NCT03644732

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
53mo left

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Apr 2018Sep 2030

Study Start

First participant enrolled

April 5, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

9.9 years

First QC Date

April 9, 2018

Last Update Submit

March 18, 2024

Conditions

Keywords

Cognition

Outcome Measures

Primary Outcomes (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 (\[50-150Hz\]).

    3 weeks

Secondary Outcomes (1)

  • Behavioral data (composite measures)

    3 weeks

Study Arms (1)

SEEG Group

Group with SEEG analysis (Pre-surgical SEEG assessment)

Procedure: SEEG Group

Interventions

SEEG GroupPROCEDURE

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

SEEG Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital, Grenoble

Grenoble, 38043, France

RECRUITING

CHRU Nancy

Nancy, France

RECRUITING

Hôpital Ste Anne

Paris, 75014, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

Related Publications (6)

  • 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.

    PMID: 22750156BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Drug Resistant EpilepsyEpilepsies, Partial

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Philippe Kahane, MD/PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR
  • Marcela Perrone-Bertolotti, PhD

    Centre National de la Recherche Scientifique, France

    STUDY CHAIR

Central Study Contacts

Philippe Kahane, MD/PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2018

First Posted

August 23, 2018

Study Start

April 5, 2018

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2030

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations