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Clinical Utility of ESI in Presurgical Evaluation of Patients With Epilepsy (CUESIPE)

Primary Purpose

Electroencephalography, Refractory Epilepsy, Brain Imaging

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low-density ESI (LD ESI)
High-density ESI (HD ESI)
No electrical source imaging (ESI)
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Electroencephalography focused on measuring Electrical source imaging

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Drug resistant epilepsy
  • Potential candidates for epilepsy surgery

Exclusion Criteria:

  • Can not cooperate for EEG recording

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

No electrical source imaging (ESI)

Low-density ESI (LD ESI)

High-density ESI (HD ESI)

Arm Description

In all patients, the multidisciplinary epilepsy surgery team will make a conclusion on management plan, based on all non-invasive presurgical data, except for ESI.

The multidisciplinary epilepsy surgery team will make a conclusion on management plan, based on all non-invasive presurgical data, including ESI using LD EEG recordings.

The multidisciplinary epilepsy surgery team will make a conclusion on management plan, based on all non-invasive presurgical data, including ESI using HD EEG recordings.

Outcomes

Primary Outcome Measures

Clinical utility of LD ESI and of HD ESI: change in clinical decision following ESI
Defined as the proportion of patients in whom the patient management plan was changed, based on the LD ESI and respectively HD ESI

Secondary Outcome Measures

Change to stop
The patient is not offered surgery.
Change from stop to implantation of intracranial electrodes
Without ESI the patient is not offered surgery. Based on ESI, implantation of intracranial recordings is offered.
Change in the strategy (location) of implanted intracranial electrodes
Additional intracranial electrodes are implanted, based on the results of ESI.
Change from stop to operation
Without ESI, the patient is not offered operation. Based on ESI, operation is offered.
Change from implantation of intracranial electrodes to operation
Without ESI, implantation of intracranial electrodes is offered. Based on ESI, operation is offered.
Change from operation to implantation of intracranial electrodes
Without ESI, operation is offered. Based on ESI this is changed to implantation of intracranial electrodes.

Full Information

First Posted
April 26, 2018
Last Updated
March 26, 2019
Sponsor
Rigshospitalet, Denmark
Collaborators
Filadelfia Epilepsy Hospital, Lundbeck Foundation, Lennart Grams Mindefond, Danish Epilepsy Society
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1. Study Identification

