EpilepsyBRAINGRAPHNCT02305771
Contributions From the Analysis of Graphs for Identification of Neural Cliques
A study testing Electroencephalography and MRI in people with Epilepsy, run by Rennes University Hospital at 1 site in France.
Trial summary
The aim of the study is to demonstrate that our semantic knowledge (elements of our long-term memory and the process we use them) respond to a graphic organisation and gather together following accurate patterns called cliques (neural networks). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Electroencephalography and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2015to 20 Nov 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- Right-handed ;
- French native speaker
- Having given written informed consent
Who cannot join
- Presence of any psychiatric, neuropsychological and developmental disorder
- Any uncorrected visual impairment
- Any trouble or delay in learning to read / speak french
- Fully bilingual or multilingual
- Medication, treatment and / or substances that may alter or modify brain functions
- Pregnancy, breast feeding
Show all 14Show fewer
- Persons under major legal protection and/or deprived of liberty
- MRI-related criterions
- Cardiac pacemaker or implanted defibrillator
- Iron-magnetic surgical clips
- Cochlear implant
- Intra-ocular or brain foreign bodies
- Less than 4 weeks-old stents, less than 6 weeks-old osteosynthesis materials
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to demonstrate that our semantic knowledge (elements of our long-term memory and the process we use them) respond to a graphic organisation and gather together following accurate patterns called cliques (neural networks).
Read the detailed description
Electroencephalography (EEG) with very High spatial Resolution (HR) (EEG-HR, 256 electrodes) allows for a better understanding of the global and local activity of the cerebral neocortex.
In 2012, following publications by Claude Berrou and Vincent Gripon's Internet, introducing new principles of coding information based on graphical representations in connectionist networks, we approached this team to test biological plausibility of this theory in vivo with EEG.
The central concept is the mental information, defined as all elements of knowledge acquired by the long-term memory on which the reason can build to try to respond to new problems. According to this new theory, these elements of knowledge called qualia or features should be connected within cliques networks. However, we currently do not have graphs comparing methods to measure a good index of both spatial and topological similarity between graphs with high resolution electroencephalography.
For this new study, we propose to combine the strengths of several existing methods of graph comparison which, on top of this, will be especially adapted to the specific context of the analysis of the graphs in the cerebral cortex.
The skills used are diverse: information theory, mathematics, graph theory, computer science, neuropsychology, signal processing and neurology.
- Conditions
- Epilepsy
- Being tested
- Electroencephalography, MRI
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyDevice
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | 20 healthy volunteers will undergo an inclusion visit in order to check inclusion and non inclusion criteria.
Then will be performed:
* Electroencephalography
* MRI Receives: Device: Electroencephalography; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three main criteria are to be considered to validate the tool for measuring the similarity between the graphs obtained
Despite the intra-individual variability, the same object or the same sound repeated several times should generate the most similar connectivity graphs Despite the inter-individual variability, analysis of connectivity graphs must also report high similarity indices between individuals on the same stimuli or stimuli sharing the same semantic properties even if subjects are different.
At the stage of conceptual analysis of stimuli, or from 175 ms after the presentation of the image or sound, the analysis of connectivity graphs should reveal strong similarity indices for several different images of the same object (independence to the visual representation); for picture and sound representing the same object (independence to the sensory modality) or two objects belonging to the same semantic category (conceptual similarity, eg: orange, lemon). Indeed, these objects share common characteristics / semantic dimensions (eg mobile vs. stationary or living vs. non-living etc.).
Measured: 2 years
Estimate the plausibility of the results obtained with our method directly from the graphs
The density (ie: the ratio between the number of links in a given graph on the total possible number of links), the diameter (ie: the longest path in a graph), the average degree (ie: the average number of links connected to each node), the clustering (ie: the density of connections to a group of nodes with the rest of the network) and other parameters will be compared in terms of standard values available in the literature but also with tools that help to calculate the semantic distance between words such as WordNet and many others.
Measured: 2 years
Secondary outcomes (1)
Judgement of the quality of the measurement on simulated data in the laboratory test our method for measuring the similarity between the graphs
A computer model of neural network populations in which the experimenter knows in advance where the sources are allows him to test the reliability of his methods while reconstructing graphs and judging their similarity. [8] Finally, the quality of the results about the identification of neural cliques (or complete graphs) could be compared to the artificial neural network model we develop elsewhere [1, 9 and 10]. This model indicates that the distribution of neural cliques (in response to density and efficiency problems) follows a simple principle that we should find in the brain. For example, it is reasonable to think there are many cliques (or complete graphs) at the scale of a small brain region while those cliques are rare when considering spatially distant sources. It is an organization called "small-worlds" and which is classical for the neural networks in the cerebral cortex
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study start27 Feb 2015
- Primary completion20 Nov 2015
- Study completion20 Nov 2015
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 Rennes University HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305771
- Sponsor's protocol ID
- 2014-A01461-46
- Other IDs
- 35RC14_9849_BRAINGRAPH
- Acronym
- BRAINGRAPH
- Status last verified
- May 2023
- First submitted
- 28 Nov 2014
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Mheich A, Dufor O, Yassine S, Kabbara A, Biraben A, Wendling F, Hassan M. HD-EEG for tracking sub-second brain dynamics during cognitive tasks. Sci Data. 2021 Jan 27;8(1):32. doi: 10.1038/s41597-021-00821-1.
