Disorder of ConsciousnessNeurodocNCT04035655
Sub-study of the NEURODOC Project : Neurophysiological Evaluation of a Routine Care Open Label tDCS Session
A study testing Coma Recovery Scale - revised and Electrophysiological recordings in people with Disorder of Consciousness and Traumatic Brain Injury, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some Minimally Conscious State (MCS) patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorder of Consciousness, Traumatic Brain Injury, Anoxic Brain Injury
- What is being tested?
- Coma Recovery Scale - revised and Electrophysiological recordings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Sep 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years
- Disorder of consciousness assessed by CRS-R (VS, MCS, exitMCS)
- Patients with stable clinical examination (even in intensive care unit)
- Structural brain injury confirmed by cerebral imaging (MRI or TDM)
Who cannot join
- Refractory status epilepticus
- Known preexisting severe neurodegenerative disease (ie: Alzheimer disease, Lewy body dementia, ...)
- MRI contraindication: metallic intra-cranial implants, pacemaker or implantable cardioverter-defibrillator, cranial prosthesis
- Pregnant, parturient or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sub-study of the NEURODOC Project (Electrophysiological Evaluation of Consciousness in Patients With Disorders of Consciousness During Standard Care Procedures): Neurophysiological Evaluation of a Routine Care Open Label tDCS Session
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some Minimally Conscious State (MCS) patients, and in some Vegetative State (VS) patients.
However the mechanisms by which tDCS improves consciousness are poorly understood and the electrophysiological effects of such a stimulation have never been studied in disorders of consciousness patients.
In this study, the investigators will use detailed clinical examinations and electrophysiological assessments (quantitative high-density EEG and event-related potentials) to assess the effect of a open-label single session of left dorsolateral prefrontal cortex tDCS stimulation administered as routine care.
Read the detailed description
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some Minimally Conscious State (MCS) patients, and in some Vegetative State (VS) patients (1, 2, 3, 4), with no side effects reported.
However the mechanisms by which tDCS improves consciousness are poorly understood and the electrophysiological effects of the stimulation have never been studied in disorders of consciousness patients.
In this study, the investigators will use detailed clinical examinations (Coma Recovery Scale - Revised (5)) and electrophysiological assessments (quantitative high-density EEG and event-related potentials) (6, 7) and event-related potentials (8, 9) together with a standard morphological MRI to assess the effect of a open-label single session of left dorsolateral prefrontal cortex tDCS stimulation administered as routine care.
The primary goal is to investigate electrophysiological response to tDCS and its relation to behavioral response to better understand how tDCS affects consciousness in disorders of consciousness patients.
References:
- Angelakis, E. et al. Transcranial Direct Current Stimulation Effects in Disorders of Consciousness. Arch. Phys. Med. Rehabil. 95, 283-289 (2014).
- Thibaut, A., Bruno, M.-A., Ledoux, D., Demertzi, A. \& Laureys, S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology 82, 1112-1118 (2014).
- Thibaut, A. et al. Controlled clinical trial of repeated prefrontal tDCS in patients with chronic minimally conscious state. Brain Inj. 1-9 (2017). doi:10.1080/02699052.2016.1274776
- Martens, G. et al. Randomized controlled trial of home-based 4-week tDCS in chronic minimally conscious state. Brain Stimulat. (2018). doi:10.1016/j.brs.2018.04.021
- Giacino, J. T. \& Kalmar, K. Diagnostic and prognostic guidelines for the vegetative and minimally conscious states. Neuropsychol. Rehabil. 15, 166-174 (2005).
- Sitt, J. D. et al. Large scale screening of neural signatures of consciousness in patients in a vegetative or minimally conscious state. Brain 137, 2258-2270 (2014).
- Engemann, D. A. et al. Robust EEG-based cross-site and cross-protocol classification of states of consciousness. Brain J. Neurol. 141, 3179-3192 (2018).
- Bekinschtein, T. A. et al. Neural signature of the conscious processing of auditory regularities. Proc. Natl. Acad. Sci. 106, 1672-1677 (2009).
- Faugeras, F. et al. Event related potentials elicited by violations of auditory regularities in patients with impaired consciousness. Neuropsychologia 50, 403-418 (2012).
