Recruiting
Phase 1

Magnesium Sulfate

Sponsor:

Baylor College of Medicine

Code:

NCT06956521

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Magnesium sulfate

Study Details

Brief summary:

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.

Conditions

Acute Ischemic Stroke

Study ID

NCT06956521

Start date

Jul 1, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient with acute cerebral ischemia due to ICA or MCA occlusion
2. Major neurologic deficits: 6≤NIHSS≤20,
3. Premorbid mRS 0 or 1, or 2
4. Patient's clinical attending physician plans MT procedure as part of routine clinical care,
5. undergo MT with a TICI 2a or better recanalization,
6. Signed informed consent.

Exclusion Criteria:

1. Positive pregnancy test;
2. those undergoing MT with a TICI <2a revascularization;
3. tandem occlusion of the cervical common or internal carotid artery; and
4. 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;
5. Second or third-degree heart block without a pacemaker in place,
6. Technical inability to navigate micro-catheter to target clot,
7. Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy,
8. mRS>2 caused by a history of prior stroke,
9. 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;
10. Unsuitable for this clinical study assessed by researcher. Subjects will not be excluded if they received IV t-PA as standard of care.
11. patient is on neuromuscular blocking agents including depolarizing (succinylcholine) and nondepolarizing subtypes (rocuronium, vecuronium, etc);
12. patient is taking any form of CNS depressant including barbiturates, narcotics, outside the setting of anesthesia or ICU sedation
13. patients taking digoxin or other cardiac glycoside

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 0.25g Magnesium Sulfate

0.25g of magnesium sulfate (MgSO4) will be diluted in 0.9% sodium chloride for intra-arterial (IA) administration via the guide catheter already in place in the intracranial internal carotid artery (ICA) on the affected side for MT. The infusion will be administered over 1-2 minutes.

experimental: 0.5g Magnesium Sulfate

0.5g of magnesium sulfate (MgSO4) will be diluted in 0.9% sodium chloride for intra-arterial (IA) administration via the guide catheter already in place in the intracranial ICA on the affected side for MT. The infusion will be administered over 1-2 minutes.

experimental: 1.0g Magnesium Sulfate

1.0g of magnesium sulfate (MgSO4) will be diluted in 0.9% sodium chloride for intra-arterial (IA) administration via the guide catheter already in place in the intracranial ICA on the affected side for MT. The infusion will be administered over 1-2 minutes.

experimental: 1.5g Magnesium Sulfate

1.5g of magnesium sulfate (MgSO4) will be diluted in 0.9% sodium chloride for intra-arterial (IA) administration via the guide catheter already in place in the intracranial ICA on the affected side for MT. The infusion will be administered over 1-2 minutes.

Interventions

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 measure

  • Systemic MgSO4 Concentration [ Time Frame: 6 hours post-MT, 24 hours post-MT ]
  • Proportion of severe adverse events [ Time Frame: 48 hours post-MT ]

Central Contacts and Locations

Central contacts

Locations

Baylor St. Luke's Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Baylor College of Medicine

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • stroke
  • magnesium sulfate
  • neuroprotection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.