Not Yet RecruitingNot Applicable

NEURO - Prognostication Using Late Somatosensory Evoked - Potentials

France50 participantsStarted 2026-06-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses something called 'late somatosensory evoked potentials' to help predict recovery in comatose patients — can you explain what that test involves and whether it might give us more information about what to expect compared to the standard assessments you're already using?
2The study is measuring EEG patterns, CRS-R scores, and Glasgow scores — are any of these tests already part of my loved one's current monitoring, and how might participating in this study add to or change what's being done?
3Since this trial hasn't started recruiting yet, is there a similar or currently active study we could look into now, or would it be worth waiting to see if this one opens at a center near us?
4This is listed as a prognostication study rather than a treatment trial, which means it's focused on predicting outcomes rather than changing them — does that mean participation wouldn't affect the care my loved one receives, and is that something we should factor into our decision?
5Given that the goal is improving prognosis accuracy in comatose patients in critical care, how would the findings from this study actually influence treatment decisions, and is there any potential burden or risk to the patient from the additional testing involved?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Alterations in the electroencephalogram

Timeframe: 3 weeks after inclusion

CRS-R score

Timeframe: 3 weeks after inclusion

Glasgow score

Timeframe: 3 weeks after inclusion

Trial details

NCT IDNCT07506928

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-31

Contact for this trial

Geoffroy MOUCHEBOEUF, MD

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

View on ClinicalTrials.gov More Comatose trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.