Unique Protocol Identification Number
NCT03533530
Brief Title
Clinical Utility of ESI in Presurgical Evaluation of Patients With Epilepsy
Acronym
CUESIPE
Official Title
Electrical Source Imaging in Presurgical Evaluation of Patients With Focal Epilepsy: A Prospective Study of Clinical Utility
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2, 2015 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Filadelfia Epilepsy Hospital, Lundbeck Foundation, Lennart Grams Mindefond, Danish Epilepsy Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates to what extend electrical source imaging (ESI) provides nonredundant information in the evaluation of epilepsy surgery candidates. Epilepsy surgery normally requires an extensive multimodal workup to identify the epileptic focus. This workup includes Magnetic Resonance Imaging (MRI), electroencephalography (EEG) without source imaging, video monitoring and when needed Positron Emission Tomography (PET), Magnetoencephalography (MEG), Single Photon Emission Computed Tomography (SPECT) and invasive EEG recordings using implanted electrodes. ESI estimates the location of the epileptic source with a high sensitivity and specificity using inverse source estimation methods on non-invasive EEG recordings. This study aims to investigate the clinical utility of ESI using low-density (LD, 25 channels) and high-density (HD, 256 channels) EEG. Clinical utility is defined in this study as the proportion of patients in whom the patient management plan was changed, based on the results of ESI. Should ESI be added to the routine work-up of epilepsy surgery candidates.
Detailed Description
Patients with drug resistant epilepsy can be offered resective neurosurgery if seizure semiology, video-EEG and MRI points to a focal origin in the brain. Are these investigations not concordant or is the MRI without a lesion, then additional investigations such as PET, SPECT and MEG can be performed before deciding upon operation or further, invasive investigation, using intracranial EEG recordings. If a single hypothesis can be made the patient can be operated. In case of one main hypothesis and additional hypothesis, intracranial EEG registration can be performed. If there are no hypothesis or too many hypotheses the patient cannot be offered surgery. In the present study electrical source imaging (ESI) will be performed in epilepsy surgery candidates on low density (LD, 25 channels) and high density (HD, 256 channels) electroencephalography (EEG). In the analysis of LD-EEG, a template brain and template electrode position will be used. In the analysis of HD-EEG an individual MRI scan and individual electrode position will be used. The multidisciplinary epilepsy surgery team will be blinded to the results of the ESI, until based on MRI, LD EEG (without source imaging), video monitoring and optionally PET, MEG and ictal-SPECT, the investigators have decided whether a patient 1) is ready for surgery, 2) should be evaluated with intracranial electrodes or 3) cannot be offered operation. This decision is registered. Then LD ESI is presented. It is registered whether any change in the patient management plan was made, based on the ESI data. Further, for 1) it is registered whether the planned extend of the surgical resection is changed and whether intraoperative EEG recording is needed; for 2) it is registered if the planned implantation strategy of intracranial electrodes is changed; and for 3) whether other additional evaluation is needed. Finally, HD ESI is presented and it is registered if this changes the decision made without ESI, according to the above-mentioned categories. Clinical utility of LD ESI and of HD ESI is defined as the proportion of patients in whom the patient management plan was changed, based on the LD ESI and respectively HD ESI. The investigators will use McNemar test to compare the proportion of changes based on LD ESI with those based on HD ESI. The localization provided by the ESI methods, will be compared with the conclusion of the multidisciplinary team, on the localization of the epileptic focus. In patients having intracranial EEG performed within the study period, the results will be compared to the ESI results. In patients having one-year follow-up after operation and being seizure free, it will be evaluated if the location of the ESI was within the operation area.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electroencephalography, Refractory Epilepsy, Brain Imaging, Surgery
Keywords
Electrical source imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Evaluation of low-density (LD, 25 channels) and high-density (HD, 256 channels) electrical source imaging (ESI) in epilepsy surgery
Masking
Outcomes Assessor
Masking Description
The Epilepsy Surgery Group make their decision about the surgical approach only with knowledge of the LD-EEG without ESI (and knowledge of non EEG investigations). Thereafter the LD ESI results are revealed and the clinical decision is revised. Finally the HD ESI results are revealed and the clinical decision is revised.
Allocation
Non-Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No electrical source imaging (ESI)
Arm Type
Active Comparator
Arm Description
In all patients, the multidisciplinary epilepsy surgery team will make a conclusion on management plan, based on all non-invasive presurgical data, except for ESI.
Arm Title
Low-density ESI (LD ESI)
Arm Type
Experimental
Arm Description
The multidisciplinary epilepsy surgery team will make a conclusion on management plan, based on all non-invasive presurgical data, including ESI using LD EEG recordings.
Arm Title
High-density ESI (HD ESI)
Arm Type
Experimental
Arm Description
The multidisciplinary epilepsy surgery team will make a conclusion on management plan, based on all non-invasive presurgical data, including ESI using HD EEG recordings.
Intervention Type
Diagnostic Test
Intervention Name(s)
Low-density ESI (LD ESI)
Intervention Description
Electrical source imaging using low density EEG
Intervention Type
Diagnostic Test
Intervention Name(s)
High-density ESI (HD ESI)
Intervention Description
Electrical source imaging using high density EEG
Intervention Type
Diagnostic Test
Intervention Name(s)
No electrical source imaging (ESI)
Intervention Description
For all patients: MRI, semiology, visual interpretation of EEG. When needed: PET, SPECT.
Primary Outcome Measure Information:
Title
Clinical utility of LD ESI and of HD ESI: change in clinical decision following ESI
Description
Defined as the proportion of patients in whom the patient management plan was changed, based on the LD ESI and respectively HD ESI
Time Frame
Through study completion - an average 1 year - at the end of the presurgical work-up of each patient, at the multidisciplinary epilepsy surgery meeting. The timeframe of completing the presurgical evaluation varies from 6 months to 24 month.
Secondary Outcome Measure Information:
Title
Change to stop
Description
The patient is not offered surgery.
Time Frame
Through study completion - an average 1 year - at the end of the presurgical work-up of each patient, at the multidisciplinary epilepsy surgery meeting. The timeframe of completing the presurgical evaluation varies from 6 months to 24 month.
Title
Change from stop to implantation of intracranial electrodes
Description
Without ESI the patient is not offered surgery. Based on ESI, implantation of intracranial recordings is offered.
Time Frame
Through study completion - an average 1 year - at the end of the presurgical work-up of each patient, at the multidisciplinary epilepsy surgery meeting. The timeframe of completing the presurgical evaluation varies from 6 months to 24 month.
Title
Change in the strategy (location) of implanted intracranial electrodes
Description
Additional intracranial electrodes are implanted, based on the results of ESI.
Time Frame
Through study completion - an average 1 year - at the end of the presurgical work-up of each patient, at the multidisciplinary epilepsy surgery meeting. The timeframe of completing the presurgical evaluation varies from 6 months to 24 month.
Title
Change from stop to operation
Description
Without ESI, the patient is not offered operation. Based on ESI, operation is offered.
Time Frame
Through study completion - an average 1 year - at the end of the presurgical work-up of each patient, at the multidisciplinary epilepsy surgery meeting. The timeframe of completing the presurgical evaluation varies from 6 months to 24 month.
Title
Change from implantation of intracranial electrodes to operation
Description
Without ESI, implantation of intracranial electrodes is offered. Based on ESI, operation is offered.
Time Frame
Through study completion - an average 1 year - at the end of the presurgical work-up of each patient, at the multidisciplinary epilepsy surgery meeting. The timeframe of completing the presurgical evaluation varies from 6 months to 24 month.
Title
Change from operation to implantation of intracranial electrodes
Description
Without ESI, operation is offered. Based on ESI this is changed to implantation of intracranial electrodes.
Time Frame
Through study completion - an average 1 year - at the end of the presurgical work-up of each patient, at the multidisciplinary epilepsy surgery meeting. The timeframe of completing the presurgical evaluation varies from 6 months to 24 month.
Other Pre-specified Outcome Measures:
Title
The localization provided by the ESI methods, will be compared with results of the intracranial recordings and the operation outcome (where available)
Description
Comparison at sublobar level between the ESI and the conclusion of the multidisciplinary team.
Time Frame
An average 1 year - at follow-up of the intracranial results and following the operation. The timeframe for follow-up varies from 6 months to 18 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Drug resistant epilepsy Potential candidates for epilepsy surgery Exclusion Criteria: Can not cooperate for EEG recording
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olaf B Paulson, MD, DMSc
Organizational Affiliation
Rigshospitalet, N-6931
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Select
ZIP/Postal Code
DK-2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Utility of ESI in Presurgical Evaluation of Patients With Epilepsy

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