Electrophysiological Evaluation of Voluntary Attention (EVA)

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.

Study Overview

• Status: Completed
• Conditions: Brain Injury
• Intervention / Treatment: Other: electrophysiological evaluation; Other: electrophysiological evaluation of patients

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aveize, France, 69610
    • Centre Médical de L'argentière
  • Le Chambon Feugerolles, France, 42500
    • Centre Hospitalier Georges Claudinon
  • Lyon, France, 69002
    • Hospices civils de Lyon
  • Lyon, France, 69500
    • Centre de Recherche en Neurosciences de Lyon
  • Nantes, France, 44000
    • CHU de Nantes
  • Nîmes, France, 30900
    • CHU de Nîmes
  • Paris, France, 75004
    • APHP - Hôpital de la Pitié Salpétrière
  • Paris, France, 92380
    • APHP - Hôpital Raymond Poincaré
  • Saint-Genis-Laval, France, 69230
    • Hospices civils de Lyon, Hôpital Henry Gabrielle,
  • Saint-Maurice-sur-Dargoire, France, 69440
    • Centre Médical Germaine REVEL
  • Saint-Étienne, France, 42000
    • Hopital Nord Chu Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrophysiological assessment of Healthy subjects; Experiences 1, 2 and 3 with healthy subjects	Other: electrophysiological evaluation; electrophysiological assessment (experience 1 : passive ; experience 2 : active versus passive ; experience 3 : active, with feedback) Experience 1, 2, 3 : one session maximum by experience
Experimental: Electrophysiological assessment of patients; Experiences 1, 2 and 3 with patients	Other: electrophysiological evaluation of patients; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.).	through study completion, an average of 3 years.
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.	an average of 3 years (At the group level)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jacques LUAUTE, MD, Hospices civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2015
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimated): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Electroencephalogram; Disorders of consciousness; Brain-computer interface; Voluntary attention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: 69HCL15_0216; 2015-A00635-44 (Other Identifier: ID-RCB)