NCT03882151

Brief Summary

Drug resistant epilepsy is best managed by surgery. The goal of presurgical evalution is to correctly identify the epileptogenic zone, defined by the extent of cortical tissue that needs to be removed is order to achieve seizure freedom. When no causative lesion is identified, careful study of interictal activity is mandatory. Complementary analysis methods exist, designed to identify the source of electrical activity recorded with surface electro-encephalogram. While results are interesting in retrospective studies, the real clinical added value needs to be demonstrated with prospective studies. The company Epilog (Epilog, Ghent, Belgium) offers, with EPILOG PreOp®, a long-term EEG analysis to automatically detect epileptiform activity, combined with an estimation of the electrical source localization using a sLORETA inverse solution model. We will propose the EPILOG PreOp analysis to refractory epileptic patients with non-contributive cerebral imaging, under presurgical evaluation. By comparing the therapeutic decision with and without knowledge of the results of EPILOG PreOp®, we will establish the added clinical value of EPILOG PreOp®.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

1.4 years

First QC Date

March 6, 2019

Last Update Submit

March 18, 2019

Conditions

Epilepsies, Partial

Keywords

epilepsydrug resistant epilepsyelectrical source imagingsurgery

Outcome Measures

Primary Outcomes (1)

  • Quantification of Epilog+ driven changes of management plan

    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 Outcomes (3)

  • Sensitivity and specificity of Epilog+ compared to resection zone

    up to 24 months after recruitment

  • Sensitivity and specificity of Epilog+ compared to pathology

    up to 24 months after recruitment

  • Sensitivity and specificity of Epilog+ compared to seizure outcome

    up to 24 months after recruitment

Other Outcomes (1)

  • added value of high density EEG + Epilog PreOp

    up to 24 months after recruitment

Study Arms (1)

Epilog Preop

EXPERIMENTAL

patients receive Epilog preop analysis

Diagnostic Test: electrical source imaging

Interventions

electrical source imagingDIAGNOSTIC_TEST

automated analysis of surface EEG with electrocal source imaging

Epilog Preop

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • drug resistant epilepsy under presurgical evaluation
  • non lesional 3Tesla MRI scan
  • epileptic seizure(s) recorded during video-EEG monitoring

You may not qualify if:

  • patient does not agree for follow-up during 6 months
  • patient has an obvious causal lesion on MRI scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint-Luc University Hospital

Brussels, 1200, Belgium

RECRUITING

Centre Hospitalier William Lennox

Ottignies, 1340, Belgium

RECRUITING

MeSH Terms

Conditions

Epilepsies, PartialEpilepsyDrug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Susana Ferrao Santos, MD, PhD

CONTACT

027647801susana.ferrao@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Investigator has no access to Epilog Preop result during first case description.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: All patients included will have Epilog Preop analysis
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 20, 2019

Study Start

January 15, 2019

Primary Completion

June 1, 2020

Study Completion

December 31, 2020

Last Updated

March 20, 2019

Record last verified: 2019-03

Locations

BE(2)