Single Neurons Responses During Visual Recognition in Epileptic Patients

Epilepsy Clinical Trial

— REUNIE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02877576
• Other study ID #: 2015-A01951-48
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2023

Study information

• Verified date: July 2020
• Source: Central Hospital, Nancy, France
• Contact: Louis MAILLARD, Pr
• Email: l.maillard[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.
• 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).

Locations

Country	Name	City	State
France	Service de Neurologie, Hôpital Central, CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	after electrode implantation, up to 12 days
Secondary	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.	after electrode implantation, up to 12 days