Atlas of Human Cognition by SEEG (MAPCOG-SEEG) (MAPCOG-SEEG)

March 18, 2024 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SEEG Group
Group with SEEG analysis (Pre-surgical SEEG assessment)
Visual and quantitative SEEG signal analysis. As available, collection of behavioral and neuropsychological postsurgical data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]).
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).

3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Philippe Kahane, MD/PhD, University Hospital, Grenoble
  • Study Chair: Marcela Perrone-Bertolotti, PhD, Centre National de la Recherche Scientifique, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2018

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC17.357
  • 2017-A03248-45 (Other Identifier: ID RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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