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Improving Neurotrauma by Depolarization Inhibition With Combination Therapy: A Phase 2 Randomized Feasibility Trial
Jed A Hartings1, Jens P Dreier2,3,4,5,6, Laura B Ngwenya1
1Department of Neurosurgery, University of Cincinnati, Cincinnati , Ohio , USA.
Neurosurgery
|April 21, 2023
Summary
This study investigates using electrocorticography to monitor spreading depolarizations (SDs) in severe traumatic brain injury (TBI) patients. The goal is to personalize intensive care and reduce secondary brain injury by guiding treatment based on real-time SD activity.
Area of Science:
- Neuroscience
- Critical Care Medicine
- Neurological Surgery
Background:
- Spreading depolarizations (SDs) are a key mechanism in cerebral gray matter lesion development.
- SDs occur in approximately 60% of severe traumatic brain injury (TBI) patients, often progressively, and correlate with poor outcomes.
- Current clinical management lacks protocols for SD monitoring in TBI.
Purpose of the Study:
- To determine the feasibility and efficacy of an intensive care treatment protocol for severe TBI guided by electrocorticographic monitoring of SDs.
- To establish real-time diagnostic capabilities for SDs in intensive care settings.
- To reduce secondary injury in TBI patients through tailored management strategies.
Main Methods:
- Patients with severe TBI undergoing surgery with subdural electrode placement are eligible.
- Participants exhibiting SDs will be randomized to standard care or a tiered intervention protocol.
- Interventions include adjusted management of blood pressure, CO2, temperature, glucose, and ketamine, guided by SD activity.
Main Results:
- The study expects to show that SD monitoring enables meaningful changes in patient management.
- It anticipates a reduction in secondary injury compared to standard care.
- No increase in medical complications or adverse events is expected.
Conclusions:
- Electrocorticographic monitoring of SDs can serve as a real-time diagnostic tool in intensive care for TBI.
- This approach allows for personalized management, tailoring therapies to the specific neuronal mechanism of SD.
- Results are expected to validate this treatment concept and inform larger trials.
