NEURO - Prognostication Using Late Somatosensory Evoked - Potentials (NEURO-PULSE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Care; Prognosis; Comatose
• Intervention / Treatment: Other: EEGs

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geoffroy MOUCHEBOEUF, MD; Phone Number: +33 05 57 82 19 95; Email: geoffroy.moucheboeuf@chu-bordeaux.fr
• Study Contact Backup: Name: Grégoire CANE, MD; Email: gregoire.cane@chu-bordeaux.fr

Study Locations

• France
  • Nouvelle-Aquitaine
    • Bordeaux, Nouvelle-Aquitaine, France, 33000
      • Bordeaux University Hospital
      • Sub-Investigator: Grégoire CANE, MD
      • Contact: Geoffroy MOUCHEBOEUF, MD; Phone Number: +33 0557821995; Email: geoffroy.moucheboeuf@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient; Patients admitted to the intensive care unit with a cerebrovascular pathology and in a comatose state with a Glasgow score strictly less than 8, 24 hours after stopping sedation.

Other: EEGs; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alterations in the electroencephalogram	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.	3 weeks after inclusion
CRS-R score	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 weeks after inclusion
Glasgow score	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.	3 weeks after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GOS-E	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.	6 months after inclusion
SF36	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.	6 months after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Inria, the French National Institute for computer science and applied mathematics
• Investigators: Study Director: Grégoire CANE, MD, University Hospital, Bordeaux; Principal Investigator: Geoffroy MOUCHEBOEUF, MD, University Hospital, Bordeaux; Study Chair: Fabien LOTTE, Institut National de Recherche en Informatique et en Automatique

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Machine learning; Prognostication; Neurocritical care; Continuous EEG; Somatosensory evoked - potentials
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Coma
• Other Study ID Numbers: CHUBX 2025/053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No