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Could keeping stroke patients cool improve recovery?

NCT ID NCT07096687

Disease control Sponsor: Azienda Usl di Bologna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study tests whether a device called CB240_Aurora, which monitors and adjusts body temperature, can help people recovering from a severe ischemic stroke. Twenty-two adults who have had a stroke within the last 48 hours will wear the device for 72 hours. Half will receive active temperature control to keep them in a normal range, while the other half will only have their temperature measured. Researchers will check if the device helps maintain normal temperature and improves recovery at 3 months.

What this could mean

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

Active substance
CB240_Aurora device (targeted temperature management)
What this could lead to
If it works, this could point toward a simple way to protect the brain during stroke recovery by keeping body temperature normal.
What could go wrong
This is a very small pilot study with only 22 people, so results may not apply widely. The device may not improve outcomes or could be uncomfortable.

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

About 22 people

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

Started

Sep 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Age \>18 years; * Both sexes; * Diagnosis of acute ischemic stroke confirmed by clinical evaluation by a neurologist and neuroimaging (CT or brain MRI); * Acute ischemic stroke with symptom onset within 48 hours; * Anterior circulation stroke with evidence on neuroimaging (CT angiography) of occlusion of the middle cerebral artery in segments M1, M2, or M3; * NIHSS score between 6 and 25; * First clinical stroke; * Axillary temperature ≥36°C and \<37°C; * Informed consent obtained for study participation. Exclusion Criteria: * Stroke involving multiple vascular territories; * Presence of intracerebral hemorrhage; * Pregnancy; * Moderate-to-severe or severe pre-stroke disability defined as mRS \>3; * Presence of a cardiac pacemaker or any other conditions contraindicating brain MRI.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

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

Ischemic stroke

How to take part

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

  1. The places running it

    1 site. 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

  • IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

    RECRUITING

    Bologna, Bologna, 40139, Italy

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