AI-Powered MRI could spot dangerous brain swelling after stroke
NCT ID NCT07789990
First seen Aug 27, 2026 · Last updated Sep 02, 2026 · Updated 3 times
Summary
This study tests whether a high-powered 7T MRI can measure sodium levels in the brain tissue around a bleeding stroke, and whether a drop in sodium predicts worse swelling and disability. Researchers will also use an AI algorithm to create similar sodium maps from standard 3T MRI scans, so the technique could work in hospitals without the ultra-high-field machine. The study enrolls 48 adults who had a bleeding stroke within the past 8 days and follows their recovery for 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Synthetic sodium imaging using MRI (7T and 3T) with an AI algorithm to generate sodium concentration maps
- What this could lead to
- If it works, this could give hospitals a way to predict which stroke patients are at risk of severe brain swelling and poor recovery, using standard MRI machines.
- What could go wrong
- This is an early imaging study with 48 participants, so the AI-generated maps may not match the 7T scans closely enough, and the link to recovery is still unproven.
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
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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
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Patients aged between 18 and 80 years old; * presenting for a first-ever or recurrent symptomatic supratentorial spontaneous ICH within 8 (±2) days after symptoms onset (or last seen well) and confirmed by brain imaging; presumed to be related to small vessel disease. * Patient/legal representative/trusted person who has given written consent to participate in the trial; * Patient covered by social security in France * Patient willing to comply with all study procedures and its duration Exclusion Criteria: * Contra-indication for MRI; * pre-admission disabilities (mRs \> 4); * large ICH of 60 ml or more; * NIH Stroke Scale score \> 20; * item 1a of NIH Stroke Scale (level consciousness) \> 0; * surgical evacuation of ICH, associated intraventricular haemorrhage; ICH due to preceding trauma; ICH suspected to result from an identified intracranial vascular malformation, intracranial venous thrombosis, tumor or haemorrhagic transformation within an infarct. * Epileptic seizure within 48 hours prior to inclusion or anti-epileptic treatment * Patient in the intensive care unit who is intubated and on a ventilator * Pregnancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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The official record
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