A new brain monitor could reveal stroke outcomes in minutes
NCT ID NCT07747701
First seen Aug 05, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This study tests whether a bedside monitoring device, placed on the head right after a mechanical thrombectomy for acute ischemic stroke, can predict which patients will have poor neurological outcomes. The device uses near-infrared spectroscopy to measure brain oxygen levels and blood pressure for about 30 minutes, calculating a cerebral oxygenation index. Researchers will follow 227 patients for up to 90 days to see if this early monitoring can identify those at risk of disability or death, potentially guiding faster, more personalized care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NIRS-based cerebral oxygenation and blood pressure monitoring device
- What this could lead to
- If successful, this monitoring approach could help doctors identify stroke patients at risk of poor recovery within minutes after treatment, enabling earlier interventions and better outcomes.
- What could go wrong
- This is an early-stage diagnostic study, and the monitoring technique may not reliably predict outcomes in all patients. Its accuracy and clinical benefit remain unproven until larger studies confirm the findings.
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 227 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jul 2026
An estimate. Start dates often move.
- Expected to finish
-
Feb 2027
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 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 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: 1. Age ≥ 18 2. Diagnosis of acute ischemic stroke caused by anterior circulation large vessel occlusion (intracranial internal carotid artery or M1 segment of the middle cerebral artery). 3. National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 at presentation. 4. Pre-stroke modified Rankin Scale (mRS) score ≤ 1. 5. Symptom onset ≤ 24 hours. 6. For patients with symptom onset within 6 hours: ASPECTS ≥ 6; for patients with symptom onset between 6 and 24 hours: age ≤ 80 years and ASPECTS ≥ 3. 7. Underwent mechanical thrombectomy and achieved successful recanalization (mTICI 2b-3). 8. Patient or legally authorized representative provides written informed consent. Exclusion Criteria: 1. Pre-procedural baseline imaging showing significant intracranial hemorrhagic transformation, intracranial arterial dissection, large chronic cerebral infarction, or intracranial metastasis from malignant tumors. 2. Any degree of stenosis, plaque, dissection, severe tortuosity, or imaging evidence of unstable/vulnerable plaque in the target-side or bilateral common carotid artery or the origin of the internal carotid artery. 3. Known history of carotid sinus hypersensitivity syndrome, severe autonomic dysfunction, sick sinus syndrome, high-grade atrioventricular conduction block, or other malignant arrhythmias. 4. Refractory malignant hypertensive crisis (systolic blood pressure persistently ≥ 200 mmHg despite standardized intravenous antihypertensive therapy, or hemodynamic instability with shock). 5. Known severe allergy to contrast agents or anesthetic drugs, or contraindications to antiplatelet/anticoagulation therapy. 6. Severe systemic active infection, multiple organ failure, or expected survival \< 6 months. 7. Severe hepatic or renal dysfunction (ALT/AST \> 3× upper limit of normal; estimated glomerular filtration rate \< 30 mL/min) or severe coagulation disorders (platelet count \< 40 × 10⁹/L, APTT \> 50 s, INR \> 3.0). 8. Blood glucose \< 2.7 mmol/L or \> 22.2 mmol/L. 9. Heart failure with NYHA class \> II, or persistent systolic blood pressure \< 100 mmHg. 10. Central nervous system infection or intracranial tumor. 11. Unstable vital signs. 12. Severe alcohol dependence or drug dependence. 13. Cognitive impairment or psychiatric disorders that may affect follow-up assessments. 14. Pregnant or breastfeeding women. 15. Participation in another clinical drug or device study within the past 30 days. 16. Local skin damage or other conditions preventing proper placement of monitoring electrodes. 17. Severe agitation or other conditions that interfere with data acquisition. 18. Any other condition judged by investigators to potentially affect study results.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute ischemic stroke are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
4 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Beijing Shijitan Hospital, Capital Medical University
RECRUITINGBeijing, China
-
Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)
NOT_YET_RECRUITINGDalian, China
-
The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITINGHeilongjiang, China
-
Weifang People's Hospital Affiliated to Weifang Medical University
RECRUITINGShandong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better