Single Neurons Responses During Visual Recognition in Epileptic Patients
REUNIE
Study of Cerebral Mechanisms of Visual Recognition With Single-unit Recordings of Intra-cerebral Neurons in Epileptic Patients
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 19, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedApril 28, 2021
July 1, 2020
7 years
August 19, 2016
April 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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)
after electrode implantation, up to 12 days
Study Arms (1)
Epileptic patient
EXPERIMENTALmicro-electrode recordings interventions: Implantation of mixed intracerebral electrodes Face detection Face individualization
Interventions
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).
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.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Neurologie, Hôpital Central, CHRU de Nancy
Nancy, France
Related Publications (1)
Le Cam S, Jurczynski P, Jonas J, Koessler L, Colnat-Coulbois S, Ranta R. A Bayesian approach for simultaneous spike/LFP separation and spike sorting. J Neural Eng. 2023 Mar 31;20(2). doi: 10.1088/1741-2552/acc210.
PMID: 36881899DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louis MAILLARD, Pr
Service de Neurologie CHRU de Nancy - Hôpital Central
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2016
First Posted
August 24, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
April 28, 2021
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share