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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00635-44 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrophysiological assessment of Healthy subjects | Experimental | Experiences 1, 2 and 3 with healthy subjects |
|
| Electrophysiological assessment of patients | Experimental | Experiences 1, 2 and 3 with patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electrophysiological evaluation | Other | electrophysiological assessment (experience 1 : passive ; experience 2 : active versus passive ; experience 3 : active, with feedback) Experience 1, 2, 3 : one session maximum by experience |
| 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 |
| 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.). |
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Inclusion Criteria:
Inclusion criteria for patients :
Adults, man or woman, left or right-handed, from 18 years old to 80 years-old ;
Diagnosis :
< 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
Inclusion criteria of Healthy subjects
Exclusion criteria of patients and healthy subjects
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| Name | Affiliation | Role |
|---|---|---|
| Jacques LUAUTE, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Médical de L'argentière | Aveize | 69610 | France | |||
| Centre Hospitalier Georges Claudinon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38238759 | Derived | Seguin P, Maby E, Fouillen M, Otman A, Luaute J, Giraux P, Morlet D, Mattout J. The challenge of controlling an auditory BCI in the case of severe motor disability. J Neuroeng Rehabil. 2024 Jan 18;21(1):9. doi: 10.1186/s12984-023-01289-3. |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| electrophysiological evaluation of patients | Other | 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. |
|
| 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) |
| Le Chambon-Feugerolles |
| 42500 |
| France |
| Hospices Civils de Lyon | Lyon | 69002 | France |
| Centre de Recherche en Neurosciences de Lyon | Lyon | 69500 | France |
| CHU de Nantes | Nantes | 44000 | France |
| CHU de Nîmes | Nîmes | 30900 | France |
| APHP - Hôpital de la Pitié Salpêtrière | Paris | 75004 | France |
| APHP - Hôpital Raymond Poincaré | Paris | 92380 | France |
| Hôpital Nord CHU Saint Etienne | Saint-Etienne | 42000 | France |
| Hospices civils de Lyon, Hôpital Henry Gabrielle, | Saint-Genis-Laval | 69230 | France |
| Centre Médical Germaine Revel | Saint-Maurice-sur-Dargoire | 69440 | France |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |