Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment10 (estimated)
SponsorHennepin Healthcare Research Institute
Academic / other
Locations1 site (Minneapolis, Minnesota)
StatusRecruiting
StartedAugust 14, 2019
Main results expectedNovember 1, 2027
Study endsNovember 1, 2027
Registry record updatedOctober 29, 2026
Trial IDNCT03321370 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

  • 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

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.