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NCT Number: NCT07506928

NEURO - Prognostication Using Late Somatosensory Evoked - Potentials

The main aim of this study is to develop a new technique for the passive diagnosis of cognitive-motor dissociation, with the detection of motor intention in a comatose patient by analysing the EEG signal and in particular the ERD/ERS amplitudes in the motor cortex after stimulation of the median nerve.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bordeaux university hospital

Bordeaux, New Aquitaine, 33000, France

Location contact

Geoffroy MOUCHEBOEUF, MD

CONTACT

[email protected]

0557821995 ext. +33

Grégoire CANE, MD

SUB_INVESTIGATOR

About this study

The utilisation of brain-computer interfaces (BCI) employing median nerve stimulation has the potential to yield novel insights into the enhancement of neuroprognostication. The application of painless, low-intensity electrical stimulation to the median nerve has been shown to activate the somatosensory cortex and the motor cortex via cutaneous and proprioceptive afferents. The activation in question has been shown to induce specific modulations of the electroencephalogram (EEG) signal, characterised by event-related desynchronisation (ERD) during stimulation, followed by resynchronisation (ERS) afterwards. The application of this stimulation during a motor task - that is to say, voluntary movement or motor imagery - results in a marked attenuation of post-stimulation ERS, or even its complete absence. The intention to move a hand, when coinciding with median nerve stimulation, amplifies the cortical ERD/ERS signatures, and is made more easily detectable by machine learning algorithms.

The main aim of this study is to develop a new technique for the passive diagnosis of cognitive-motor dissociation, with the detection of motor intention in a comatose patient by analysing the EEG signal and in particular the ERD/ERS amplitudes in the motor cortex after stimulation of the median nerve.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be aged 18 years or over;
  • Patients must be admitted to the intensive care unit with a cerebrovascular pathology;
  • Patients must be in a comatose state with a Glasgow score strictly less than 8, 24 hours after stopping sedation.
  • Representative of the patient informed of the research and not objecting to it, information and collection of the participant's non-objection if recovery of the ability to understand the content of the information note,
  • The patient is a recipient of or affiliated with a social security scheme.

Exclusion criteria

  • Bilateral lesions of the motor cortex or cortico-spinal fasciculus,
  • Cutaneous infection of the scalp or any other lesion making surface electroencephalography impossible,
  • Patient whose short-term survival (48 - 72 hours) seems compromised,
  • Severe peripheral neuromyopathy,
  • Severe Acute Respiratory Distress Syndrome at the time of screening,
  • Hearing-impaired patients with hearing aids,
  • Pregnant or breastfeeding woman,
  • Patient under legal protection (persons deprived of their liberty or under guardianship).

Treatment and study plan

EEGs

Other

All patients included in the study will receive electroencephalograms (EEGs) of post-stimulation event-related desynchronisation (ERD)/event-related synchronisation (ERS) amplitudes of the median nerve on two occasions per week. These recordings will be made twice a day, once in the morning and once in the afternoon/evening, in order to take account of the patients' inherent nycthemeral rhythm.

A recording of 12 EEG electrodes from the scalp will be made during painless stimulation of the median nerve. The intensity of this stimulation will range from 3 to 14 mA, with a duration of 0.1 ms and a frequency of 5 Hz. This will result in a multiplication of the recording periods during and after stimulation. A final period of approximately 15 minutes of recording will be carried out with headphones on the patient, using simple, pre-recorded, standardized commands. These recordings will be continued for a period of three weeks following their inclusion.

Primary outcomes

  1. Alterations in the electroencephalogram

    Time frame: 3 weeks after inclusion

    The alterations in the electroencephalogram (EEG) signal in the event-related desynchronisation/event-related synchronisation cortical signature following median nerve stimulation will be analysed and correlated with the emergence of clinical motor intention.

    The detection of cognitive-motor dissociation will rely on classification algorithms that detect the presence of motor activity in EEG signals following median nerve stimulation (MNS). The EEG signals recorded immediately after MNS will be represented as one or more covariance matrices, and several classifiers, including Riemannian classifiers, will then be trained on these matrices to classify a state of rest or motor activity in the EEG.

  2. CRS-R score

    Time frame: 3 weeks after inclusion

    Progression of the Clinical Rating Scale-Revised (CRS-R) score:

    Standardized clinical scale assessing level of consciousness across six subdomains: auditory, visual, motor, oromotor/verbal, communication, and arousal.

    Total score: 0 to 23

    Interpretation:

    Lower scores indicate absence or very low levels of consciousness (coma or vegetative state/unresponsive wakefulness syndrome).

    Intermediate scores indicate minimal but definite behavioral evidence of consciousness (minimally conscious state).

    Higher scores indicate more complex behaviors consistent with a higher level of consciousness (emergence from the minimally conscious state).

  3. Glasgow score

    Time frame: 3 weeks after inclusion

    Glasgow Coma Scale (GCS) Standardized clinical scale assessing level of consciousness based on three components: eye opening, verbal response, and motor response.

    Total score: 3 to 15

    Interpretation:

    Lower scores indicate severe impairment of consciousness (coma or deep unconsciousness).

    Intermediate scores indicate moderate impairment of consciousness. Higher scores indicate mild or no impairment of consciousness.

Secondary outcomes

  1. GOS-E

    Time frame: 6 months after inclusion

    The functional neurological prognosis in the period subsequent to the event will be evaluated by the Glasgow Outcome Scale-Extended (GOS-E) Standardized clinical scale assessing functional outcome and disability following brain injury, based on overall level of independence and social functioning.

    Total score: 1 to 8

    Interpretation:

    Lower scores indicate severe disability or death. Intermediate scores indicate moderate disability with some level of independence.

    Higher scores indicate good recovery with return to independent functioning.

  2. SF36

    Time frame: 6 months after inclusion

    The functional neurological prognosis in the period subsequent to the event will be evaluated by the Short Form-36 Health Survey (SF-36) Standardized patient-reported outcome measure assessing health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health.

    Score range: 0 to 100 for each domain (and summary scores)

    Interpretation:

    Lower scores indicate poorer health-related quality of life. Higher scores indicate better health-related quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Geoffroy MOUCHEBOEUF, MD

CONTACT

[email protected]

05 57 82 19 95 ext. +33

Grégoire CANE, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Inria, the French National Institute for computer science and applied mathematics

Registry information

Acronym: NEURO-PULSE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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