Recruiting
Phase 2

Depolarization Inhibition

Sponsor:

University of Cincinnati

Code:

NCT05337618

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Full-band Electrocorticography

Treatment Algorithm

Study Details

Brief summary:

This study is a randomized Phase 2 trial to determine the feasibility of real-time electrocorticographic monitoring of spreading depolarizations (SD) to guide implementation of a tier-based protocol of intensive care therapies, aimed at SD suppression, for the management of patients who have undergone acute operative treatment of severe traumatic brain injury.

Conditions

Traumatic Brain Injury

Study ID

NCT05337618

Start date

Dec 16, 2022

Status verified date

Dec, 2025

Completion date

Mar 20, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

(1) clinical indication for emergency craniotomy with dural opening to treat acute TBI within 72 hr post-trauma

Exclusion Criteria:

1. persistent bilateral non-reactive pupils or other evidence of non-survivable injury,
2. decompressive craniectomy to treat refractory ICP subsequent to diffuse injury, (3) co-enrollment in another therapeutic TBI trial, and

(4) pregnancy

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SD-Guided Care

In this arm, ECoG data will be reviewed for SDs in real-time using the bedside clinical CNS monitor. As a secondary measure, recognition of SDs will be facilitated by custom software on a laptop that receives data from the CNS monitor. Data on SD occurrence will be used to guide treatment in a tier-based therapeutic escalation and de-escalation protocol with the goal of SD suppression. Therapies to be used among the tiers include adjusted targets for MAP, CPP, PaCO2, plasma glucose, temperature, as well as ketamine pharmacotherapy. Changes between tiers are determined by the success or failure of SD suppression at the given treatment level.

no intervention: Standard ICU Care

Management in the Standard ICU Care arm will follow published national guidelines consisting of common ICU-based targets for physiologic intervention that are thought to mitigate the development of secondary brain injuries.

Continuous ECoG monitoring will be performed for seizure monitoring, but information on the course of SDs in these patients will not be used to guide care. To enforce blinding to SD-related ECoG data, the ECoG bedside software will be locked with password protection to prevent displays with frequency filtering and time/amplitude scales that are necessary to identify SDs.

Interventions

Full-band Electrocorticography

Diagnosis of spreading depolarizations in continuous electrocorticography

Treatment Algorithm

Protocol for escalation and de-escalation of physiologic-targeted and pharmacologic therapies to treat and prevent spreading depolarizations

Primary outcome measure

  • Burden of spreading depolarizations [ Time Frame: During the period of intensive care invasive monitoring, up to two weeks after injury ]

Central Contacts and Locations

Central contacts

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

More Information

Sponsor

University of Cincinnati

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2025-12-22.