- Being tested
- Coma Recovery Scale - revised, Electrophysiological recordings
- Keywords
- Disorders of consciousness, Transcranial direct current stimulation, Electroencephalography, Electrophysiological signatures of consciousness, Coma Recovery Scale - Revised
- Medical subject headings
- Consciousness Disorders, Brain Injuries, Traumatic, Hypoxia-Ischemia, Brain, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coma Recovery Scale - revisedBehavioural
Also called CRS-R
Assessment of the level of consciousness by the dedicated Coma Recovery Scale - Revised, current gold-standard in consciousness level assessment.
Assessment before and after the tDCS session (immediately before and after the electrophysiological assessment, see below).
Electrophysiological recordingsDiagnostic test
Also called EEG
The electrophysiological assessment consisted of:
- a 5 minutes resting state high-density EEG recording
- a approximately 6 minutes auditory oddball paradigm These two procedures were administered immediately before and after the tDCS session
| Study group | Role | What they receive |
|---|---|---|
| Clinical and electrophysiological evaluation of tDCS session | Experimental | In this prospective case-control study, the investigator's main goal was to evaluate the impact of a single standard-care tDCS session on brain activity (EEG).
The effect of a single 20 minutes 2 mA tDCS session with the anode placed over the left dorsolateral prefrontal cortex and the cathode over the right supraorbital cortex administered as routine care were evaluated by combined behavioral and electrophysiological assessments immediately before and after the stimulation.
The study consisted of the following interventions, administered immediately before and after the stimulation session:
* detailed behavioral assessment by the Coma Recovery Scale-Revised (CRS-R)
* 5 minutes resting state high-density EEG recordings and 6 minutes auditory oddball paradigm immediately.
Additionally, clinical anatomical MRI (T1) acquired as routine care were used to model the estimated tDCS-induced electric fields in the entire head of patients, based on available T1-weighted MRI. Receives: Behavioral: Coma Recovery Scale - revised; Diagnostic Test: Electrophysiological recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Support vector machine multivariate prediction of consciousness from resting state EEG markers
Change from baseline of the predicted probability of conscious state, ie. to be classified a in a 'minimally conscious state' as opposed to be classified as in a 'vegetative state'.
The prediction will be based on a set of markers extracted from the EEG (power spectra, information theory, complexity and connectivity markers) and will use a support vector machine classifier algorithm train on a validated database. See Sitt et al., Brain et al. 2014. for details on the EEG preprocessing, markers extraction, support vector machine algorithm and training database.
Measured: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)
Evoked response potential during auditory oddball paradigm
Change of the Evoked Response Potentials recorded during the auditory oddball paradigm
Measured: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)
Secondary outcomes (2)
Resting state EEG individual markers
In addition to the multivariate classification from the EEG, the response to stimulation will be evaluated on several quantitative markers derived from the EEG: power spectrum, complexity and connectivity assessed by the weighted symbolic mutual information (King \& Sitt, Current Biology 2013; Sitt, Brain 2014; Engemann \& Raimondo, Brain 2018)
Measured: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)
State of consciousness
Change of the Coma Recovery Scale-Revised scores (CRS-R, Giacino et al. Neurology 2002 and Kalmar et al., Neuropsychol Rehabil 2005) between before and after stimulation (CRS-R post stimulation - CRS-R before stimulation). The CRS-R score is a qualitative and quantitative scales ranking predefined behaviors elicited by the patients in the following six subscales, auditory function, visual function, motor function, verbal and oromotor function, communication and wakefulness, the sum of which give a total score ranging from 0 to 23. Higher values of the scale mean a better state of consciousness.
Measured: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study startOct 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Electrophysiological evaluation of a routine care intervention: single session of left dorso-lateral transcranial direct current stimulation
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIONEL NACCACHE, Groupe Hospitalier Pitie-Salpetriere
- Investigators
- Lionel Naccache, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035655
- Sponsor's protocol ID
- 2013-A01385-40
- Acronym
- Neurodoc
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Angelakis E, Liouta E, Andreadis N, Korfias S, Ktonas P, Stranjalis G, Sakas DE. Transcranial direct current stimulation effects in disorders of consciousness. Arch Phys Med Rehabil. 2014 Feb;95(2):283-9. doi: 10.1016/j.apmr.2013.09.002. Epub 2013 Sep 11.
