Understanding brain activity after severe traumatic brain injury
Cortical Spreading Depolarization After Severe Traumatic Brain Injury
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 |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hennepin County Medical Center, Minneapolis Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT03321370 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients recommended for craniectomy or craniotomy due to acute traumatic brain injury.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Minneapolis, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.