Electrophysiological Evaluation of Voluntary Attention

NCT02567201 | Completed

• 2 other identifiers: 69HCL15_02162015-A00635-44
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 11

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.

Conditions

Brain Injury

Keywords

Voluntary attention; Electroencephalogram; Brain-computer interface; Disorders of consciousness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Online and offline accuracy

  through study completion, an average of 3 years.

• Clinical scale score ("Evaluation de la Communication des patients en Eveil de Coma" (ECEC) scale)

  an average of 3 years (At the group level)

Study Arms (2)

Electrophysiological assessment of Healthy subjects

EXPERIMENTAL

Experiences 1, 2 and 3 with healthy subjects

Other: electrophysiological evaluation

Electrophysiological assessment of patients

EXPERIMENTAL

Experiences 1, 2 and 3 with patients

Other: electrophysiological evaluation of patients

Interventions

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

Electrophysiological assessment of Healthy subjects

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.

Electrophysiological assessment of patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (11)

Centre Médical de L'argentière

Aveize, 69610, France

Location

Centre Hospitalier Georges Claudinon

Le Chambon-Feugerolles, 42500, France

Location

Hospices Civils de Lyon

Lyon, 69002, France

Location

Centre de Recherche en Neurosciences de Lyon

Lyon, 69500, France

Location

CHU de Nantes

Nantes, 44000, France

Location

CHU de Nîmes

Nîmes, 30900, France

Location

APHP - Hôpital de la Pitié Salpêtrière

Paris, 75004, France

Location

APHP - Hôpital Raymond Poincaré

Paris, 92380, France

Location

Hôpital Nord CHU Saint Etienne

Saint-Etienne, 42000, France

Location

Hospices civils de Lyon, Hôpital Henry Gabrielle,

Saint-Genis-Laval, 69230, France

Location

Centre Médical Germaine Revel

Saint-Maurice-sur-Dargoire, 69440, France

Location

Related Publications (1)

• 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.

  PMID: 38238759 DERIVED

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jacques LUAUTE, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 2, 2015
• Study Start: October 16, 2015
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-02

Locations

FR (11)