EpilepsySEMAINENCT02342938
Simultaneous MEG or fMRI And INtracranial EEG
A study testing MEG or fMRI And INtracranial EEG and fMRI in people with Epilepsy and Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The SEMAINE project will investigate intracranial EEG (icEEG) simultaneously recorded with either fMRI or MEG to 1) improve identification of the epileptogenic zone in patients suffering from drug-resistant partial epilepsy, and 2) define the functional organization of neural networks underlying human perception and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Healthy Volunteers
- What is being tested?
- MEG or fMRI And INtracranial EEG and fMRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2013to 18 May 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged between 18 and 60 years, not subject of any measure of legal protection
- Patients suffering from drug resistant partial epilepsy
- Patient undergoing intracranial video EEG
- Patients with electrodes implanted in orthogonal
- no MRI cons-indication
- Patients who signed a consent form
- Intellectual capacity to perform cognitive tasks and to sign an informed consent.
- Affiliation to social security
Who cannot join
- Pregnant women
- Elderly patients under 18 or over 60 years Patient not suffering from drug resistant partial epilepsy, or not scheduled for a SEEG
- MRI cons-indication
- Patients taking psychotropics drugs
- Claustrophobia
- Inability to perform cognitive tasks or to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The SEMAINE project will investigate intracranial EEG (icEEG) simultaneously recorded with either fMRI or MEG to 1) improve identification of the epileptogenic zone in patients suffering from drug-resistant partial epilepsy, and 2) define the functional organization of neural networks underlying human perception and cognition in order to prevent inadvertent deficits resulting from neurosurgical resection. In particular, high-frequency activity (HFA), as measured with icEEG, has been demonstrated in recent years as a relevant index for both epileptogenic tissue and healthy cortical processing, but its correlates in fMRI and MEG require further investigation. This will be a pioneering effort in several respects, as the first to directly measure high-frequency neural activity in tandem with fMRI, and among the first to do so with MEG. In addition to their attractiveness as noninvasive imaging techniques, fMRI and MEG have the potential to examine whole-brain networks that are not accessible to icEEG's necessarily limited spatial coverage. Furthermore, such a campaign of simultaneous recordings will take unprecedented advantage of icEEG as the bridge between the two noninvasive techniques, providing compelling evidence for the links between all three measurements with respect to underlying high-frequency neural activity in both health and disease. This project will therefore lead to improved selection of epilepsy surgery candidates and improved neurosurgical outcomes from the precise mapping of epileptogenic and healthy brain networks. The same techniques will be immediately applicable to functional mapping of other types of neurosurgery populations as well as diagnostic neuroimaging of neurological and psychiatric populations.
- Conditions
- Epilepsy, Healthy Volunteers
- Being tested
- MEG or fMRI And INtracranial EEG, fMRI
- Keywords
- Epilepsy surgery, High frequency activity, icEEG, fMRI, MEG
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEG or fMRI And INtracranial EEGProcedure or surgery
fMRIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Not described Receives: Procedure: fMRI |
| Volunteers | Experimental | Not described Receives: Procedure: MEG or fMRI And INtracranial EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygenation Level Dependent changes, associated with intracranial EEG signal, as determined by simultaneous fMRI and icEEG
fMRI correlates of epileptic and cognitive-induced high-frequency activities
Measured: Month 2
MEG signal, associated with intracranial EEG signal, as determined by simultaneous MEG and icEEG
MEG correlates of epileptic and cognitive-induced high-frequency activities
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study start16 Sep 2013
- Primary completion18 May 2017
- Study completion18 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Konstanz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342938
- Sponsor's protocol ID
- 2011.698
- Acronym
- SEMAINE
- Status last verified
- Aug 2025
- First submitted
- 6 Oct 2014
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Saignavongs M, Ciumas C, Petton M, Bouet R, Boulogne S, Rheims S, Carmichael DW, Lachaux JP, Ryvlin P. Neural Activity Elicited by a Cognitive Task can be Detected in Single-Trials with Simultaneous Intracerebral EEG-fMRI Recordings. Int J Neural Syst. 2017 Feb;27(1):1750001. doi: 10.1142/S0129065717500010. Epub 2016 Aug 22.
