EpilepsiesNCT01313260
Structural and Functional Connectivity in Partial Epilepsies Studied with MRI and MEG
An observational study of Epilepsies, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Surgery may be an effective therapy for refractory focal epilepsies with a clear delineated focus but surgical benefits are less clear for patients with a poorly defined focus such as non lesional refractory partial epilepsies. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsies
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2011to Oct 2013
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Refractory partial epilepsy patients
Who may be able to join
- intracranial EEG recordings scheduled
- no neurological or psychiatric disease for healthy volunteers
Who cannot join
- contraindication to MRI
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Surgery may be an effective therapy for refractory focal epilepsies with a clear delineated focus but surgical benefits are less clear for patients with a poorly defined focus such as non lesional refractory partial epilepsies.
SEEG is considered the criterion standard to localize the epileptogenic zone (EZ) but the procedure is risky with a limited spatial sampling. The development of non-invasive neuroimaging alternatives is thus an important goal to improve EZ delineation and optimize SEEG procedures.
Read more
The main hypothesis of this research project is the existence of a network organization specific for each patient which allows the generation and propagation of epileptic activities. The investigators wish to explore this network using diffusion tensor MRI to study structural connectivity and MEG/FMRI to study functional connectivity. The investigators will apply tools from the theories of complex networks and dynamical systems to characterize the network organization of epileptic process.
The investigators aimed to identify and localize differences in connectivity parameters between individual patients and a control group of healthy volunteers.
- Conditions
- Epilepsies
- Keywords
- Refractory partial epilepsies
- Medical subject headings
- Epilepsy, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy patients | Epilepsy patients selected before undergoing intracranial EEG recordings | |
| control group | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epileptic network assessed using structural and functional connectivity measures obtained with MRI and MEG
Structural connectivity will be assessed using diffusion tensor MRI including the following parameters: mean diffusivity and anisotropy at voxel level, fiber tractography.
Functional connectivity will be assessed using Rs-FMRI or MEG signal correlation measures. Cortical parcellation will allow the location of connectivity parameters calculated using the graph theory.
Structural and functional data from one given patient will be statistically compared those of the control group.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study start5 Apr 2011
- Primary completionOct 2013
- Study completionOct 2013
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 EpilepsiesStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313260
- Sponsor's protocol ID
- C09-21
- Other IDs
- 2010-A00399-30
- Status last verified
- Jan 2025
- First submitted
- 15 Feb 2011
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chavez M, Valencia M, Navarro V, Latora V, Martinerie J. Functional modularity of background activities in normal and epileptic brain networks. Phys Rev Lett. 2010 Mar 19;104(11):118701. doi: 10.1103/PhysRevLett.104.118701. Epub 2010 Mar 18.
PubMed 20366507
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Connectivity in Partial Epilepsies Studied with MRI and MEG
- ClinicalTrials.gov ID
- NCT01313260
- Acronym / sponsor ID
- C09-21
- Conditions
- Epilepsies
- Keywords
- Refractory partial epilepsies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 5 Apr 2011 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Mar 2011 (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.
Surgery may be an effective therapy for refractory focal epilepsies with a clear delineated focus but surgical benefits are less clear for patients with a poorly defined focus such as non lesional refractory partial epilepsies.
SEEG is considered the criterion standard to localize the epileptogenic zone (EZ) but the procedure is risky with a limited spatial sampling. The development of non-invasive neuroimaging alternatives is thus an important goal to improve EZ delineation and optimize SEEG procedures.
The main hypothesis of this research project is the existence of a network organization specific for each patient which allows the generation and propagation of epileptic activities. The investigators wish to explore this network using diffusion tensor MRI to study structural connectivity and MEG/FMRI to study functional connectivity. The investigators will apply tools from the theories of complex networks and dynamical systems to characterize the network organization of epileptic process.
The investigators aimed to identify and localize differences in connectivity parameters between individual patients and a control group of healthy volunteers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epilepsy patients | – | –Epilepsy patients selected before undergoing intracranial EEG recordings |
| control group | – | –Healthy volunteers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Refractory partial epilepsy patients
Key inclusion criteria (2 listed)
- intracranial EEG recordings scheduled
- no neurological or psychiatric disease for healthy volunteers
Key exclusion criteria (2 listed)
- contraindication to MRI
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epileptic network assessed using structural and functional connectivity measures obtained with MRI and MEG
Time frame: one year
Structural connectivity will be assessed using diffusion tensor MRI including the following parameters: mean diffusivity and anisotropy at voxel level, fiber tractography. Functional connectivity will be assessed using Rs-FMRI or MEG signal correlation measures. Cortical parcellation will allow the location of connectivity parameters calculated using the graph theory. Structural and functional data from one given patient will be statistically compared those of the control group.
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 23 Jan 2025.
- Background: PubMed 20366507Chavez M, Valencia M, Navarro V, Latora V, Martinerie J. Functional modularity of background activities in normal and epileptic brain networks. Phys Rev Lett. 2010 Mar 19;104(11):118701. doi: 10.1103/PhysRevLett.104.118701. Epub 2010 Mar 18.
- OrganizationLink provided by the sponsor.
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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?
An observational study of Epilepsies, run by Institut National de la Santé Et de la Recherche Médicale, France 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 2 inclusion and 2 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 23 Jan 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?
Epileptic network assessed using structural and functional connectivity measures obtained with MRI and MEG (time frame: one year). 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 NCT01313260, 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 23 Jan 2025; AzTrials last refreshed its copy on 29 Oct 2026.