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RECRUITING
NCT05337618
PHASE2

Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)

Sponsor: University of Cincinnati

View on ClinicalTrials.gov

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.

Official title: Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT): a Phase 2 Randomized, Feasibility Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2022-12-16

Completion Date

2027-03-20

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Full-band Electrocorticography

Diagnosis of spreading depolarizations in continuous electrocorticography

COMBINATION_PRODUCT

Treatment Algorithm

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

Locations (1)

University of Cincinnati

Cincinnati, Ohio, United States