Understanding brain activity after severe traumatic brain injury
Official title: Cortical Spreading Depolarization After Severe Traumatic Brain Injury
Run by Hennepin Healthcare Research Institute · NCT03321370 · Data updated 2026-11-12
This study is trying to understand brain activity in patients with severe traumatic brain injuries to see how certain brain changes might affect recovery and help find better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Hennepin Healthcare Research Institute Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | August 14, 2019 |
| Main results expected | November 1, 2027 |
| Study ends | November 1, 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT03321370 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients recommended for craniectomy or craniotomy due to acute traumatic brain injury.
✕Probably not a fit
Patients with contaminated wounds, those undergoing decompression only in the posterior fossa, or those with known systemic infections or pregnancy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates brain activity using electrodes placed on the brain to record and analyze cortical spreading depolarizations (CSDs) following severe traumatic brain injury (TBI) that requires neurosurgical intervention. The aim is to enhance understanding of CSDs as a mechanism of secondary injury, which can worsen outcomes after TBI. By identifying the factors that influence CSD initiation and frequency, the study seeks to inform potential therapeutic strategies to mitigate secondary brain injury. The research is observational and focuses on patients undergoing craniectomy or craniotomy for acute TBI.
Why it matters
Potential benefit: If successful, this study could lead to improved therapeutic strategies that minimize secondary brain injury in patients with severe TBI.
How similar studies have gone: While this approach is novel in its specific focus on CSDs in TBI, previous studies have shown the importance of understanding secondary injury mechanisms in improving outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient recommended to undergo craniectomy or craniotomy for the treatment of acute TBI Exclusion Criteria: * Wound determined to be contaminated * Decompression is performed only in the posterior fossa * Known systemic infection * Pregnancy
Where it's running
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Hennepn Healthcare
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Samuel W Cramer, MD, PhD — University of Minnesota Neurosurgery Department; Division of Neurosurgery, Department of Surgery, Hennepin County Medical Center
- Study coordinator: Samuel W Cramer, MD, PhD
- Email: rnl@umn.edu
- Phone: 612-624-6666
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.