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New electrode method could spot hidden brain damage early

NCT ID NCT04585503

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether implanting special electrodes on the brain's surface can safely detect spreading depolarizations—electrical waves that may signal new damage after severe head trauma or brain hemorrhage. Twenty patients in intensive care received these electrodes alongside standard monitoring. The goal was to see if the electrodes could provide clear signals for at least 12 hours, potentially allowing doctors to intervene earlier.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better ways to monitor brain injury progression and prevent further damage in intensive care.
What could go wrong
This is a very small feasibility study (20 patients) focused on safety and signal quality, not treatment. It may not lead to clinical benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Jan 2021

Finished

Apr 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient \> 18 year old * Patients admitted in neurological reanimation unit for brain lesions after severe head trauma or subarachnoid hemorrhage and requesting a intracranial monitoring or a surgery (evacuation of a hematoma, treatment of an aneurysm, external ventricular bypass). * Patients affiliated to a social security system * Patient having been informed and having signed the Consent form OR Close to the patient who has been informed and signed the Consent form OR third party certificate then close consent for further study. Exclusion Criteria: * Patient with scalp acute infection * Pregnant or nursing women * Contre-indication to intracranial surgery * Patient with not corrected coagulation disorder * Patient treated with NSAIDS * Patient treated with under platelet antiaggregants * Patient under legal protection, guardianship, curators * patients under legal protection * Patient participating in a study who may interfere with this study. * people under duress psychiatric care,

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Conditions

The condition(s) this trial relates to.

Craniocerebral Trauma head injury subarachnoid hemorrhage traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain lesion Head trauma Subarachnoid hemorrhage

Contacts and locations

Locations

  • Service d'Anesthésie réanimation Groupement hospitalier Est, hôpital Pierre Wertheimer

    Bron, 69500, France

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