NEURO - Prognostication Using Late Somatosensory Evoked - Potentials

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 media

Первичные конечные точки

• Alterations in the electroencephalogram [Срок оценки: 3 weeks after inclusion]
• CRS-R score [Срок оценки: 3 weeks after inclusion]
• Glasgow score [Срок оценки: 3 weeks after inclusion]

Вторичные конечные точки (2)

• GOS-E [Срок оценки: 6 months after inclusion]
• SF36 [Срок оценки: 6 months after inclusion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Bordeaux university hospital — Bordeaux

Идентификаторы

NCT: NCT07506928 · CHUBX 2025/053

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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