Electrophysiological Evaluation of Voluntary Attention

NCT ID: NCT02567201

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-16
• Study Completion Date: 2024-10-15

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Electrophysiological assessment of Healthy subjects

Experiences 1, 2 and 3 with healthy subjects

Group Type: EXPERIMENTAL

electrophysiological evaluation

Intervention Type: 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 patients

Experiences 1, 2 and 3 with patients

Group Type: EXPERIMENTAL

electrophysiological evaluation of patients

Intervention Type: 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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques LUAUTE, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Centre Médical de L'argentière

Aveize, , France

Centre Hospitalier Georges Claudinon

Le Chambon-Feugerolles, , France

Hospices Civils de Lyon

Lyon, , France

Centre de Recherche en Neurosciences 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-Etienne, , France

Hospices civils de Lyon, Hôpital Henry Gabrielle,

Saint-Genis-Laval, , France

Centre Médical Germaine Revel

Saint-Maurice-sur-Dargoire, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 38238759 (View on PubMed)

Other Identifiers

2015-A00635-44

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL15_0216

Identifier Type: -

Identifier Source: org_study_id