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AzTrials

Refractory EpilepsyMAPCOG-SEEGNCT03644732

Atlas of Human Cognition by SEEG (MAPCOG-SEEG)

An observational study of Refractory Epilepsy and Focal Epilepsy, run by University Hospital, Grenoble at 4 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main objective of MAPCOG_SEEG is to create a database including brain recordings of cognition performed in clinical routine in patients during the pre-surgical SEEG assessment. This aims to be able to propose the first atlas of human cognition with a high temporal and spatial resolution. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Refractory Epilepsy, Focal Epilepsy
What is being tested?
SEEG Group
Type of treatment
Surgery or procedure
How many people
200 participants
Where
4 sitesFrance
Study dates
5 Apr 2018to Sep 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult (Age between 18 and 65 years) patients receiving an SEEG exploration for presurgical evaluation of focal refractory epilepsy

Who may be able to join

  • Drug-resistant focal epilepsy
  • Justified SEEG exploration in the context of presurgical assessment of epilepsy
  • Written non-opposition to study participation
  • Intellectual capacities compatible with the compliance in the cognitive tasks

Who cannot join

  • Major Patient undergoing a legal protection measure or patient deprived of liberty as a result of a judicial or administrative decision
  • Impossibility of collecting information on exposure (recent arrival in France, foreign language, etc.)
  • Pregnant women (Contraindication to SEEG exploration)

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Philippe Kahane, MD/PhD contact

+33 476 765 488

pkahane@chu-grenoble.fr

Marcela Perrone-Bertolotti, PhD contact

+33 476 825 860

marcela.perrone-bertolotti@univ-grenoble-alpes.fr

France4 sites, 4 recruiting

  • University Hospital, Grenoble

    Grenoble, 38043

    Philippe Kahane, MD/PhD, +33 476 765 488, pkahane@chu-grenoble.fr

    Marcela Perrone-Bertolotti, PhD, +33 476 825 860, marcela.perrone-bertolotti@univ-grenoble-alpes.fr

    Recruiting

  • CHRU Nancy

    Nancy

    Louis MAILLARD, l.maillard@chru-nancy.fr

    Recruiting

  • Hôpital Ste Anne

    Paris, 75014

    Philippe DOMENECH, philippe.domenech@inserm.fr

    Estelle Pruvost-Robieux, e.pruvost@ghu-paris.fr

    Recruiting

  • CHU Rennes

    Rennes

    Anca NICA, Anca.NICA@chu-rennes.fr

    Recruiting

Other trials in France

About this study

Official title: Atlas of Human Cognition by SEEG

The main objective of MAPCOG_SEEG is to create a database including brain recordings of cognition performed in clinical routine in patients during the pre-surgical SEEG assessment. This aims to be able to propose the first atlas of human cognition with a high temporal and spatial resolution.

Read the detailed description

The pre-surgical assessment of a cortectomy in patient suffering from a refractory epilepsy includes several examinations aiming both, to specify the epileptogenic zone (EZ) which must be resected and to evaluate functional and cognitive risks of surgery.

Nevertheless, in some patients, non-invasive evaluation does not give formal answer. In these subjects, it is then necessary to carry out a second step, consisting of an invasive exploration by implantation of intracerebral electrodes during a Stereoelectroencephalography (SEEG).

Due to its temporal and spatial resolution, the SEEG allows, besides the precise determination of the EZ, to carry out a functional mapping of the cortical regions likely to be included in cortectomy. Conventionally, this mapping is carried out on the basis of the cortical electrical stimulations applied to the implanted electrodes. If this approach is very robust for exploring primary functions such as motor skills or language, it cannot be used to evaluate more complex cognitive tasks such as face recognition or attention. Essential cognitive tasks on a daily basis.

This has led to the development in recent years, in Grenoble, of a complementary approach to cerebral stimulation: Dynamic Spectral Imaging (ISD). Numerous experimental paradigms have demonstrated that the realization of a cognitive task associates with the generation within the cortical regions involved in its treatment of a particular cortical activity. This activity is characterized by oscillations of the cortical rhythm in high frequencies (> 40 Hz), called gamma activities. The ISD thus consists in mapping this gamma activity during various cognitive tasks, thus making it possible to study more widely the complexity of the cognitive functions.

MAPCOG_SEEG aims to collect the cerebral recording of the patients who have performed this cognitive exploration to be able to in fine propose an Atlas of human cognition which takes advantage of the very rich information in terms of spatial and temporal resolution of the SEEG. Furthermore, it will exactly allow more to understand the impact of the epilepsy and the surgery of the epilepsy on the cognition.

