Traumatic Brain InjuriesPhase 4NCT07763665
Anti-inflammatory Effect of MgSO₄ in Patients With Moderate Traumatic Brain Injury by Measurming Nucleotide-binding Oligomerization Domain-Like Receptor Pyrin Domain-containing 3 (NLRP3) Inflammasome-a Multiprotein Complex
A Phase 4 study testing Magnesium sulfate (MgSO4) and Normal Saline in people with Traumatic Brain Injuries, run by Assiut University.
Trial summary
The primary objective of this study is to evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI) at Assiut University Hospitals by measuring Nucleotide-binding oligomerization domain-Like Receptor Pyrin… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injuries
- What is being tested?
- Magnesium sulfate (MgSO4) and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients aged 18 to 60 years.
- Sustained a closed head trauma with the study drug infusion initiated within 8 hours of the injury.
- TBI confirmed by history and clinical examination.
- Patients with moderate (GCS = 9-12) traumatic brain injury.
- Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification ).
- Hemodynamic stability at the time of enrollment.
Who cannot join
- Patient Refusal
- Prolonged and/or uncorrectable hypoxia (PaO₂ < 60 mmHg) or persistent hypotension (systolic blood pressure < 90 mmHg) at the time of randomization.
- Cardiopulmonary arrest.
- Concomitant spinal cord injury.
- Pregnant or lactating females.
- Penetrating head injury.
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- Associated other extra-cranial trauma or systemic polytrauma.
- Undergoing surgical interventions during the study.
- Pre-existing severe cardiac arrhythmia, heart block, or significant myocardial damage (documented on ECG).
- Known history of chronic renal failure or abnormal baseline renal function.
- Known hypersensitivity or allergic reaction to magnesium sulfate.
- Patients on chronic steroid therapy.
- BMI>35 kg/m2.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Anti-Inflammatory Effect of Magnesium Sulfate on the Outcomes of Patients With Moderate Traumatic Brain Injury.
The primary objective of this study is to evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI) at Assiut University Hospitals by measuring Nucleotide-binding oligomerization domain-Like Receptor Pyrin domain-containing 3 (NLRP3) inflammasome-a multiprotein complex.
Read the detailed description
Traumatic brain injury (TBI) remains a leading cause of mortality and long-term disability worldwide, disrupting both individual lives and healthcare systems. The pathophysiology of TBI is characterized by a biphasic process. The primary injury occurs at the moment of impact, resulting in immediate mechanical tissue disruption. This is followed by a complex cascade of cellular and molecular changes known as secondary brain injury, which develops hours to days later.
A cornerstone of this secondary injury pathway is neuroinflammation, driven by the activation of resident microglia and the infiltration of peripheral immune cells. Central to this inflammatory response is the assembly and activation of the Nucleotide-binding oligomerization domain-Like Receptor Pyrin domain-containing 3 (NLRP3) inflammasome-a multiprotein complex that triggers the maturation and release of potent pro-inflammatory cytokines, specifically interleukin-1β (IL-1β) and interleukin-18 (IL-18), accelerating neuronal apoptosis and blood-brain barrier dysfunction.
Magnesium sulfate (MgSO₄) has emerged as a promising neuroprotective candidate due to its multifaceted mechanism of action. Primarily, magnesium acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, thereby mitigating glutamate-mediated excitotoxicity. Emerging molecular evidence further indicates that magnesium exerts potent anti-inflammatory effects by downregulating nuclear factor kappa B (NF-κB) activation and directly inhibiting the assembly of the NLRP3 inflammasome. Consequently, evaluating the clinical and molecular efficacy of MgSO₄ in TBI patients could offer a viable therapeutic pathway to suppress secondary neuroinflammation and optimize neurological recovery.
NLRP3 Inflammasome is a multiprotein complex consisting of three core components:
- Sensor (NLRP3)
- Adaptor (ASC)
- Effector (Caspase-1)
Its activation is regulated by a two-signal framework:
- Priming (Signal 1): Activates the nuclear factor kappa B(NF-κB) pathway to produce baseline NLRP3 components and inactive proteins (Pro-IL-1β, P ro-IL-18 andPro-IL-6).
- Activation (Signal 2): Triggered by cellular stress signals (such as Ca 2+ influx, K efflux, and mitochondrial distress).