PubMed 33504796
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contributions From the Analysis of Graphs for Identification of Neural Cliques
- ClinicalTrials.gov ID
- NCT02305771
- Acronym / sponsor ID
- BRAINGRAPH / 2014-A01461-46
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 27 Feb 2015 (actual)
- Primary completion
- 20 Nov 2015 (actual)
- Study completion
- 20 Nov 2015 (actual)
- First posted
- 3 Dec 2014 (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 aim of the study is to demonstrate that our semantic knowledge (elements of our long-term memory and the process we use them) respond to a graphic organisation and gather together following accurate patterns called cliques (neural networks).
Detailed description
Electroencephalography (EEG) with very High spatial Resolution (HR) (EEG-HR, 256 electrodes) allows for a better understanding of the global and local activity of the cerebral neocortex.
In 2012, following publications by Claude Berrou and Vincent Gripon's Internet, introducing new principles of coding information based on graphical representations in connectionist networks, we approached this team to test biological plausibility of this theory in vivo with EEG.
The central concept is the mental information, defined as all elements of knowledge acquired by the long-term memory on which the reason can build to try to respond to new problems. According to this new theory, these elements of knowledge called qualia or features should be connected within cliques networks. However, we currently do not have graphs comparing methods to measure a good index of both spatial and topological similarity between graphs with high resolution electroencephalography.
For this new study, we propose to combine the strengths of several existing methods of graph comparison which, on top of this, will be especially adapted to the specific context of the analysis of the graphs in the cerebral cortex.
The skills used are diverse: information theory, mathematics, graph theory, computer science, neuropsychology, signal processing and neurology.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Device: Electroencephalography, Device: MRI20 healthy volunteers will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: * Electroencephalography * MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older
- Right-handed ;
- French native speaker
- Having given written informed consent
Key exclusion criteria (14 listed)
- Presence of any psychiatric, neuropsychological and developmental disorder
- Any uncorrected visual impairment
- Any trouble or delay in learning to read / speak french
- Fully bilingual or multilingual
- Medication, treatment and / or substances that may alter or modify brain functions
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 |
|---|---|---|
| Electroencephalography | Device | Healthy volunteers |
| MRI | Device | Healthy volunteers |
Primary outcome
Three main criteria are to be considered to validate the tool for measuring the similarity between the graphs obtained
Time frame: 2 years
Despite the intra-individual variability, the same object or the same sound repeated several times should generate the most similar connectivity graphs Despite the inter-individual variability, analysis of connectivity graphs must also report high similarity indices between individuals on the same stimuli or stimuli sharing the same semantic properties even if subjects are different. At the stage of conceptual analysis of stimuli, or from 175 ms after the presentation of the image or sound, the analysis of connectivity graphs should reveal strong similarity indices for several different images of the same object (independence to the visual representation); for picture and sound representing the same object (independence to the sensory modality) or two objects belonging to the same semantic category (conceptual similarity, eg: orange, lemon). Indeed, these objects share common characteristics / semantic dimensions (eg mobile vs. stationary or living vs. non-living etc.).
Estimate the plausibility of the results obtained with our method directly from the graphs
Time frame: 2 years
The density (ie: the ratio between the number of links in a given graph on the total possible number of links), the diameter (ie: the longest path in a graph), the average degree (ie: the average number of links connected to each node), the clustering (ie: the density of connections to a group of nodes with the rest of the network) and other parameters will be compared in terms of standard values available in the literature but also with tools that help to calculate the semantic distance between words such as WordNet and many others.
1 secondary outcome
Judgement of the quality of the measurement on simulated data in the laboratory test our method for measuring the similarity between the graphs
Time frame: 2 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 24 May 2023.
- Results publication: PubMed 33504796Mheich A, Dufor O, Yassine S, Kabbara A, Biraben A, Wendling F, Hassan M. HD-EEG for tracking sub-second brain dynamics during cognitive tasks. Sci Data. 2021 Jan 27;8(1):32. doi: 10.1038/s41597-021-00821-1.
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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 Electroencephalography and MRI in people with Epilepsy, run by Rennes University Hospital 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 4 inclusion and 14 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 24 May 2023. 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?
Three main criteria are to be considered to validate the tool for measuring the similarity between the graphs obtained (time frame: 2 years). 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 NCT02305771, 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 24 May 2023.