Electrophysiological Evaluation of Voluntary Attention (EVA)

Civil Hospices of Lyon

Status: Completed

Conditions: Brain Injury

Treatments: Other: electrophysiological evaluation of patients; Other: electrophysiological evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT02567201

2015-A00635-44 (Other Identifier)

69HCL15_0216

Details and patient eligibility

About

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.

Enrollment: 214 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Electrophysiological assessment of Healthy subjects

Experimental group

Description:

Experiences 1, 2 and 3 with healthy subjects

Treatment:

Other: electrophysiological evaluation

Electrophysiological assessment of patients

Experimental group

Description:

Experiences 1, 2 and 3 with patients

Treatment:

Other: electrophysiological evaluation of patients