Electrophysiological Evaluation of Voluntary Attention

Brain Injury Clinical Trial

— EVA  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02567201
• Other study ID #: 69HCL15_0216
• Secondary ID: 2015-A00635-44
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2015
• Est. completion date: October 15, 2025

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: Jacques LUAUTE, MD
• Phone: 4. 27. 85. 62. 96
• Email: jacques.luaute[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury

Intervention

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
• 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.

Locations

Country	Name	City	State
France	Centre Médical de L'argentière	Aveize
France	Centre Hospitalier Georges Claudinon	Le Chambon Feugerolles
France	Centre de Recherche en Neurosciences de Lyon	Lyon
France	Hospices Civils 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	Hôpital Nord CHU Saint Etienne	Saint-Étienne
France	Hospices civils de Lyon, Hôpital Henry Gabrielle,	Saint-Genis-Laval
France	Centre Médical Germaine Revel	Saint-Maurice-sur-Dargoire

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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)