Partial EpilepsyEEG-HRNCT01090934
Localizing the Epileptogenic Zone With High Resolution Electroencephalography
A study testing High Resolution EEG and Stereo-electroencephalography in people with Partial Epilepsy, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
Multicenter prospective study comparing the diagnosis value of high-resolution EEG and depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Partial Epilepsy
- What is being tested?
- High Resolution EEG and Stereo-electroencephalography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2009to Nov 2013
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- medically intractable patial epilepsy confirmed by video-EEG recordings of epileptic seizures.
- Depth EEG (Stereo-EEG) required to delineate the epileptogenic zone and define the surgical procedure.
- full informed consent of the patient (or of his/ her legal representative)
- 15 year or older patient
Who cannot join
- contraindication to cortectomy
- contraindication to depth-EEG
- indication of epilepsy surgery without depth-EEG monitoring
- high grade glioma, arterio-veinous malformations
- pregnancy
- history of severe cardio-vascular event (coronaropathy, stroke)
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital of Marseille
Marseille, 13000
Central Hospital
Nancy, 54000
About this study
Official title: Etude de la Performance Diagnostique de l'EEG-Haute Résolution Sur la Localisation de la Zone épileptogène Pour le Traitement Chirurgical Des épilepsies Partielles Pharmaco-résistantes
Multicenter prospective study comparing the diagnosis value of high-resolution EEG and depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies.
- Conditions
- Partial Epilepsy
- Being tested
- High Resolution EEG, Stereo-electroencephalography
- Keywords
- Diagnosis, Partial Epilepsy
- Medical subject headings
- Epilepsies, Partial, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Resolution EEGDevice
Also called electrical source imaging
High Resolution EEG
Stereo-electroencephalographyDevice
Also called depth-electroencephalography
SEEG
| Study group | Role | What they receive |
|---|---|---|
| high resolution EEG | Experimental | Not described Receives: Device: High Resolution EEG |
| Stereo Electroencephalography | Active comparator | Not described Receives: Device: Stereo-electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of electrical source localization of inter-ictal and ictal discharges using high-Resolution EEG for localizing the epileptogenic zone (the stereo-electroencephalography will be the reference method)
results of electrical sources localization of inter-ictal and ictal discharges are compared to the epileptogenic zone defined by SEEG
Measured: 3 years
Secondary outcomes (2)
inter-observer reliability of electrical source localization of inter-ictal and ictal discharges for localizing the epileptogenic zone.
sources localization of inter-ictal and ictal discharges will be interpreted by two independant epileptologists, blinded to the results of stereo-EEG.
Measured: 3 years
sensitivity and specificity of high resolution EEG and electrical source imaging for surgical decision
decision of surgery and the limits of the cortectomy established with electrical source imaging will be compared to the decision of surgery and the limits of the cortectomy established with Stereo-electroencephalography.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Partial EpilepsyStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Marseille, CHU de Reims, Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Principal investigator, louis maillard, Central Hospital, Nancy, France
- Investigators
- Louis Maillard, MD, PhD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090934
- Sponsor's protocol ID
- 2009-A00574-53
- Acronym
- EEG-HR
- Status last verified
- Jan 2016
- First submitted
- 5 Feb 2010
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maillard L, Koessler L, Colnat-Coulbois S, Vignal JP, Louis-Dorr V, Marie PY, Vespignani H. Combined SEEG and source localisation study of temporal lobe schizencephaly and polymicrogyria. Clin Neurophysiol. 2009 Sep;120(9):1628-36. doi: 10.1016/j.clinph.2009.06.022. Epub 2009 Jul 24.
PubMed 19632148Koessler L, Benar C, Maillard L, Badier JM, Vignal JP, Bartolomei F, Chauvel P, Gavaret M. Source localization of ictal epileptic activity investigated by high resolution EEG and validated by SEEG. Neuroimage. 2010 Jun;51(2):642-53. doi: 10.1016/j.neuroimage.2010.02.067. Epub 2010 Mar 4.
PubMed 20206700Koessler L, Cecchin T, Caspary O, Benhadid A, Vespignani H, Maillard L. EEG-MRI co-registration and sensor labeling using a 3D laser scanner. Ann Biomed Eng. 2011 Mar;39(3):983-95. doi: 10.1007/s10439-010-0230-0. Epub 2010 Dec 8.
