Depth Electrode Detection of Cortical Spreading Depolarization After Traumatic Brain Injury

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05205174
Status
Recruiting
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Conditions

  • TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • depth electrodes — DEVICE
    The study will be conducted at a single center, in TBI patients requiring neurosurgical intervention in the form of EVD placement. During neurosurgical intervention at the bedside in the Intensive Care Unit (ICU), a single depth electrode will be placed in the brain adjacent to the EVD catheter in the same burr hole. After EVD and depth electrode placement, continuous recording of ECoG activity as well as relevant physiological parameters will be performed for the duration of clinically indicated invasive neuromonitoring in accordance with the standard of care for TBI patients. A single recording station is currently available for data collection, therefore, with an anticipated average recording period of 14 days, the study will take greater than 210 days to complete for a total of 15 patients.

Study Details

Preliminary evaluation of depth electrode recording and novel algorithms to determine Cortical Spreading Depolarization's (CSD) following traumatic brain injury (TBI) requiring neurosurgical intervention.

Key Dates

Start date
Apr 3, 2025
Status verified
Feb 2026
Primary completion
Dec 3, 2028
Completion
Dec 3, 2030

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Feasibility
    This is a preliminary, prospective interventional study to investigate the feasibility of using depth electrodes in conjunction with novel analytical algorithms to detect CSDs in TBI patients.

Primary Outcome Measure

Detecting CSDs in TBI patients [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hennepin County Medical CenterMinneapolisMinnesota55415
David Darrow, MD MPH
[email protected]
612-624-6666
Study Coordinator
[email protected]
612-873-9113
David Darrow, MD MPH (SUB_INVESTIGATOR)
Samual Cramer, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Hennepin County Medical Center· Minneapolis, MN

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