NEURO - Prognostication Using Late Somatosensory Evoked - Potentials

NCT07506928 | Not Yet Recruiting

• 1 other identifier: CHUBX 2025/053
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Comatose; Prognosis; Critical Care

Keywords

Prognostication; Somatosensory evoked - potentials; Neurocritical care; Machine learning; Continuous EEG

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• GOS-E

  6 months after inclusion

• SF36

  6 months after inclusion

Study Arms (1)

Patient

EXPERIMENTAL

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

Interventions

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.

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Inria, the French National Institute for computer science and applied mathematics: collaborator

Study Sites (1)

Bordeaux university hospital

Bordeaux, Nouvelle-Aquitaine, 33000, France

Location

MeSH Terms

Conditions

Coma

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Geoffroy MOUCHEBOEUF, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Grégoire CANE, MD

  University Hospital, Bordeaux

  STUDY DIRECTOR

• Fabien LOTTE

  Institut National de Recherche en Informatique et en Automatique

  STUDY CHAIR

Central Study Contacts

Geoffroy MOUCHEBOEUF, MD

CONTACT

05 57 82 19 95; geoffroy.moucheboeuf@chu-bordeaux.fr

Grégoire CANE, MD

CONTACT

gregoire.cane@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This prospective interventional study involves the use of passive somaesthetic stimulation, which is defined as painless electrical stimulation of the median nerve, in conjunction with electroencephalogram (EEG) recordings. The study is being conducted in a single centre, specifically the neuro-resuscitation department of the Pellegrin Hospital in Bordeaux

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 2, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)