PubMed 24035769Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26.
PubMed 24574549Thibaut A, Wannez S, Donneau AF, Chatelle C, Gosseries O, Bruno MA, Laureys S. Controlled clinical trial of repeated prefrontal tDCS in patients with chronic minimally conscious state. Brain Inj. 2017;31(4):466-474. doi: 10.1080/02699052.2016.1274776. Epub 2017 Mar 10.
PubMed 28281845Martens G, Lejeune N, O'Brien AT, Fregni F, Martial C, Wannez S, Laureys S, Thibaut A. Randomized controlled trial of home-based 4-week tDCS in chronic minimally conscious state. Brain Stimul. 2018 Sep-Oct;11(5):982-990. doi: 10.1016/j.brs.2018.04.021. Epub 2018 May 2.
PubMed 29759943Giacino JT, Kalmar K. Diagnostic and prognostic guidelines for the vegetative and minimally conscious states. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):166-74. doi: 10.1080/09602010443000498.
PubMed 16350959Sitt JD, King JR, El Karoui I, Rohaut B, Faugeras F, Gramfort A, Cohen L, Sigman M, Dehaene S, Naccache L. Large scale screening of neural signatures of consciousness in patients in a vegetative or minimally conscious state. Brain. 2014 Aug;137(Pt 8):2258-70. doi: 10.1093/brain/awu141. Epub 2014 Jun 11.
PubMed 24919971Engemann DA, Raimondo F, King JR, Rohaut B, Louppe G, Faugeras F, Annen J, Cassol H, Gosseries O, Fernandez-Slezak D, Laureys S, Naccache L, Dehaene S, Sitt JD. Robust EEG-based cross-site and cross-protocol classification of states of consciousness. Brain. 2018 Nov 1;141(11):3179-3192. doi: 10.1093/brain/awy251.
PubMed 30285102Bekinschtein TA, Dehaene S, Rohaut B, Tadel F, Cohen L, Naccache L. Neural signature of the conscious processing of auditory regularities. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1672-7. doi: 10.1073/pnas.0809667106. Epub 2009 Jan 21.
PubMed 19164526Faugeras F, Rohaut B, Weiss N, Bekinschtein T, Galanaud D, Puybasset L, Bolgert F, Sergent C, Cohen L, Dehaene S, Naccache L. Event related potentials elicited by violations of auditory regularities in patients with impaired consciousness. Neuropsychologia. 2012 Feb;50(3):403-18. doi: 10.1016/j.neuropsychologia.2011.12.015. Epub 2012 Jan 3.
PubMed 22230230
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-study of the NEURODOC Project (Electrophysiological Evaluation of Consciousness in Patients With Disorders of Consciousness During Standard Care Procedures): Neurophysiological Evaluation of a Routine Care Open Label tDCS Session
- ClinicalTrials.gov ID
- NCT04035655
- Acronym / sponsor ID
- Neurodoc / 2013-A01385-40
- Keywords
- Disorders of consciousness, Transcranial direct current stimulation, Electroencephalography, Electrophysiological signatures of consciousness, Coma Recovery Scale - Revised
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 29 Jul 2019 (actual)
- 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.
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some Minimally Conscious State (MCS) patients, and in some Vegetative State (VS) patients.
However the mechanisms by which tDCS improves consciousness are poorly understood and the electrophysiological effects of such a stimulation have never been studied in disorders of consciousness patients.
In this study, the investigators will use detailed clinical examinations and electrophysiological assessments (quantitative high-density EEG and event-related potentials) to assess the effect of a open-label single session of left dorsolateral prefrontal cortex tDCS stimulation administered as routine care.
Detailed description
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some Minimally Conscious State (MCS) patients, and in some Vegetative State (VS) patients (1, 2, 3, 4), with no side effects reported.
However the mechanisms by which tDCS improves consciousness are poorly understood and the electrophysiological effects of the stimulation have never been studied in disorders of consciousness patients.
In this study, the investigators will use detailed clinical examinations (Coma Recovery Scale - Revised (5)) and electrophysiological assessments (quantitative high-density EEG and event-related potentials) (6, 7) and event-related potentials (8, 9) together with a standard morphological MRI to assess the effect of a open-label single session of left dorsolateral prefrontal cortex tDCS stimulation administered as routine care.
