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Electrophysiological Evaluation of Voluntary Attention (EVA)

Primary Purpose

Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electrophysiological evaluation
electrophysiological evaluation of patients
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Injury focused on measuring Voluntary attention, Electroencephalogram, Brain-computer interface, Disorders of consciousness

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion criteria for patients :

  • Adults, man or woman, left or right-handed, from 18 years old to 80 years-old ;
  • Diagnosis :

    • Locked-in syndrome :

< Brainstem injury, without any evolution for at least 3 week, etiology : vascular, traumatic < Amyotrophic Lateral Sclerosis < Following damage to the central or peripheral nervous system

  • Or Minimal conscious state or Unresponsive Wakefulness Syndrome consecutive to a severe acquired brain injury for at least one month
  • Or with a severe brain injury, since birth or acquired, for at least one month
  • Or with Guillain-Barré syndrome

    • Subjects affiliated to social security;
    • Signature of consent form by the patient or by a relative (family member or "the trusted person") if obtaining a consent is impossible

Inclusion criteria of Healthy subjects

  • Adults, man or woman, left or right-handed, from 18 years old to 80 years-old ;
  • Without known auditory impairment
  • Subjects able to understand the experimental instructions
  • Subjects affiliated to social security;
  • Signature of consent form

Exclusion criteria of patients and healthy subjects

  • Medical history : psychiatric disorders (except if due to brain injury), neurologic disorders (except if due to brain injury)
  • For healthy subjects : history of brain injury
  • Pregnant women or breastfeeding women
  • Person under legal protection
  • Medico-legal conflicts
  • Absence of consent by the subject or the patient or his/her representant

Sites / Locations

  • Centre Médical de L'argentièreRecruiting
  • Centre Hospitalier Georges ClaudinonRecruiting
  • Hospices Civils de LyonRecruiting
  • Centre de Recherche en Neurosciences de LyonRecruiting
  • CHU de Nantes
  • CHU de Nîmes
  • APHP - Hôpital de la Pitié SalpêtrièreRecruiting
  • APHP - Hôpital Raymond PoincaréRecruiting
  • Hospices civils de Lyon, Hôpital Henry Gabrielle,Recruiting
  • Centre Médical Germaine RevelRecruiting
  • Hôpital Nord CHU Saint EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Electrophysiological assessment of Healthy subjects

Electrophysiological assessment of patients

Arm Description

Experiences 1, 2 and 3 with healthy subjects

Experiences 1, 2 and 3 with patients

Outcomes

Primary Outcome Measures

Research of statistical differences between sensory evoked potentials in attentional oriented condition and distracted condition
stastical analysis allowing to compare evoked responses during different stimulation condition (attentionnaly oriented versus attentionnally distracted versus passive condition = no instruction to the subject). These comparisons are made either for one single subject and at the group level. Analysis mainly concerns the differences in amplitude variation between the differents evoked potentials on several electrods of interest. These can vary between patients because of the different topographies of lesions and because of the different adaptative strategies. The statiscal difference will be assessed by a randomization test (also called "permutation test") wich allow to assess how high is the risk that the observed difference between the evoked potential (amplitude, variance) is due to chance or not

Secondary Outcome Measures

Online and offline accuracy
percentage of correct answers with the brain-computer interface (BCI). A "correct answer" is recorded each time the feedback of the BCI match the command sended by the subject controlling the BCI. This analysis can be done online and offline. Online accuracy is recorded in real-time during the session with the subject. offline accuracy is obtained a posteriori of the experiment, to test the impact on accuracy of the changes in different parameters (stimuli duration, numbers of spatial filtering, change of classifiers, etc.).
Clinical scale score ("Evaluation de la Communication des patients en Eveil de Coma" (ECEC) scale)
this clinical scale allow to obtain an outcome measure of the investissment, the communication themes and the communication modes of the patient. The final global value range between 0 and 44.

Full Information

First Posted
September 28, 2015
Last Updated
October 18, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02567201
Brief Title
Electrophysiological Evaluation of Voluntary Attention
Acronym
EVA
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2015 (Actual)
Primary Completion Date
October 15, 2025 (Anticipated)
Study Completion Date
October 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim : To assess the ability of healthy subjects and patients with a severe motor disability to voluntary control their attention Material and Methods: Population: healthy subjects, patients with brain injury Electroencephalographic study to research attentional modulation during different kind of stimulation (visual, auditory, tactile) Sudy 1: passive recording. Study 2: active recording (instruction of attentional control given to the subject). Study 3: active recording with a feedback obtained after a processing of the brain activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury
Keywords
Voluntary attention, Electroencephalogram, Brain-computer interface, Disorders of consciousness

