Back to results

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

Primary Purpose

Epilepsy

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Implantation of mixed intracerebral electrodes

Face detection

Face individualization

About this trial

This is an interventional basic science trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service de Neurologie, Hôpital Central, CHRU de NancyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epileptic patient

Arm Description

micro-electrode recordings interventions: Implantation of mixed intracerebral electrodes Face detection Face individualization

Outcomes

Primary Outcome Measures

Number of action potential (Difference of neuronal activity) generated successively by visual presentation of 60 photography of different unknown faces and 60 different objects

Activity (number of action potential) is recorded for each neuron before and after visualization of each image.

Secondary Outcome Measures

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)

Activity (number of action potential) is recorded for each neuron before and after visualization of each image.

Full Information

NCT ID

NCT02877576

First Posted

August 19, 2016

Last Updated

April 27, 2021

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT02877576

Brief Title

Single Neurons Responses During Visual Recognition in Epileptic Patients

Acronym

REUNIE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (Actual)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Epileptic patient

Arm Type

Experimental

Arm Description

micro-electrode recordings interventions: Implantation of mixed intracerebral electrodes Face detection Face individualization

Intervention Type

Procedure

Intervention Name(s)

Implantation of mixed intracerebral electrodes

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Face detection

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Face individualization

Intervention Description

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).

Primary Outcome Measure Information:

Title

Number of action potential (Difference of neuronal activity) generated successively by visual presentation of 60 photography of different unknown faces and 60 different objects

Description

Activity (number of action potential) is recorded for each neuron before and after visualization of each image.

Time Frame

after electrode implantation, up to 12 days

Secondary Outcome Measure Information:

Title

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)

Description

Activity (number of action potential) is recorded for each neuron before and after visualization of each image.

Time Frame

after electrode implantation, up to 12 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Louis MAILLARD, Pr

l.maillard@chru-nancy.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis MAILLARD, Pr

Organizational Affiliation

Service de Neurologie CHRU de Nancy - Hôpital Central

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service de Neurologie, Hôpital Central, CHRU de Nancy

City

Nancy

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacques Jonas

First Name & Middle Initial & Last Name & Degree

Jean-Pierre Vignal

First Name & Middle Initial & Last Name & Degree

Louise Tyvaert

First Name & Middle Initial & Last Name & Degree

Sophie Colnat-Coulbois

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Single Neurons Responses During Visual Recognition in Epileptic Patients

We'll reach out to this number within 24 hrs