The primary goal is to investigate electrophysiological response to tDCS and its relation to behavioral response to better understand how tDCS affects consciousness in disorders of consciousness patients.
References:
- Angelakis, E. et al. Transcranial Direct Current Stimulation Effects in Disorders of Consciousness. Arch. Phys. Med. Rehabil. 95, 283-289 (2014).
- Thibaut, A., Bruno, M.-A., Ledoux, D., Demertzi, A. \& Laureys, S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology 82, 1112-1118 (2014).
- Thibaut, A. et al. Controlled clinical trial of repeated prefrontal tDCS in patients with chronic minimally conscious state. Brain Inj. 1-9 (2017). doi:10.1080/02699052.2016.1274776
- Martens, G. et al. Randomized controlled trial of home-based 4-week tDCS in chronic minimally conscious state. Brain Stimulat. (2018). doi:10.1016/j.brs.2018.04.021
- Giacino, J. T. \& Kalmar, K. Diagnostic and prognostic guidelines for the vegetative and minimally conscious states. Neuropsychol. Rehabil. 15, 166-174 (2005).
- Sitt, J. D. et al. Large scale screening of neural signatures of consciousness in patients in a vegetative or minimally conscious state. Brain 137, 2258-2270 (2014).
- Engemann, D. A. et al. Robust EEG-based cross-site and cross-protocol classification of states of consciousness. Brain J. Neurol. 141, 3179-3192 (2018).
- Bekinschtein, T. A. et al. Neural signature of the conscious processing of auditory regularities. Proc. Natl. Acad. Sci. 106, 1672-1677 (2009).
- Faugeras, F. et al. Event related potentials elicited by violations of auditory regularities in patients with impaired consciousness. Neuropsychologia 50, 403-418 (2012).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Electrophysiological evaluation of a routine care intervention: single session of left dorso-lateral transcranial direct current stimulation
| Arm | Type | Receives |
|---|---|---|
| Clinical and electrophysiological evaluation of tDCS session | Experimental | Behavioral: Coma Recovery Scale - revised, Diagnostic Test: Electrophysiological recordingsIn this prospective case-control study, the investigator's main goal was to evaluate the impact of a single standard-care tDCS session on brain activity (EEG). The effect of a single 20 minutes 2 mA tDCS session with the anode placed over the left dorsolateral prefrontal cortex and the cathode over the right supraorbital cortex administered as routine care were evaluated by combined behavioral and electrophysiological assessments immediately before and after the stimulation. The study consisted of the following interventions, administered immediately before and after the stimulation session: * detailed behavioral assessment by the Coma Recovery Scale-Revised (CRS-R) * 5 minutes resting state high-density EEG recordings and 6 minutes auditory oddball paradigm immediately. Additionally, clinical anatomical MRI (T1) acquired as routine care were used to model the estimated tDCS-induced electric fields in the entire head of patients, based on available T1-weighted MRI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years
- Disorder of consciousness assessed by CRS-R (VS, MCS, exitMCS)
- Patients with stable clinical examination (even in intensive care unit)
- Structural brain injury confirmed by cerebral imaging (MRI or TDM)
Key exclusion criteria (4 listed)
- Refractory status epilepticus
- Known preexisting severe neurodegenerative disease (ie: Alzheimer disease, Lewy body dementia, ...)
- MRI contraindication: metallic intra-cranial implants, pacemaker or implantable cardioverter-defibrillator, cranial prosthesis
- Pregnant, parturient or breastfeeding women
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 |
|---|---|---|
| Coma Recovery Scale - revisedAlso: CRS-RAssessment of the level of consciousness by the dedicated Coma Recovery Scale - Revised, current gold-standard in consciousness level assessment. Assessment before and after the tDCS session (immediately before and after the electrophysiological assessment, see below). | Behavioural | Clinical and electrophysiological evaluation of tDCS session |
| Electrophysiological recordingsAlso: EEGThe electrophysiological assessment consisted of: * a 5 minutes resting state high-density EEG recording * a approximately 6 minutes auditory oddball paradigm These two procedures were administered immediately before and after the tDCS session | Diagnostic test | Clinical and electrophysiological evaluation of tDCS session |
Primary outcome
Support vector machine multivariate prediction of consciousness from resting state EEG markers
Time frame: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)
Change from baseline of the predicted probability of conscious state, ie. to be classified a in a 'minimally conscious state' as opposed to be classified as in a 'vegetative state'. The prediction will be based on a set of markers extracted from the EEG (power spectra, information theory, complexity and connectivity markers) and will use a support vector machine classifier algorithm train on a validated database. See Sitt et al., Brain et al. 2014. for details on the EEG preprocessing, markers extraction, support vector machine algorithm and training database.
