NCT02877576

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 28, 2021

Status Verified

July 1, 2020

Enrollment Period

7 years

First QC Date

August 19, 2016

Last Update Submit

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

EXPERIMENTAL

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

Procedure: Implantation of mixed intracerebral electrodesBehavioral: Face detectionBehavioral: 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).

Epileptic patient
Face detectionBEHAVIORAL

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.

Epileptic patient

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).

Epileptic patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

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.

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Louis MAILLARD, Pr

    Service de Neurologie CHRU de Nancy - Hôpital Central

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis MAILLARD, Pr

CONTACT

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

Locations