Clinical Utility of ESI in Presurgical Evaluation of Patients With Epilepsy

NCT03533530 | Completed

• 1 other identifier: LD&HD-ESI
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Electroencephalography; Refractory Epilepsy; Brain Imaging; Surgery

Keywords

Electrical source imaging

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (6)

• Change to stop

  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.

• Change from stop to implantation of intracranial electrodes

  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.

• Change in the strategy (location) of implanted intracranial electrodes

  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.

• Change from stop to operation

  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.

• Change from implantation of intracranial electrodes to operation

  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 Outcomes (1)

• The localization provided by the ESI methods, will be compared with results of the intracranial recordings and the operation outcome (where available)

  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.

Study Arms (3)

No electrical source imaging (ESI)

ACTIVE COMPARATOR

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.

Diagnostic Test: No electrical source imaging (ESI)

Low-density ESI (LD ESI)

EXPERIMENTAL

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.

Diagnostic Test: Low-density ESI (LD ESI)

High-density ESI (HD ESI)

EXPERIMENTAL

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.

Diagnostic Test: High-density ESI (HD ESI)

Interventions

Low-density ESI (LD ESI) DIAGNOSTIC_TEST

Electrical source imaging using low density EEG

Low-density ESI (LD ESI)

High-density ESI (HD ESI) DIAGNOSTIC_TEST

Electrical source imaging using high density EEG

High-density ESI (HD ESI)

No electrical source imaging (ESI) DIAGNOSTIC_TEST

For all patients: MRI, semiology, visual interpretation of EEG. When needed: PET, SPECT.

No electrical source imaging (ESI)

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Drug resistant epilepsy
• Potential candidates for epilepsy surgery

You may not qualify if:

• Can not cooperate for EEG recording

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Filadelfia Epilepsy Hospital: collaborator
• Lundbeck Foundation: collaborator
• Lennart Grams Mindefond, Danish Epilepsy Society: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Select, DK-2100, Denmark

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Olaf B Paulson, MD, DMSc

  Rigshospitalet, N-6931

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, DMSc

Model Details: Evaluation of low-density (LD, 25 channels) and high-density (HD, 256 channels) electrical source imaging (ESI) in epilepsy surgery

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 23, 2018
• Study Start: December 2, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)