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A new brain monitor could reveal stroke outcomes in minutes

NCT ID NCT07747701

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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.

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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.

  1. The places running it

    4 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

  • Beijing Shijitan Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)

    NOT_YET_RECRUITING

    Dalian, China

  • The First Affiliated Hospital of Harbin Medical University

    NOT_YET_RECRUITING

    Heilongjiang, China

  • Weifang People's Hospital Affiliated to Weifang Medical University

    RECRUITING

    Shandong, China

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