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electrophysiological assessment of Healthy subjects
Arm Type
Experimental
Arm Description
Experiences 1, 2 and 3 with healthy subjects
Arm Title
Electrophysiological assessment of patients
Arm Type
Experimental
Arm Description
Experiences 1, 2 and 3 with patients
Intervention Type
Other
Intervention Name(s)
electrophysiological evaluation
Intervention Description
electrophysiological assessment (experience 1 : passive ; experience 2 : active versus passive ; experience 3 : active, with feedback) Experience 1, 2, 3 : one session maximum by experience
Intervention Type
Other
Intervention Name(s)
electrophysiological evaluation of patients
Intervention Description
electrophysiological assessment (experience 1 : passive ; experience 2 : active versus passive ; experience 3 : active, with feedback) Experience 1 : maximum one session by sensory modality of stimulation (auditory, tactile, or visual) Experience 2 : maximum one session by sensory modality of stimulation (auditory, tactile, or visual) Experience 3 : Stimulation = auditory or visual ; possibility of several sessions if the patient is tired.
Primary Outcome Measure Information:
Title
Research of statistical differences between sensory evoked potentials in attentional oriented condition and distracted condition
Description
stastical analysis allowing to compare evoked responses during different stimulation condition (attentionnaly oriented versus attentionnally distracted versus passive condition = no instruction to the subject). These comparisons are made either for one single subject and at the group level. Analysis mainly concerns the differences in amplitude variation between the differents evoked potentials on several electrods of interest. These can vary between patients because of the different topographies of lesions and because of the different adaptative strategies. The statiscal difference will be assessed by a randomization test (also called "permutation test") wich allow to assess how high is the risk that the observed difference between the evoked potential (amplitude, variance) is due to chance or not
Time Frame
through study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
Online and offline accuracy
Description
percentage of correct answers with the brain-computer interface (BCI). A "correct answer" is recorded each time the feedback of the BCI match the command sended by the subject controlling the BCI. This analysis can be done online and offline. Online accuracy is recorded in real-time during the session with the subject. offline accuracy is obtained a posteriori of the experiment, to test the impact on accuracy of the changes in different parameters (stimuli duration, numbers of spatial filtering, change of classifiers, etc.).
Time Frame
through study completion, an average of 3 years.
Title
Clinical scale score ("Evaluation de la Communication des patients en Eveil de Coma" (ECEC) scale)
Description
this clinical scale allow to obtain an outcome measure of the investissment, the communication themes and the communication modes of the patient. The final global value range between 0 and 44.
Time Frame
an average of 3 years (At the group level)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for patients : Adults, man or woman, left or right-handed, from 18 years old to 80 years-old ; Diagnosis : Locked-in syndrome : < Brainstem injury, without any evolution for at least 3 week, etiology : vascular, traumatic < Amyotrophic Lateral Sclerosis < Following damage to the central or peripheral nervous system Or Minimal conscious state or Unresponsive Wakefulness Syndrome consecutive to a severe acquired brain injury for at least one month Or with a severe brain injury, since birth or acquired, for at least one month Or with Guillain-Barré syndrome Subjects affiliated to social security; Signature of consent form by the patient or by a relative (family member or "the trusted person") if obtaining a consent is impossible Inclusion criteria of Healthy subjects Adults, man or woman, left or right-handed, from 18 years old to 80 years-old ; Without known auditory impairment Subjects able to understand the experimental instructions Subjects affiliated to social security; Signature of consent form Exclusion criteria of patients and healthy subjects Medical history : psychiatric disorders (except if due to brain injury), neurologic disorders (except if due to brain injury) For healthy subjects : history of brain injury Pregnant women or breastfeeding women Person under legal protection Medico-legal conflicts Absence of consent by the subject or the patient or his/her representant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacques LUAUTE, MD
Phone
4. 27. 85. 62. 96
Ext
+33
Email
jacques.luaute@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jérémie Mattout, PhD
Phone
4 72 13 89 00
Ext
+33
Email
jeremie.mattout@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques LUAUTE, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Médical de L'argentière
City
Aveize
ZIP/Postal Code
69610
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Sarraf, Dr
Facility Name
Centre Hospitalier Georges Claudinon
City
Le Chambon Feugerolles
ZIP/Postal Code
42500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Julie Françon, Dr
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques LUAUTE, MD
Phone
4. 27. 85. 62. 96
Ext
+33
Email
jacques.luaute@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Jérémie Mattout, PhD
Phone
4 72 13 89 00
Ext
+33
Email
jeremie.mattout@inserm.fr
Facility Name
Centre de Recherche en Neurosciences de Lyon
City
Lyon
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Luaute, Pr
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphaël GROSS, Dr
Email
Raphael.gross@chu-nantes.fr
Facility Name
CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30900
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic PELLAS, DR
Ext
+33
Email
Frederic.pellas@chu-nimes.fr
Facility Name
APHP - Hôpital de la Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Rohaut, Dr
Facility Name
APHP - Hôpital Raymond Poincaré
City
Paris
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaud Lansaman, Dr
Facility Name
Hospices civils de Lyon, Hôpital Henry Gabrielle,
City
Saint-Genis-Laval
ZIP/Postal Code
69230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Luaute, Pr
Facility Name
Centre Médical Germaine Revel
City
Saint-Maurice-sur-Dargoire
ZIP/Postal Code
69440
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivien Reynaud, Dr
Facility Name
Hôpital Nord CHU Saint Etienne
City
Saint-Étienne
ZIP/Postal Code
42000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Camdessanche, Dr

12. IPD Sharing Statement

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Electrophysiological Evaluation of Voluntary Attention

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