EpilepsyEPISTIMNCT02844374
Epileptogenic Zone's Cartography by Quantification of EEG's Signal and Intracerebral Stimulation.
A study testing Functional stereotaxic exploration in people with Epilepsy, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Epilepsy is a devastating chronic disease due to multiple causes that affect close to 50% of the world's population. Although effective, epilepsy surgery fails in many cases, the percentage of patients free from crisis on a long term (≥ 5 years) varies from 27% to 66% according to the kind of epilepsy. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Functional stereotaxic exploration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jan 2017
- 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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient from 5 to 65 years (L1121-7 L1122 2 CSP), including legally protected or unable to give his consent (L1121-8 CSP).
- Written approval of inclusion in the study from the patient or his legal representative.
- Patients with partial Epilepsy Drug Resistant , justifying a SEEG exploration.
Who cannot join
- Patient under 5 years.
- Patient over 65 years.
- Pregnant or breastfeeeding women (L1121-5 CSP).
- Patient deprived of liberty as a result of a judicial or administrative decision (L1121-6 CSP).
- Patients over 18 years unable to give their free consent and not subject to a legal protection order.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UniversityHospitalGrenoble
La Tronche, 38700
Philippe Kahane, Professor, 04.76.76.54.48, philippe.kahane@ujf-grenoble.fr
Lorella Minotti, 0476765448, Lminotti@chu-grenoble.fr
About this study
Epilepsy is a devastating chronic disease due to multiple causes that affect close to 50% of the world's population.
Although effective, epilepsy surgery fails in many cases, the percentage of patients free from crisis on a long term (≥ 5 years) varies from 27% to 66% according to the kind of epilepsy.
It is in this context that EPISTIM is interesting, and its aims isb a better electrophysiology delimiting of cortical networks that imply the genesis of seizures with the aim to improove surgery results.
This study will rely on the intracerebral records and on corticales electrical stimulation as they are currently routinely used by epileptic patients candidates for surgery.
- Conditions
- Epilepsy
- Being tested
- Functional stereotaxic exploration
- Keywords
- Epilepsy, Surgery candidate, EEG's Signal
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional stereotaxic explorationOther
Also called sEEG
Visual analysis : in order to define the level of cortical resections. Epileptogenic maps : calculated for each crisis and for all crisis in general. Connectivity maps : calculated for each site stimulated at low-frequency. Post-operative evaluation : in order to assess the extent of resection.
| Study group | Role | What they receive |
|---|---|---|
| Partial Epilepsy Drug Resistant | Other | Patients with partial Epilepsy Drug Resistant , justifying a SEEG exploration. Receives: Other: Functional stereotaxic exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analysis
Visual analysis : in order to define the level of cortical resections.
Measured: up to one hour
Epileptogenic maps
Epileptogenic maps : calculated for each crisis and for all crisis in general.
Measured: up to 10 min
Connectivity maps
Connectivity maps : calculated for each site stimulated at low-frequency.
Measured: up to 10 min
MRI
Post-operative evaluation : in order to assess the extent of resection. MRI : 3D-T1
Measured: up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Kahane, Professor, Principal investigator, Grenoble Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844374
- Sponsor's protocol ID
- 38RC14.079
- Acronym
- EPISTIM
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Alarcon G, Binnie CD, Elwes RD, Polkey CE. Power spectrum and intracranial EEG patterns at seizure onset in partial epilepsy. Electroencephalogr Clin Neurophysiol. 1995 May;94(5):326-37. doi: 10.1016/0013-4694(94)00286-t.
PubMed 7774519Allen PJ, Fish DR, Smith SJ. Very high-frequency rhythmic activity during SEEG suppression in frontal lobe epilepsy. Electroencephalogr Clin Neurophysiol. 1992 Feb;82(2):155-9. doi: 10.1016/0013-4694(92)90160-j.
PubMed 1370786Bartolomei F, Chauvel P, Wendling F. Epileptogenicity of brain structures in human temporal lobe epilepsy: a quantified study from intracerebral EEG. Brain. 2008 Jul;131(Pt 7):1818-30. doi: 10.1093/brain/awn111. Epub 2008 Jun 13.
PubMed 18556663Blauwblomme T, Kahane P, Minotti L, Grouiller F, Krainik A, Vercueil L, Chabardes S, Hoffmann D, David O. Multimodal imaging reveals the role of gamma activity in eating-reflex seizures. J Neurol Neurosurg Psychiatry. 2011 Oct;82(10):1171-3. doi: 10.1136/jnnp.2010.212696. Epub 2010 Nov 19.
PubMed 21097547Bulacio JC, Jehi L, Wong C, Gonzalez-Martinez J, Kotagal P, Nair D, Najm I, Bingaman W. Long-term seizure outcome after resective surgery in patients evaluated with intracranial electrodes. Epilepsia. 2012 Oct;53(10):1722-30. doi: 10.1111/j.1528-1167.2012.03633.x. Epub 2012 Aug 20.
PubMed 22905787Cossu M, Cardinale F, Castana L, Citterio A, Francione S, Tassi L, Benabid AL, Lo Russo G. Stereoelectroencephalography in the presurgical evaluation of focal epilepsy: a retrospective analysis of 215 procedures. Neurosurgery. 2005 Oct;57(4):706-18; discussion 706-18.
PubMed 16239883Catenoix H, Magnin M, Guenot M, Isnard J, Mauguiere F, Ryvlin P. Hippocampal-orbitofrontal connectivity in human: an electrical stimulation study. Clin Neurophysiol. 2005 Aug;116(8):1779-84. doi: 10.1016/j.clinph.2005.03.016.
PubMed 16002335Catenoix H, Magnin M, Mauguiere F, Ryvlin P. Evoked potential study of hippocampal efferent projections in the human brain. Clin Neurophysiol. 2011 Dec;122(12):2488-97. doi: 10.1016/j.clinph.2011.05.007. Epub 2011 Jun 12.
PubMed 21669549David O, Bastin J, Chabardes S, Minotti L, Kahane P. Studying network mechanisms using intracranial stimulation in epileptic patients. Front Syst Neurosci. 2010 Oct 20;4:148. doi: 10.3389/fnsys.2010.00148. eCollection 2010.
PubMed 21060722David O, Blauwblomme T, Job AS, Chabardes S, Hoffmann D, Minotti L, Kahane P. Imaging the seizure onset zone with stereo-electroencephalography. Brain. 2011 Oct;134(Pt 10):2898-911. doi: 10.1093/brain/awr238.
PubMed 21975587Engel J Jr, Van Ness Paul C, Rasmussen TB, Ojemann LM. Outcome with respect to epileptic seizures. In: Engel J Jr, editor. Surgical treatment of the epilepsies, 2d ed. Philadelphia: Lippincott-Raven; 1996: 609-621.
Fisher RS, Webber WR, Lesser RP, Arroyo S, Uematsu S. High-frequency EEG activity at the start of seizures. J Clin Neurophysiol. 1992 Jul;9(3):441-8. doi: 10.1097/00004691-199207010-00012.
PubMed 1517412Gordon B, Lesser RP, Rance NE, Hart J Jr, Webber R, Uematsu S, Fisher RS. Parameters for direct cortical electrical stimulation in the human: histopathologic confirmation. Electroencephalogr Clin Neurophysiol. 1990 May;75(5):371-7. doi: 10.1016/0013-4694(90)90082-u.
PubMed 1692272Jallon P. [Epidemiology of drug-resistant epilepsies]. Rev Neurol (Paris). 2004 Jun;160 Spec No 1:5S22-30. French.
PubMed 15331944Jirsch JD, Urrestarazu E, LeVan P, Olivier A, Dubeau F, Gotman J. High-frequency oscillations during human focal seizures. Brain. 2006 Jun;129(Pt 6):1593-608. doi: 10.1093/brain/awl085. Epub 2006 Apr 21.
PubMed 16632553
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epileptogenic Zone's Cartography by Quantification of EEG's Signal and Intracerebral Stimulation.
- ClinicalTrials.gov ID
- NCT02844374
- Acronym / sponsor ID
- EPISTIM / 38RC14.079
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Surgery candidate, EEG's Signal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 26 Jul 2016 (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.
Epilepsy is a devastating chronic disease due to multiple causes that affect close to 50% of the world's population.
Although effective, epilepsy surgery fails in many cases, the percentage of patients free from crisis on a long term (≥ 5 years) varies from 27% to 66% according to the kind of epilepsy.
It is in this context that EPISTIM is interesting, and its aims isb a better electrophysiology delimiting of cortical networks that imply the genesis of seizures with the aim to improove surgery results.
This study will rely on the intracerebral records and on corticales electrical stimulation as they are currently routinely used by epileptic patients candidates for surgery.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial Epilepsy Drug Resistant | Other | Other: Functional stereotaxic explorationPatients with partial Epilepsy Drug Resistant , justifying a SEEG exploration. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient from 5 to 65 years (L1121-7 L1122 2 CSP), including legally protected or unable to give his consent (L1121-8 CSP).
- Written approval of inclusion in the study from the patient or his legal representative.
- Patients with partial Epilepsy Drug Resistant , justifying a SEEG exploration.
Key exclusion criteria (5 listed)
- Patient under 5 years.
- Patient over 65 years.
- Pregnant or breastfeeeding women (L1121-5 CSP).
- Patient deprived of liberty as a result of a judicial or administrative decision (L1121-6 CSP).
- Patients over 18 years unable to give their free consent and not subject to a legal protection order.
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 |
|---|---|---|
| Functional stereotaxic explorationAlso: sEEGVisual analysis : in order to define the level of cortical resections. Epileptogenic maps : calculated for each crisis and for all crisis in general. Connectivity maps : calculated for each site stimulated at low-frequency. Post-operative evaluation : in order to assess the extent of resection. | Other | Partial Epilepsy Drug Resistant |
Primary outcome
Visual analysis
Time frame: up to one hour
Visual analysis : in order to define the level of cortical resections.
