Recruiting

Observational Study

Sponsor:

Hennepin County Medical Center, Minneapolis

Code:

NCT03321370

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous electrocorticography post severe traumatic brain injury requiring neurosurgical intervention

Study Details

Brief summary:

Preliminary evaluation of electrodes placed on the brain for recording brain activity and novel algorithms to determine cortical spreading depolarization foci of origination following severe traumatic brain injury requiring neurosurgical intervention.

Conditions

Traumatic Brain Injury

Study ID

NCT03321370

Start date

Aug 14, 2019

Status verified date

Mar, 2025

Completion date

Nov 1, 2025

Anticipated

Primary completion date

Nov 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Interventions

Continuous electrocorticography post severe traumatic brain injury requiring neurosurgical intervention

Continuous electrocorticography via subdural electrode strips for 1 to 3 weeks in the neuro intensive care unit following traumatic brain injury

Primary outcome measure

  • Determination of foci that give rise to cortical spreading depolarizations [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Samuel W Cramer, MD, PhD

612-624-6666rnl@umn.edu

David P Darrow, MD, MPH

612-624-6666rnl@umn.edu

Locations

Hennepn Healthcare

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Samuel W Cramer, MD, PhD

612-873-9113rnl@umn.edu

David Darrow, MD, MPH

612-624-6666

More Information

Sponsor

Hennepin County Medical Center, Minneapolis

Last update posted

Sep 12, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hennepin County Medical Center, Minneapolis on 2025-09-12.