Single Neurons Responses During Visual Recognition in Epileptic Patients (REUNIE)

April 27, 2021 updated by: Central Hospital, Nancy, France

Study of Cerebral Mechanisms of Visual Recognition With Single-unit Recordings of Intra-cerebral Neurons in Epileptic Patients

The purpose is to evaluate specific capacities of face detection of individual neurons by comparison with their capacity of object detection in medial temporal lobe and ventral temporal cortex in epileptic patients.

Secondary purpose is to evaluate specific capacities of detection of known faces of individual neurons by comparison with their capacity of detection of unknown faces in medial temporal lobe and ventral temporal cortex in epileptic patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this interventional study, patients explored with mixed intracerebral electrodes (micro and macro-contacts) will be presented sets of images (objects, unknown faces, famous faces). Spikes and Multi-Unit-Activity will be recorded and analyzed and compared between conditions.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

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 Locations

  • France
      • Nancy, France
        • Recruiting
        • Service de Neurologie, Hôpital Central, CHRU de Nancy
        • Sub-Investigator:
          • Jacques Jonas
        • Sub-Investigator:
          • Jean-Pierre Vignal
        • Sub-Investigator:
          • Louise Tyvaert

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with temporal or occipito-temporal drug-resistant partial epilepsy, symptomatic, needing surgical treatment
  • Patient having signed informed consent
  • Patient affiliated to social security
  • Patient having undergone preliminary medical examination

Exclusion Criteria:

  • Persons under legal protection or incapable to consent
  • Persons deprived of liberty by juridical or administrative decision
  • Patient with severe visual disorders of neurological or ophthalmological origin
  • Patients with infection risk according to doctor or surgeon
  • Women without effective contraception
  • Pregnant or breast-feeding women

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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Epileptic patient
micro-electrode recordings interventions: Implantation of mixed intracerebral electrodes Face detection Face individualization
Procedure: Implantation of mixed intracerebral electrodes

5 macro electrodes with micro electrodes are implanted in internal temporal structures (amygdala, anterior and posterior hippocampus, rhinal cortex, posterior para-hippocampal gyrus).

Each electrode has 8 microcontacts, each recording the activity of 0 to 3 neurons (activity of 0 to 120 neurons/patient).

Behavioral: Face detection
Visualization of images of 60 unknown faces and 60 objects that are not faces (object, house, scene, animal, plant, word, letter…). Each image is showed for 500 ms and separated from following image by black screen of 1500 ms. In order to keep patient attention on image, patient will be asked to push a button at color change of fixation cross in the centre of image.
Behavioral: Face individualization

Visualization of images of celebrities (persons known by patient), showed randomly. Each image is showed for 500 ms and separated from following image by black screen of 1500 ms. In order to keep patient attention on image, patient will be asked to push a button at color change of fixation cross in the centre of image.

Several celebrities are showed, with for each the presentation of 60 images different from that celebrity. 1 to 3 celebrities are showed (60 to 180 total images).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of action potential (Difference of neuronal activity) generated successively by visual presentation of 60 photography of different unknown faces and 60 different objects
Time Frame: after electrode implantation, up to 12 days
Activity (number of action potential) is recorded for each neuron before and after visualization of each image.
after electrode implantation, up to 12 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of action potential (Difference of neuronal activity) generated by visual presentation of 60 photography of a known target face (familiar) and 60 photography of unknown faces (non familiar)
Time Frame: after electrode implantation, up to 12 days
Activity (number of action potential) is recorded for each neuron before and after visualization of each image.
after electrode implantation, up to 12 days

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Louis MAILLARD, Pr, Service de Neurologie CHRU de Nancy - Hôpital Central

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)

May 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

May 1, 2023

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (ESTIMATE)

August 24, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A01951-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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