Epileptogenic maps
Time frame: up to 10 min
Epileptogenic maps : calculated for each crisis and for all crisis in general.
Connectivity maps
Time frame: up to 10 min
Connectivity maps : calculated for each site stimulated at low-frequency.
MRI
Time frame: up to one hour
Post-operative evaluation : in order to assess the extent of resection. MRI : 3D-T1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Background: PubMed 7774519Alarcon G, Binnie CD, Elwes RD, Polkey CE. Power spectrum and intracranial EEG patterns at seizure onset in partial epilepsy. Electroencephalogr Clin Neurophysiol. 1995 May;94(5):326-37. doi: 10.1016/0013-4694(94)00286-t.
- Background: PubMed 1370786Allen PJ, Fish DR, Smith SJ. Very high-frequency rhythmic activity during SEEG suppression in frontal lobe epilepsy. Electroencephalogr Clin Neurophysiol. 1992 Feb;82(2):155-9. doi: 10.1016/0013-4694(92)90160-j.
- Background: PubMed 18556663Bartolomei F, Chauvel P, Wendling F. Epileptogenicity of brain structures in human temporal lobe epilepsy: a quantified study from intracerebral EEG. Brain. 2008 Jul;131(Pt 7):1818-30. doi: 10.1093/brain/awn111. Epub 2008 Jun 13.
- Background: PubMed 21097547Blauwblomme T, Kahane P, Minotti L, Grouiller F, Krainik A, Vercueil L, Chabardes S, Hoffmann D, David O. Multimodal imaging reveals the role of gamma activity in eating-reflex seizures. J Neurol Neurosurg Psychiatry. 2011 Oct;82(10):1171-3. doi: 10.1136/jnnp.2010.212696. Epub 2010 Nov 19.
- Background: PubMed 22905787Bulacio JC, Jehi L, Wong C, Gonzalez-Martinez J, Kotagal P, Nair D, Najm I, Bingaman W. Long-term seizure outcome after resective surgery in patients evaluated with intracranial electrodes. Epilepsia. 2012 Oct;53(10):1722-30. doi: 10.1111/j.1528-1167.2012.03633.x. Epub 2012 Aug 20.
- Background: PubMed 16239883Cossu M, Cardinale F, Castana L, Citterio A, Francione S, Tassi L, Benabid AL, Lo Russo G. Stereoelectroencephalography in the presurgical evaluation of focal epilepsy: a retrospective analysis of 215 procedures. Neurosurgery. 2005 Oct;57(4):706-18; discussion 706-18.
- Background: PubMed 16002335Catenoix H, Magnin M, Guenot M, Isnard J, Mauguiere F, Ryvlin P. Hippocampal-orbitofrontal connectivity in human: an electrical stimulation study. Clin Neurophysiol. 2005 Aug;116(8):1779-84. doi: 10.1016/j.clinph.2005.03.016.
- Background: PubMed 21669549Catenoix H, Magnin M, Mauguiere F, Ryvlin P. Evoked potential study of hippocampal efferent projections in the human brain. Clin Neurophysiol. 2011 Dec;122(12):2488-97. doi: 10.1016/j.clinph.2011.05.007. Epub 2011 Jun 12.
- Background: PubMed 21060722David O, Bastin J, Chabardes S, Minotti L, Kahane P. Studying network mechanisms using intracranial stimulation in epileptic patients. Front Syst Neurosci. 2010 Oct 20;4:148. doi: 10.3389/fnsys.2010.00148. eCollection 2010.
- Background: PubMed 21975587David O, Blauwblomme T, Job AS, Chabardes S, Hoffmann D, Minotti L, Kahane P. Imaging the seizure onset zone with stereo-electroencephalography. Brain. 2011 Oct;134(Pt 10):2898-911. doi: 10.1093/brain/awr238.
- BackgroundEngel J Jr, Van Ness Paul C, Rasmussen TB, Ojemann LM. Outcome with respect to epileptic seizures. In: Engel J Jr, editor. Surgical treatment of the epilepsies, 2d ed. Philadelphia: Lippincott-Raven; 1996: 609-621.
- Background: PubMed 1517412Fisher RS, Webber WR, Lesser RP, Arroyo S, Uematsu S. High-frequency EEG activity at the start of seizures. J Clin Neurophysiol. 1992 Jul;9(3):441-8. doi: 10.1097/00004691-199207010-00012.
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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.
Philippe Kahane, Professor principal investigator
Grenoble Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional stereotaxic exploration in people with Epilepsy, run by University Hospital, Grenoble at 1 site 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Jul 2016. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Kahane, Professor (04.76.76.54.48, philippe.kahane@ujf-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analysis (time frame: up to one hour). The study lists 4 primary outcomes in all. 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 NCT02844374, which also lists 40 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 26 Jul 2016.