Active Caspase-1 processes cytokines into their potent active forms and triggers a inflammatory cell death.
Magnesium sulfate (MgSO₄) has emerged as a promising neuroprotective candidate.
Magnesium sulfate exerts potent anti-inflammatory effects that can inhibit NLRP3 Inflammasome activation through 4 mechanisms:
- downregulating nuclear factor kappa B (NF-κB) activation and directly inhibiting the assembly of the NLRP3 inflammasome
- preventing extracellular Ca2+ influx and intracellular release
- Reducing K Efflux
- Preserving Mitochondrial Integrity
- Conditions
- Traumatic Brain Injuries
- Being tested
- Magnesium sulfate (MgSO4), Normal Saline
- Keywords
- anti-inflammatory effect of magnesium sulfate
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfate (MgSO4)Drug
evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI)
Normal SalineDrug
evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI)
| Study group | Role | What they receive |
|---|---|---|
| Group (A): Will receive intravenous magnesium sulfate MgSO₄. | Experimental | 32 patients will receive
* Loading Dose: Administered within 8 hours of trauma at a dose of 50 mg/kg via IV infusion over 1 hour.
* Maintenance Dose: Administered at 25 mg/kg every 12 hours (twice daily) for 48 hours. Receives: Drug: Magnesium sulfate (MgSO4) |
| Group (B): Will receive intravenous normal saline as a placebo. | Experimental | 32 patients Will receive intravenous normal saline as a placebo. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured by the change in serum concentrations of the NLRP3 inflammasome complex
Molecular Anti-inflammatory Response: Measured by the change in serum concentrations of the NLRP3 inflammasome complex components from baseline (T₀) to 48 hours post-intervention (T₄₈), quantified via Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: Measured by the change in serum concentrations of the NLRP3 inflammasome complex components from baseline (T₀) to 48 hours post-intervention (T₄₈), quantified via Enzyme-Linked Immunosorbent Assay (ELISA)
Secondary outcomes (3)
Glasgow Coma Scale (GCS) score
Glasgow Coma Scale (GCS) score
Measured: day 7 post-injury and one month
Incidence of hypermagnesemia-related toxicity or drug-related adverse events
measurement of magnesium sulfate on admission and post intervention
Measured: 48 hours
ESR, CRP and serum Magnesium levels on admission (T₀) and 48 hours post-intervention (T₄₈)
ESR, CRP and serum Magnesium levels on admission (T₀) and 48 hours post-intervention (T₄₈)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab William Samir, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763665
- Sponsor's protocol ID
- effect of MgSO₄ in TBI
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Effect of Magnesium Sulfate on the Outcomes of Patients With Moderate Traumatic Brain Injury.
- ClinicalTrials.gov ID
- NCT07763665
- Acronym / sponsor ID
- effect of MgSO₄ in TBI
- Conditions
- Traumatic Brain Injuries
- Keywords
- anti-inflammatory effect of magnesium sulfate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI) at Assiut University Hospitals by measuring Nucleotide-binding oligomerization domain-Like Receptor Pyrin domain-containing 3 (NLRP3) inflammasome-a multiprotein complex.
Detailed description
Traumatic brain injury (TBI) remains a leading cause of mortality and long-term disability worldwide, disrupting both individual lives and healthcare systems. The pathophysiology of TBI is characterized by a biphasic process. The primary injury occurs at the moment of impact, resulting in immediate mechanical tissue disruption. This is followed by a complex cascade of cellular and molecular changes known as secondary brain injury, which develops hours to days later.
A cornerstone of this secondary injury pathway is neuroinflammation, driven by the activation of resident microglia and the infiltration of peripheral immune cells. Central to this inflammatory response is the assembly and activation of the Nucleotide-binding oligomerization domain-Like Receptor Pyrin domain-containing 3 (NLRP3) inflammasome-a multiprotein complex that triggers the maturation and release of potent pro-inflammatory cytokines, specifically interleukin-1β (IL-1β) and interleukin-18 (IL-18), accelerating neuronal apoptosis and blood-brain barrier dysfunction.
Magnesium sulfate (MgSO₄) has emerged as a promising neuroprotective candidate due to its multifaceted mechanism of action. Primarily, magnesium acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, thereby mitigating glutamate-mediated excitotoxicity. Emerging molecular evidence further indicates that magnesium exerts potent anti-inflammatory effects by downregulating nuclear factor kappa B (NF-κB) activation and directly inhibiting the assembly of the NLRP3 inflammasome. Consequently, evaluating the clinical and molecular efficacy of MgSO₄ in TBI patients could offer a viable therapeutic pathway to suppress secondary neuroinflammation and optimize neurological recovery.
NLRP3 Inflammasome is a multiprotein complex consisting of three core components:
- Sensor (NLRP3)
- Adaptor (ASC)
- Effector (Caspase-1)
Its activation is regulated by a two-signal framework:
- Priming (Signal 1): Activates the nuclear factor kappa B(NF-κB) pathway to produce baseline NLRP3 components and inactive proteins (Pro-IL-1β, P ro-IL-18 andPro-IL-6).
- Activation (Signal 2): Triggered by cellular stress signals (such as Ca 2+ influx, K efflux, and mitochondrial distress).
Active Caspase-1 processes cytokines into their potent active forms and triggers a inflammatory cell death.
Magnesium sulfate (MgSO₄) has emerged as a promising neuroprotective candidate.
Magnesium sulfate exerts potent anti-inflammatory effects that can inhibit NLRP3 Inflammasome activation through 4 mechanisms:
- downregulating nuclear factor kappa B (NF-κB) activation and directly inhibiting the assembly of the NLRP3 inflammasome
- preventing extracellular Ca2+ influx and intracellular release
- Reducing K Efflux
- Preserving Mitochondrial Integrity
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A): Will receive intravenous magnesium sulfate MgSO₄. | Experimental | Drug: Magnesium sulfate (MgSO4)32 patients will receive * Loading Dose: Administered within 8 hours of trauma at a dose of 50 mg/kg via IV infusion over 1 hour. * Maintenance Dose: Administered at 25 mg/kg every 12 hours (twice daily) for 48 hours. |
| Group (B): Will receive intravenous normal saline as a placebo. | Experimental | Drug: Normal Saline32 patients Will receive intravenous normal saline as a placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female patients aged 18 to 60 years.
- Sustained a closed head trauma with the study drug infusion initiated within 8 hours of the injury.
- TBI confirmed by history and clinical examination.
- Patients with moderate (GCS = 9-12) traumatic brain injury.
- Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification ).
Key exclusion criteria (14 listed)
- Patient Refusal
- Prolonged and/or uncorrectable hypoxia (PaO₂ < 60 mmHg) or persistent hypotension (systolic blood pressure < 90 mmHg) at the time of randomization.
- Cardiopulmonary arrest.
- Concomitant spinal cord injury.
- Pregnant or lactating females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfate (MgSO4)evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI) | Drug | Group (A): Will receive intravenous magnesium sulfate MgSO₄. |
| Normal Salineevaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI) | Drug | Group (B): Will receive intravenous normal saline as a placebo. |
Primary outcome
Measured by the change in serum concentrations of the NLRP3 inflammasome complex
Time frame: Measured by the change in serum concentrations of the NLRP3 inflammasome complex components from baseline (T₀) to 48 hours post-intervention (T₄₈), quantified via Enzyme-Linked Immunosorbent Assay (ELISA)
Molecular Anti-inflammatory Response: Measured by the change in serum concentrations of the NLRP3 inflammasome complex components from baseline (T₀) to 48 hours post-intervention (T₄₈), quantified via Enzyme-Linked Immunosorbent Assay (ELISA)
3 secondary outcomes
Glasgow Coma Scale (GCS) score
Time frame: day 7 post-injury and one month
Incidence of hypermagnesemia-related toxicity or drug-related adverse events
Time frame: 48 hours
ESR, CRP and serum Magnesium levels on admission (T₀) and 48 hours post-intervention (T₄₈)
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium sulfate (MgSO4) and Normal Saline in people with Traumatic Brain Injuries, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ehab Samir, Assistant lecturer (+201003078676, hobasamir12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured by the change in serum concentrations of the NLRP3 inflammasome complex (time frame: Measured by the change in serum concentrations of the NLRP3 inflammasome complex components from baseline (T₀) to 48 hours post-intervention (T₄₈), quantified via Enzyme-Linked Immunosorbent Assay (ELISA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.