PubMed 21140291Koessler L, Salido-Ruiz R, Ranta R, Louis-Dorr V, Gavaret M, Maillard L. Influence of source separation and montage on ictal source localization. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:2898-901. doi: 10.1109/IEMBS.2010.5626321.
PubMed 21095980
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de la Performance Diagnostique de l'EEG-Haute Résolution Sur la Localisation de la Zone épileptogène Pour le Traitement Chirurgical Des épilepsies Partielles Pharmaco-résistantes
- ClinicalTrials.gov ID
- NCT01090934
- Acronym / sponsor ID
- EEG-HR / 2009-A00574-53
- Conditions
- Partial Epilepsy
- Keywords
- Diagnosis, Partial Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University Hospital, Marseille, CHU de Reims, Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Oct 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Mar 2010 (estimated)
- 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.
Multicenter prospective study comparing the diagnosis value of high-resolution EEG and depth-EEG to localize the epileptogenic zone in drug resistant partial epilepsies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high resolution EEG | Experimental | Device: High Resolution EEG |
| Stereo Electroencephalography | Active comparator | Device: Stereo-electroencephalography |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- medically intractable patial epilepsy confirmed by video-EEG recordings of epileptic seizures.
- Depth EEG (Stereo-EEG) required to delineate the epileptogenic zone and define the surgical procedure.
- full informed consent of the patient (or of his/ her legal representative)
- 15 year or older patient
Key exclusion criteria (6 listed)
- contraindication to cortectomy
- contraindication to depth-EEG
- indication of epilepsy surgery without depth-EEG monitoring
- high grade glioma, arterio-veinous malformations
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 |
|---|---|---|
| High Resolution EEGAlso: electrical source imagingHigh Resolution EEG | Device | high resolution EEG |
| Stereo-electroencephalographyAlso: depth-electroencephalographySEEG | Device | Stereo Electroencephalography |
Primary outcome
Sensitivity and specificity of electrical source localization of inter-ictal and ictal discharges using high-Resolution EEG for localizing the epileptogenic zone (the stereo-electroencephalography will be the reference method)
Time frame: 3 years
results of electrical sources localization of inter-ictal and ictal discharges are compared to the epileptogenic zone defined by SEEG
2 secondary outcomes
inter-observer reliability of electrical source localization of inter-ictal and ictal discharges for localizing the epileptogenic zone.
Time frame: 3 years
sensitivity and specificity of high resolution EEG and electrical source imaging for surgical decision
Time frame: 3 years
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 Jan 2016.
- Background: PubMed 19632148Maillard L, Koessler L, Colnat-Coulbois S, Vignal JP, Louis-Dorr V, Marie PY, Vespignani H. Combined SEEG and source localisation study of temporal lobe schizencephaly and polymicrogyria. Clin Neurophysiol. 2009 Sep;120(9):1628-36. doi: 10.1016/j.clinph.2009.06.022. Epub 2009 Jul 24.
- Background: PubMed 20206700Koessler L, Benar C, Maillard L, Badier JM, Vignal JP, Bartolomei F, Chauvel P, Gavaret M. Source localization of ictal epileptic activity investigated by high resolution EEG and validated by SEEG. Neuroimage. 2010 Jun;51(2):642-53. doi: 10.1016/j.neuroimage.2010.02.067. Epub 2010 Mar 4.
- Results publication: PubMed 21140291Koessler L, Cecchin T, Caspary O, Benhadid A, Vespignani H, Maillard L. EEG-MRI co-registration and sensor labeling using a 3D laser scanner. Ann Biomed Eng. 2011 Mar;39(3):983-95. doi: 10.1007/s10439-010-0230-0. Epub 2010 Dec 8.
- Results publication: PubMed 21095980Koessler L, Salido-Ruiz R, Ranta R, Louis-Dorr V, Gavaret M, Maillard L. Influence of source separation and montage on ictal source localization. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:2898-901. doi: 10.1109/IEMBS.2010.5626321.
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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.
Louis Maillard, MD, PhD principal investigator
Central Hospital, Nancy, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Resolution EEG and Stereo-electroencephalography in people with Partial Epilepsy, run by Central Hospital, Nancy, France at 2 sites in France.
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 4 inclusion and 6 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 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Sensitivity and specificity of electrical source localization of inter-ictal and ictal discharges using high-Resolution EEG for localizing the epileptogenic zone (the stereo-electroencephalography will be the reference method) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090934, which also lists 4 linked publications.
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 Jan 2016.