Electrophysiological Evaluation of Voluntary Attention

Not Applicable

Completed

• Conditions: Brain Injury
• Interventions: Other: electrophysiological evaluation; Other: electrophysiological evaluation of patients

• Registration Number: NCT02567201
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-02
• Study Start: 2015-10-16
• Status Verified: 2024-02
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrophysiological assessment of Healthy subjects	electrophysiological evaluation	Experiences 1, 2 and 3 with healthy subjects
Electrophysiological assessment of patients	electrophysiological evaluation of patients	Experiences 1, 2 and 3 with patients

Primary Outcome Measures

Name	Time	Method
Research of statistical differences between sensory evoked potentials in attentional oriented condition and distracted condition	through study completion, an average of 3 years	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

Name	Time	Method
Online and offline accuracy	through study completion, an average of 3 years.	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)	an average of 3 years (At the group level)	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.

Trial Locations

Locations (11)

Centre Médical de L'argentière; 🇫🇷 Aveize, France

Centre Hospitalier Georges Claudinon; 🇫🇷 Le Chambon Feugerolles, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Centre de Recherche en Neurosciences de Lyon; 🇫🇷 Lyon, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Nîmes; 🇫🇷 Nîmes, France

APHP - Hôpital de la Pitié Salpêtrière; 🇫🇷 Paris, France

APHP - Hôpital Raymond Poincaré; 🇫🇷 Paris, France

Hospices civils de Lyon, Hôpital Henry Gabrielle,; 🇫🇷 Saint-Genis-Laval, France

Centre Médical Germaine Revel; 🇫🇷 Saint-Maurice-sur-Dargoire, France

Hôpital Nord CHU Saint Etienne; 🇫🇷 Saint-Étienne, France