Being tested
SEEG Group
Keywords
Cognition
Medical subject headings
Drug Resistant Epilepsy, Epilepsies, Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SEEG GroupProcedure or surgery

    Visual and quantitative SEEG signal analysis. As available, collection of behavioral and neuropsychological postsurgical data

Study groups in NCT03644732
Study groupRoleWhat they receive
SEEG GroupGroup with SEEG analysis (Pre-surgical SEEG assessment)
Receives: Procedure: SEEG Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SEEG recordings using functional brain mapping procedure (composite measures)

    Prospective collection of data from SEEG recordings using functional brain mapping procedure performed in clinical routine during the presurgical assessment of patients with drug-resistant epilepsy. These data are represented by the electroencephalographic activity during the realization of the different cognitive tasks proposed to the patients. Electroencephalographic activity will then be analyzed in terms of Dynamic Spectral Imaging and in terms of high frequency activity ([50-150Hz]).

    Measured: 3 weeks

Secondary outcomes (1)

  1. Behavioral data (composite measures)

    Behavioral data (reaction time and accuracy of response) collected during the presurgical assessment (joint with the SEEG) and during the postsurgical follow-up (approximately 3 months after the surgery) as well as the collection of neuropsychological scores from the presurgical and postsurgical assessment.

    Behavioral performance and neuropsychological test scores before and after surgery (as available) will allow to evaluate the impact of surgery on cognitive functioning (improvement or deterioration of cognitive performance).

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2018
  2. Study start5 Apr 2018
  3. Primary completionMar 2028 (estimated)
  4. Study completionSep 2030 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03644732
Sponsor's protocol ID
38RC17.357
Other IDs
2017-A03248-45
Acronym
MAPCOG-SEEG
Status last verified
Mar 2024
First submitted
9 Apr 2018
Last updated
19 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lachaux JP, Axmacher N, Mormann F, Halgren E, Crone NE. High-frequency neural activity and human cognition: past, present and possible future of intracranial EEG research. Prog Neurobiol. 2012 Sep;98(3):279-301. doi: 10.1016/j.pneurobio.2012.06.008. Epub 2012 Jun 26.

    PubMed 22750156

  • Baciu M, Perrone-Bertolotti M. What do patients with epilepsy tell us about language dynamics? A review of fMRI studies. Rev Neurosci. 2015;26(3):323-41. doi: 10.1515/revneuro-2014-0074.

    PubMed 25741734

  • Combrisson E, Perrone-Bertolotti M, Soto JL, Alamian G, Kahane P, Lachaux JP, Guillot A, Jerbi K. From intentions to actions: Neural oscillations encode motor processes through phase, amplitude and phase-amplitude coupling. Neuroimage. 2017 Feb 15;147:473-487. doi: 10.1016/j.neuroimage.2016.11.042. Epub 2016 Nov 30.

    PubMed 27915117

  • Ossandon T, Vidal JR, Ciumas C, Jerbi K, Hamame CM, Dalal SS, Bertrand O, Minotti L, Kahane P, Lachaux JP. Efficient "pop-out" visual search elicits sustained broadband gamma activity in the dorsal attention network. J Neurosci. 2012 Mar 7;32(10):3414-21. doi: 10.1523/JNEUROSCI.6048-11.2012.

    PubMed 22399764

  • Perrone-Bertolotti M, Vidal JR, de Palma L, Hamame CM, Ossandon T, Kahane P, Minotti L, Bertrand O, Lachaux JP. Turning visual shapes into sounds: early stages of reading acquisition revealed in the ventral occipitotemporal cortex. Neuroimage. 2014 Apr 15;90:298-307. doi: 10.1016/j.neuroimage.2013.12.027. Epub 2013 Dec 24.

    PubMed 24370818

  • Perrone-Bertolotti M, Kujala J, Vidal JR, Hamame CM, Ossandon T, Bertrand O, Minotti L, Kahane P, Jerbi K, Lachaux JP. How silent is silent reading? Intracerebral evidence for top-down activation of temporal voice areas during reading. J Neurosci. 2012 Dec 5;32(49):17554-62. doi: 10.1523/JNEUROSCI.2982-12.2012.

    PubMed 23223279

Questions about this trial

What is this clinical trial studying?

An observational study of Refractory Epilepsy and Focal Epilepsy, run by University Hospital, Grenoble at 4 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 3 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: looking for participants now, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philippe Kahane, MD/PhD (+33 476 765 488, pkahane@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SEEG recordings using functional brain mapping procedure (composite measures) (time frame: 3 weeks). 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 NCT03644732, which also lists 6 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 19 Mar 2024.

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