uclouvain.be
-
Ottignies, Belgium, 1340
- Recruiting
- Centre Hospitalier William Lennox
-
Contact:
- Pascal Vrielynck, MD
- Phone Number: 003210430338
- Email: pascal.vrielynck@chnwl.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- drug resistant epilepsy under presurgical evaluation
- non lesional 3Tesla MRI scan
- epileptic seizure(s) recorded during video-EEG monitoring
Exclusion Criteria:
- patient does not agree for follow-up during 6 months
- patient has an obvious causal lesion on MRI scan
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epilog Preop
patients receive Epilog preop analysis
|
automated analysis of surface EEG with electrocal source imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantification of Epilog+ driven changes of management plan
Time Frame: up to 6 months after recruitment
|
Descriptive analysis of population with results from Epilog Preop analysis that changed initial clinical decision (total number of patients, type management plan modification)
|
up to 6 months after recruitment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of Epilog+ compared to resection zone
Time Frame: up to 24 months after recruitment
|
Are Epilog+ results in the same location as the resection zone?
|
up to 24 months after recruitment
|
Sensitivity and specificity of Epilog+ compared to pathology
Time Frame: up to 24 months after recruitment
|
Are Epilog+ results identifying abnormal cortex?
|
up to 24 months after recruitment
|
Sensitivity and specificity of Epilog+ compared to seizure outcome
Time Frame: up to 24 months after recruitment
|
What proportion of patients are seizure free if Epilog+ results are resected; what proportion of patients are not seizure free if Epilog + results are not resected?
|
up to 24 months after recruitment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
added value of high density EEG + Epilog PreOp
Time Frame: up to 24 months after recruitment
|
Are results obtained with Epilog Preop from high density EEG better?
|
up to 24 months after recruitment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/26SEP/355
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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