ElectroencephalographyCUESIPENCT03533530
Clinical Utility of ESI in Presurgical Evaluation of Patients With Epilepsy
A study testing Low-density ESI (LD ESI), High-density ESI (HD ESI) and No electrical source imaging (ESI) in people with Electroencephalography and Refractory Epilepsy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Electroencephalography, Refractory Epilepsy, Brain Imaging
- What is being tested?
- Low-density ESI (LD ESI), High-density ESI (HD ESI) and No electrical source imaging (ESI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Dec 2015to 1 Nov 2018
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Drug resistant epilepsy
- Potential candidates for epilepsy surgery
Who cannot join
- Can not cooperate for EEG recording
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Source Imaging in Presurgical Evaluation of Patients With Focal Epilepsy: A Prospective Study of Clinical Utility
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.
Read the 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.
- Conditions
- Electroencephalography, Refractory Epilepsy, Brain Imaging, Surgery
- Being tested
- Low-density ESI (LD ESI), High-density ESI (HD ESI), No electrical source imaging (ESI)
- Keywords
- Electrical source imaging
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-density ESI (LD ESI)Diagnostic test
Electrical source imaging using low density EEG
High-density ESI (HD ESI)Diagnostic test
Electrical source imaging using high density EEG
No electrical source imaging (ESI)Diagnostic test
For all patients: MRI, semiology, visual interpretation of EEG. When needed: PET, SPECT.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: High-density ESI (HD ESI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The patient is not offered surgery.
Measured: 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
Without ESI the patient is not offered surgery. Based on ESI, implantation of intracranial recordings is offered.
Measured: 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
Additional intracranial electrodes are implanted, based on the results of ESI.
Measured: 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
Without ESI, the patient is not offered operation. Based on ESI, operation is offered.
Measured: 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
Without ESI, implantation of intracranial electrodes is offered. Based on ESI, operation is offered.
Measured: 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 operation to implantation of intracranial electrodes
Without ESI, operation is offered. Based on ESI this is changed to implantation of intracranial electrodes.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start2 Dec 2015
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroencephalographyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 low-density (LD, 25 channels) and high-density (HD, 256 channels) electrical source imaging (ESI) in epilepsy surgery
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Filadelfia Epilepsy Hospital, Lundbeck Foundation, Lennart Grams Mindefond, Danish Epilepsy Society
- Responsible party
- Principal investigator, Olaf B Paulson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Olaf B Paulson, MD, DMSc, Principal investigator, Rigshospitalet, N-6931
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533530
- Sponsor's protocol ID
- LD&HD-ESI
- Acronym
- CUESIPE
- Status last verified
- Mar 2019
- First submitted
- 26 Apr 2018
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Source Imaging in Presurgical Evaluation of Patients With Focal Epilepsy: A Prospective Study of Clinical Utility
- ClinicalTrials.gov ID
- NCT03533530
- Acronym / sponsor ID
- CUESIPE / LD&HD-ESI
- Conditions
- Electroencephalography, Refractory Epilepsy, Brain Imaging, Surgery
- Keywords
- Electrical source imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Filadelfia Epilepsy Hospital, Lundbeck Foundation, Lennart Grams Mindefond, Danish Epilepsy Society
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 23 May 2018 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Evaluation of low-density (LD, 25 channels) and high-density (HD, 256 channels) electrical source imaging (ESI) in epilepsy surgery
| Arm | Type | Receives |
|---|---|---|
| No electrical source imaging (ESI) | Active comparator | Diagnostic Test: No electrical source imaging (ESI)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. |
| Low-density ESI (LD ESI) | Experimental | Diagnostic Test: Low-density ESI (LD 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. |
| High-density ESI (HD ESI) | Experimental | Diagnostic Test: High-density ESI (HD ESI)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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Drug resistant epilepsy
- Potential candidates for epilepsy surgery
Key exclusion criteria (1 listed)
- Can not cooperate for EEG recording
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 |
|---|---|---|
| Low-density ESI (LD ESI)Electrical source imaging using low density EEG | Diagnostic test | Low-density ESI (LD ESI) |
| High-density ESI (HD ESI)Electrical source imaging using high density EEG | Diagnostic test | High-density ESI (HD ESI) |
| No electrical source imaging (ESI)For all patients: MRI, semiology, visual interpretation of EEG. When needed: PET, SPECT. | Diagnostic test | No electrical source imaging (ESI) |
Primary outcome
Clinical utility of LD ESI and of HD ESI: change in clinical decision following 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.
Defined as the proportion of patients in whom the patient management plan was changed, based on the LD ESI and respectively HD ESI
6 secondary outcomes
Change to stop
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.
Change from stop 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.
Change in the strategy (location) of implanted 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.
Change from stop to operation
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.
Change from implantation of intracranial electrodes to operation
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.
Change from operation 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Olaf B Paulson, MD, DMSc principal investigator
Rigshospitalet, N-6931
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-density ESI (LD ESI), High-density ESI (HD ESI) and No electrical source imaging (ESI) in people with Electroencephalography and Refractory Epilepsy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 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: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical utility of LD ESI and of HD ESI: change in clinical decision following 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2019.