Chilled magnesium may boost stroke recovery in new trial
NCT ID NCT07163299
First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 3 times
Summary
This study tests whether infusing a cold magnesium sulfate solution directly into the brain during emergency clot removal can improve outcomes for people with acute ischemic stroke. About 42 adults aged 18-80 with severe strokes will be randomly assigned to receive either standard clot removal alone or clot removal plus the cold infusion. The main goal is to see if the treatment is safe and helps more people regain independence within 90 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- magnesium sulfate
- What this could lead to
- If it works, this could point toward a new way to protect the brain during stroke treatment, potentially reducing long-term disability.
- What could go wrong
- This is an early phase 1/2 trial with only 42 people, so results may not apply broadly. The infusion could cause side effects like heart rhythm changes or low body temperature.
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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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Mar 2027
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: 1. Age range of 18-80 years old (including critical value); 2. No gender restrictions; 3. The clinical diagnosis is acute ischemic stroke of the anterior circulation, and the site of acute occlusion of the responsible vessel is located in the intracranial segment of the internal carotid artery and the M1 or M2 segment of the middle cerebral artery; 4. The symptoms and signs are consistent with acute anterior circulation ischemic stroke, NIHSS≥6; 5. The time from onset to endovascular thrombectomy of acute ischemic stroke is within 24 hours; 6. Indications for endovascular thrombectomy of acute ischemic stroke: ① ASPECTS score ≥ 6 points, within 6 hours of onset; ② 6-16 hours after onset, meeting DEFUSE-3 criteria (infarct core volume \< 70 mL, mismatch rate ≥ 1.8 and mismatch volume \> 15 mL) or DAWN criteria (NIHSS ≥ 10 and infarct core volume \< 31 mL); Or NIHSS ≥ 20 and infarct volume 31-51 mL); ③ Within 16-24 hours of onset, meet DAWN criteria (NIHSS ≥ 10 points and infarct core volume \< 31mL); Or NIHSS ≥ 20 points and infarct volume 31-51 mL) 7. The mRS score before stroke is 0-1 points; 8. Written informed consent provided by the patients or their legal relatives. Exclusion Criteria: General exclusion criteria: 1. Clinical manifestations suggest the presence of intracranial cerebral parenchymal hemorrhage or subarachnoid hemorrhage (even if imaging results are normal); 2. During a stroke, accompanied by epilepsy, an accurate NIHSS score cannot be obtained; 3. Accompanied by coma or mental disorders, it may interfere with the assessment of neurological function; 4. History of allergy to iodinated contrast agents or history of anaphylactic shock; 5. Baseline blood glucose\<50mg/dL (2.78mmol) or\>400mg/dL (22.20mmol); \*Acceptable fingertip blood glucose results 6. Baseline platelet count\<50 × 10\^9/L; 7. Recently (i.e. within 30 days prior to inclusion in the study), there has been a history of significant gastrointestinal or other clinically significant bleeding; Active bleeding, abnormal coagulation factors, or bleeding tendency (taking anticoagulant drugs with INR ≥ 3 or PT ≥ 3 × ULN; if the researcher believes that the subject has no coagulation dysfunction, there is no need to wait for coagulation test results to determine whether to enroll); 8. During a stroke, there may be fever or active infections that require systemic treatment (such as active pulmonary tuberculosis); 9. History of chronic heart failure with NYHA criteria\>1; Uncontrolled hypertension (systolic blood pressure\>180mmHg or diastolic blood pressure\>105mmHg after standardized treatment), hypotension (systolic blood pressure ≤ 100mmHg after standardized treatment), unstable angina, myocardial infarction, or bypass or stent surgery within 6 months; 10. Accompanied by pulmonary diseases such as chronic obstructive pulmonary disease, tuberculosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, pleural effusion, acute respiratory distress syndrome, irregular breathing, etc; 11. Severe liver and kidney dysfunction, including but not limited to: cirrhosis, hepatic encephalopathy, ascites, renal failure or uremia (Ccr\<25ml/min), hepatorenal syndrome, etc; 12. Pregnant or lactating women; 13. Patients with acute stroke within 48 hours after percutaneous cardiovascular and cerebrovascular intervention and major surgery; 14. Currently participating in interventional clinical trials and using research drugs or medical devices; 15. Participants may not be able to complete this study due to other reasons or may not be considered eligible for inclusion by the researchers; Image exclusion criteria: 1. CTA/MRA/DSA shows excessive vessel curvature, which may hinder the delivery of interventional instruments; 2. Suspected cerebral vasculitis based on medical history and CTA/MRA/DSA; 3. Suspected aortic dissection based on medical history and CTA/MRA/DSA; 4. CTA/MRA/DSA confirmed multi vessel regional occlusion (such as bilateral anterior circulation or anterior/posterior circulation, extracranial carotid artery with intracranial tandem lesions), or clinical evidence of bilateral infarction or multi regional infarction; 5. CTA/MRA/DSA confirms moyamoya disease or moyamoya syndrome; 6. CT/MRI confirms significant effect of midline shift; 7. CT/MRI confirms the presence of intracranial tumors (excluding small meningiomas); 8. CT/MRI confirms the presence of intracranial hemorrhage.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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
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Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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