NCT06956521 · Baylor College of Medicine
Intra-Arterial Magnesium Therapy After Mechanical Thrombectomy in Acute Ischemic Stroke
What this study is about
The goal of this Phase I unblinded, gradually increasing doses trial is to evaluate the safety and how well patients handle the treatment of intra-arterial magnesium sulfate injection after mechanical thrombectomy in patients experiencing acute ischemic stroke.
View original scientific description
The goal of this Phase I unblinded, dose-escalation trial is to evaluate the safety and tolerability of intra-arterial magnesium sulfate injection after mechanical thrombectomy in patients experiencing acute ischemic stroke. This trial is one of the first trials to look at IA administration of magnesium sulfate into at risk brain tissue in a selective and localized fashion.
Interventions
DRUG
Magnesium sulfate
Following MT and IA injection of MgSO4, patients will also receive a continuous infusion of 16g MgSO4 diluted in 240 ml of 0.9% normal saline, infusing at a rate of 10 ml per hour for 24 hours.
Primary outcome measures
Systemic MgSO4 Concentration
Time frame: 6 hours post-MT, 24 hours post-MT
Proportion of severe adverse events
Time frame: 48 hours post-MT
severe adverse events including femoral artery dissection, local thrombosis, pseudoaneurysm, arteriovenous fistula, neurotoxicity and loss of reflexes due to magnesium, cardiovascular toxicity (arrythmias, severe bradycardia), respiratory depression
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient with acute cerebral ischemia due to ICA or MCA occlusion
- Major neurologic deficits: 6≤NIHSS≤20,
- Premorbid mRS 0 or 1, or 2
- Patient's clinical attending physician plans MT procedure as part of routine clinical care,
- undergo MT with a TICI 2a or better recanalization,
- Signed informed consent.
Exclusion criteria
- Positive pregnancy test;
- those undergoing MT with a TICI \<2a revascularization;
- tandem occlusion of the cervical common or internal carotid artery; and
- subjects on therapeutic anticoagulation, as it is a relative contraindication to MT, and could be a confounding variable predisposing to intracranial hemorrhage including coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia \<80000/mm3;
- Second or third-degree heart block without a pacemaker in place,
- Technical inability to navigate micro-catheter to target clot,
- Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy,
- mRS\>2 caused by a history of prior stroke,
- Severe hepatic dysfunction, severe renal dysfunction (\<30 mL/min), increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- Unsuitable for this clinical study assessed by researcher. Subjects will not be excluded if they received IV t-PA as standard of care.
- patient is on neuromuscular blocking agents including depolarizing (succinylcholine) and nondepolarizing subtypes (rocuronium, vecuronium, etc);
- patient is taking any form of CNS depressant including barbiturates, narcotics, outside the setting of anesthesia or ICU sedation
- patients taking digoxin or other cardiac glycoside
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2026 · Source of record for eligibility and locations