Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)

Recruiting now · Phase 2

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT05337618

Run by

University of Cincinnati

People needed

72

Starts

2022-12-16

Expected to finish

2027-03-20

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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