Clinical trial NCT02567201: Electrophysiological Evaluation of Voluntary Attention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Keywords: Voluntary attention
Electroencephalogram
Brain-computer interface
Disorders of consciousness
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Research of statistical differences between sensory evoked potentials in attentional oriented condition and distracted condition
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Online and offline accuracy
timeFrame: through study completion, an average of 3 years.
measure: Clinical scale score ("Evaluation de la Communication des patients en Eveil de Coma" (ECEC) scale)
timeFrame: an average of 3 years (At the group level)
Other outcomes:
Locations:
city: Aveize
country: France
facility: Centre Médical de L'argentière
city: Le Chambon Feugerolles
country: France
facility: Centre Hospitalier Georges Claudinon
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Lyon
country: France
facility: Centre de Recherche en Neurosciences de Lyon
city: Nantes
country: France
facility: CHU de Nantes
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: APHP - Hôpital de la Pitié Salpêtrière
city: Paris
country: France
facility: APHP - Hôpital Raymond Poincaré
city: Saint-Genis-Laval
country: France
facility: Hospices civils de Lyon, Hôpital Henry Gabrielle,
city: Saint-Maurice-sur-Dargoire
country: France
facility: Centre Médical Germaine Revel
city: Saint-Étienne
country: France
facility: Hôpital Nord CHU Saint Etienne
Study officials:
affiliation: Hospices Civils de Lyon
name: Jacques LUAUTE, MD
role: PRINCIPAL_INVESTIGATOR
References: