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Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)
Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT): a Phase 2 Randomized, Feasibility Trial
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Full-band Electrocorticography (diagnostic test)
- Treatment Algorithm (combination product)
Sponsor: University of Cincinnati · Participants: 72 · Started: Dec 16, 2022
Contact the study team
- Jed A Hartings, PhD · Phone: 513-295-2370
- Karmen Herzig · Phone: 513-558-0440
Official record on ClinicalTrials.gov — NCT05337618
Locations in the U.S.
| Ohio | University of Cincinnati, Cincinnati |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.