PubMed 27718767
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous MEG or fMRI And INtracranial EEG
- ClinicalTrials.gov ID
- NCT02342938
- Acronym / sponsor ID
- SEMAINE / 2011.698
- Conditions
- Epilepsy, Healthy Volunteers
- Keywords
- Epilepsy surgery, High frequency activity, icEEG, fMRI, MEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- University of Konstanz
- Study start
- 16 Sep 2013 (actual)
- Primary completion
- 18 May 2017 (actual)
- Study completion
- 18 May 2017 (actual)
- First posted
- 21 Jan 2015 (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.
The SEMAINE project will investigate intracranial EEG (icEEG) simultaneously recorded with either fMRI or MEG to 1) improve identification of the epileptogenic zone in patients suffering from drug-resistant partial epilepsy, and 2) define the functional organization of neural networks underlying human perception and cognition in order to prevent inadvertent deficits resulting from neurosurgical resection. In particular, high-frequency activity (HFA), as measured with icEEG, has been demonstrated in recent years as a relevant index for both epileptogenic tissue and healthy cortical processing, but its correlates in fMRI and MEG require further investigation. This will be a pioneering effort in several respects, as the first to directly measure high-frequency neural activity in tandem with fMRI, and among the first to do so with MEG. In addition to their attractiveness as noninvasive imaging techniques, fMRI and MEG have the potential to examine whole-brain networks that are not accessible to icEEG's necessarily limited spatial coverage. Furthermore, such a campaign of simultaneous recordings will take unprecedented advantage of icEEG as the bridge between the two noninvasive techniques, providing compelling evidence for the links between all three measurements with respect to underlying high-frequency neural activity in both health and disease. This project will therefore lead to improved selection of epilepsy surgery candidates and improved neurosurgical outcomes from the precise mapping of epileptogenic and healthy brain networks. The same techniques will be immediately applicable to functional mapping of other types of neurosurgery populations as well as diagnostic neuroimaging of neurological and psychiatric populations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Procedure: fMRI |
| Volunteers | Experimental | Procedure: MEG or fMRI And INtracranial EEG |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients aged between 18 and 60 years, not subject of any measure of legal protection
- Patients suffering from drug resistant partial epilepsy
- Patient undergoing intracranial video EEG
- Patients with electrodes implanted in orthogonal
- no MRI cons-indication
Key exclusion criteria (6 listed)
- Pregnant women
- Elderly patients under 18 or over 60 years Patient not suffering from drug resistant partial epilepsy, or not scheduled for a SEEG
- MRI cons-indication
- Patients taking psychotropics drugs
- Claustrophobia
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 |
|---|---|---|
| MEG or fMRI And INtracranial EEG | Procedure or surgery | Volunteers |
| fMRI | Procedure or surgery | Patient |
Primary outcome
Blood Oxygenation Level Dependent changes, associated with intracranial EEG signal, as determined by simultaneous fMRI and icEEG
Time frame: Month 2
fMRI correlates of epileptic and cognitive-induced high-frequency activities
MEG signal, associated with intracranial EEG signal, as determined by simultaneous MEG and icEEG
Time frame: Month 2
MEG correlates of epileptic and cognitive-induced high-frequency activities
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 4 Sep 2025.
- Results publication: PubMed 27718767Saignavongs M, Ciumas C, Petton M, Bouet R, Boulogne S, Rheims S, Carmichael DW, Lachaux JP, Ryvlin P. Neural Activity Elicited by a Cognitive Task can be Detected in Single-Trials with Simultaneous Intracerebral EEG-fMRI Recordings. Int J Neural Syst. 2017 Feb;27(1):1750001. doi: 10.1142/S0129065717500010. Epub 2016 Aug 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEG or fMRI And INtracranial EEG and fMRI in people with Epilepsy and Healthy Volunteers, run by Hospices Civils de Lyon 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 8 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 4 Sep 2025. 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?
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?
Blood Oxygenation Level Dependent changes, associated with intracranial EEG signal, as determined by simultaneous fMRI and icEEG (time frame: Month 2). The study lists 2 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 NCT02342938, which also lists 1 linked publication.
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 4 Sep 2025.