Evoked response potential during auditory oddball paradigm
Time frame: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)
Change of the Evoked Response Potentials recorded during the auditory oddball paradigm
2 secondary outcomes
Resting state EEG individual markers
Time frame: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)
State of consciousness
Time frame: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)
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 29 Jul 2019.
- Background: PubMed 24035769Angelakis E, Liouta E, Andreadis N, Korfias S, Ktonas P, Stranjalis G, Sakas DE. Transcranial direct current stimulation effects in disorders of consciousness. Arch Phys Med Rehabil. 2014 Feb;95(2):283-9. doi: 10.1016/j.apmr.2013.09.002. Epub 2013 Sep 11.
- Background: PubMed 24574549Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26.
- Background: PubMed 28281845Thibaut A, Wannez S, Donneau AF, Chatelle C, Gosseries O, Bruno MA, Laureys S. Controlled clinical trial of repeated prefrontal tDCS in patients with chronic minimally conscious state. Brain Inj. 2017;31(4):466-474. doi: 10.1080/02699052.2016.1274776. Epub 2017 Mar 10.
- Background: PubMed 29759943Martens G, Lejeune N, O'Brien AT, Fregni F, Martial C, Wannez S, Laureys S, Thibaut A. Randomized controlled trial of home-based 4-week tDCS in chronic minimally conscious state. Brain Stimul. 2018 Sep-Oct;11(5):982-990. doi: 10.1016/j.brs.2018.04.021. Epub 2018 May 2.
- Background: PubMed 16350959Giacino JT, Kalmar K. Diagnostic and prognostic guidelines for the vegetative and minimally conscious states. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):166-74. doi: 10.1080/09602010443000498.
- Background: PubMed 24919971Sitt JD, King JR, El Karoui I, Rohaut B, Faugeras F, Gramfort A, Cohen L, Sigman M, Dehaene S, Naccache L. Large scale screening of neural signatures of consciousness in patients in a vegetative or minimally conscious state. Brain. 2014 Aug;137(Pt 8):2258-70. doi: 10.1093/brain/awu141. Epub 2014 Jun 11.
- Background: PubMed 30285102Engemann DA, Raimondo F, King JR, Rohaut B, Louppe G, Faugeras F, Annen J, Cassol H, Gosseries O, Fernandez-Slezak D, Laureys S, Naccache L, Dehaene S, Sitt JD. Robust EEG-based cross-site and cross-protocol classification of states of consciousness. Brain. 2018 Nov 1;141(11):3179-3192. doi: 10.1093/brain/awy251.
- Background: PubMed 19164526Bekinschtein TA, Dehaene S, Rohaut B, Tadel F, Cohen L, Naccache L. Neural signature of the conscious processing of auditory regularities. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1672-7. doi: 10.1073/pnas.0809667106. Epub 2009 Jan 21.
- Background: PubMed 22230230Faugeras F, Rohaut B, Weiss N, Bekinschtein T, Galanaud D, Puybasset L, Bolgert F, Sergent C, Cohen L, Dehaene S, Naccache L. Event related potentials elicited by violations of auditory regularities in patients with impaired consciousness. Neuropsychologia. 2012 Feb;50(3):403-18. doi: 10.1016/j.neuropsychologia.2011.12.015. Epub 2012 Jan 3.
- Individual participant dataSharing planned: No
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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.
Lionel Naccache, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coma Recovery Scale - revised and Electrophysiological recordings in people with Disorder of Consciousness and Traumatic Brain Injury, run by Groupe Hospitalier Pitie-Salpetriere at 1 site 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 4 inclusion and 4 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 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Support vector machine multivariate prediction of consciousness from resting state EEG markers (time frame: Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)). The study lists 2 primary outcomes in all. 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 NCT04035655, which also lists 9 linked publications.
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 29 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.