Atlas of Human Cognition by SEEG (MAPCOG-SEEG) (MAPCOG-SEEG)
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| ClinicalTrials.gov Identifier: NCT03644732 |
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Recruitment Status :
Recruiting
First Posted : August 23, 2018
Last Update Posted : December 4, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Refractory Epilepsy Focal Epilepsy | Procedure: SEEG Group |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Atlas of Human Cognition by SEEG |
| Actual Study Start Date : | April 5, 2018 |
| Estimated Primary Completion Date : | March 2028 |
| Estimated Study Completion Date : | September 2030 |
| Group/Cohort | Intervention/treatment |
|---|---|
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SEEG Group
Group with SEEG analysis (Pre-surgical SEEG assessment)
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Procedure: SEEG Group
Visual and quantitative SEEG signal analysis. As available, collection of behavioral and neuropsychological postsurgical data |
- SEEG recordings using functional brain mapping procedure (composite measures) [ Time Frame: 3 weeks ]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]).
- Behavioral data (composite measures) [ Time Frame: 3 weeks ]
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).
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644732
| Contact: Philippe Kahane, MD/PhD | +33 476 765 488 | pkahane@chu-grenoble.fr | |
| Contact: Marcela Perrone-Bertolotti, PhD | +33 476 825 860 | marcela.perrone-bertolotti@univ-grenoble-alpes.fr |
| France | |
| University Hospital, Grenoble | Recruiting |
| Grenoble, France, 38043 | |
| Contact: Philippe Kahane, MD/PhD +33 476 765 488 pkahane@chu-grenoble.fr | |
| Contact: Marcela Perrone-Bertolotti, PhD +33 476 825 860 marcela.perrone-bertolotti@univ-grenoble-alpes.fr | |
| CHRU Nancy | Recruiting |
| Nancy, France | |
| Contact: Louis MAILLARD l.maillard@chru-nancy.fr | |
| CHU Rennes | Recruiting |
| Rennes, France | |
| Contact: Anca NICA Anca.NICA@chu-rennes.fr | |
| Principal Investigator: | Philippe Kahane, MD/PhD | University Hospital, Grenoble | |
| Study Chair: | Marcela Perrone-Bertolotti, PhD | Centre National de la Recherche Scientifique, France |
Other Publications:
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT03644732 |
| Other Study ID Numbers: |
38RC17.357 2017-A03248-45 ( Other Identifier: ID RCB ) |
| First Posted: | August 23, 2018 Key Record Dates |
| Last Update Posted: | December 4, 2020 |
| Last Verified: | December 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cognition |
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Epilepsy Drug Resistant Epilepsy Epilepsies, Partial |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |