Brain InjuryEVANCT02567201
Electrophysiological Evaluation of Voluntary Attention
A study testing electrophysiological evaluation and electrophysiological evaluation of patients in people with Brain Injury, run by Hospices Civils de Lyon at 11 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injury
- What is being tested?
- electrophysiological evaluation and electrophysiological evaluation of patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 11 sitesFrance
- Study dates
- 16 Oct 2015to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Centre Médical de L'argentière
Aveize, 69610
Centre Hospitalier Georges Claudinon
Le Chambon-Feugerolles, 42500
Hospices Civils de Lyon
Lyon, 69002
Centre de Recherche en Neurosciences de Lyon
Lyon, 69500
CHU de Nantes
Nantes, 44000
CHU de Nîmes
Nîmes, 30900
APHP - Hôpital de la Pitié Salpêtrière
Paris, 75004
APHP - Hôpital Raymond Poincaré
Paris, 92380
Hôpital Nord CHU Saint Etienne
Saint-Etienne, 42000
Hospices civils de Lyon, Hôpital Henry Gabrielle,
Saint-Genis-Laval, 69230
Centre Médical Germaine Revel
Saint-Maurice-sur-Dargoire, 69440
About this study
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
- Being tested
- electrophysiological evaluation, electrophysiological evaluation of patients
- Keywords
- Voluntary attention, Electroencephalogram, Brain-computer interface, Disorders of consciousness
- Medical subject headings
- Brain Injuries, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrophysiological evaluationOther
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 patientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrophysiological assessment of Healthy subjects | Experimental | Experiences 1, 2 and 3 with healthy subjects Receives: Other: electrophysiological evaluation |
| Electrophysiological assessment of patients | Experimental | Experiences 1, 2 and 3 with patients Receives: Other: electrophysiological evaluation of patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 3 years
Secondary outcomes (2)
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.).
Measured: 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.
Measured: an average of 3 years (At the group level)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start16 Oct 2015
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques LUAUTE, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567201
- Sponsor's protocol ID
- 69HCL15_0216
- Other IDs
- 2015-A00635-44
- Acronym
- EVA
- Status last verified
- Feb 2024
- First submitted
- 28 Sep 2015
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38238759
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Evaluation of Voluntary Attention
- ClinicalTrials.gov ID
- NCT02567201
- Acronym / sponsor ID
- EVA / 69HCL15_0216
- Conditions
- Brain Injury
- Keywords
- Voluntary attention, Electroencephalogram, Brain-computer interface, Disorders of consciousness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Oct 2015 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrophysiological assessment of Healthy subjects | Experimental | Other: electrophysiological evaluationExperiences 1, 2 and 3 with healthy subjects |
| Electrophysiological assessment of patients | Experimental | Other: electrophysiological evaluation of patientsExperiences 1, 2 and 3 with patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrophysiological evaluationelectrophysiological assessment (experience 1 : passive ; experience 2 : active versus passive ; experience 3 : active, with feedback) Experience 1, 2, 3 : one session maximum by experience | Other | Electrophysiological assessment of Healthy subjects |
| electrophysiological evaluation of patientselectrophysiological 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. | Other | Electrophysiological assessment of patients |
Primary outcome
Research of statistical differences between sensory evoked potentials in attentional oriented condition and distracted condition
Time frame: through study completion, an average of 3 years
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
2 secondary outcomes
Online and offline accuracy
Time frame: through study completion, an average of 3 years.
Clinical scale score ("Evaluation de la Communication des patients en Eveil de Coma" (ECEC) scale)
Time frame: an average of 3 years (At the group level)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Derived from this study: PubMed 38238759Seguin 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques LUAUTE, MD principal investigator
Hospices Civils de Lyon
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrophysiological evaluation and electrophysiological evaluation of patients in people with Brain Injury, run by Hospices Civils de Lyon at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Research of statistical differences between sensory evoked potentials in attentional oriented condition and distracted condition (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02567201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.