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Could induced hypothermia save brains after stubborn seizures?

NCT ID NCT07383779

Disease control Sponsor: Versailles Hospital 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether lowering body temperature to about 91°F for 24 hours improves brain recovery in adults with severe seizures that don't stop with standard medicines. About 466 people on breathing machines will be randomly assigned to cooling or normal temperature care. The goal is to see if cooling reduces brain damage and seizure activity within 90 days.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 466 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

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 to 65 years

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: * Age between 18 and 65 years \[18-65 years\] * Continued motor seizure activity lasting more than 5 minutes, or two or more motor seizures without a return to baseline level of consciousness in the interval at least 5 minutes after the first seizure * Refractory to two recommended antiseizure medications (benzodiazepine and "classic" antiseizure drug) * Receiving mechanical ventilation * Time from seizure onset no longer than 3.5 hours (210 min) * Consent to participate (patient's relative or emergent consent) Exclusion Criteria: * Estimated pre-morbid GOS-E score \< 5 * Preexisting ultimately fatal comorbidity \< 1 year * Patients unlikely to survive for the next 24 hours * Full recovery at time of inclusion * Need for emergent surgery or interventional neuroradiology for bleeding embolization (neurosurgery or other precluding therapeutic hypothermia) * Postanoxic status epilepticus * Traumatic Brain Injury with an acute bleeding on Computed Tomographic (CT) scan or Magnetic Resonance Imaging (MRI) of the brain * Bacterial meningitis as a cause of convulsive SE * Cryoglobulinemia, sickle cell disease, serum cold agglutinins comorbidities * Pregnancy * Absence of coverage by the French/European statutory healthcare insurance system

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Conditions

The condition(s) this trial relates to.

new-onset refractory status epilepticus Status Epilepticus

As listed by the trial registrant

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

Convulsive refractory status epilepticus Status epilepticus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH Annecy Genevois

    Metz-Tessy, France

  • CH Le Mans

    Le Mans, France

  • CH Melun-Sénart

    Melun, France

  • CH Simone Veil

    Cannes, France

  • CH Sud Francilien

    Corbeil-Essonnes, France

  • CH Versailles

    Le Chesnay, France

  • CHITS Toulon

    Toulon, France

  • CHR Orléans

    Orléans, France

  • CHU Brest

    Brest, France

  • CHU Dijon

    Dijon, France

  • CHU Nantes

    Nantes, France

  • CHU Rennes

    Rennes, France

  • GH Paris Saint-Joseph

    Paris, France

  • Hôpital Ambroise Paré

    Boulogne-Billancourt, France

  • Hôpital COCHIN

    Paris, France

  • Hôpital Edouard Herriot

    Lyon, France

  • Hôpital Foch

    Suresnes, France

  • Hôpital Hautepierre

    Strasbourg, France

  • Hôpital Louis Mourier

    Colombes, France

  • Hôpital de la Croix-Rousse

    Lyon, France

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