Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT05337618

Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)

Led by University of Cincinnati · Updated on 2025-12-22

72

Participants Needed

1

Research Sites

222 weeks

Total Duration

On this page

Sponsors

U

University of Cincinnati

Lead Sponsor

U

University of New Mexico

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical indication for emergency craniotomy with dural opening to treat acute traumatic brain injury within 72 hours after trauma
  • Age between 18 and 80 years
Not Eligible

You will not qualify if you...

  • Persistent bilateral non-reactive pupils or other evidence of non-survivable injury
  • Decompressive craniectomy to treat refractory intracranial pressure after diffuse injury
  • Co-enrollment in another therapeutic traumatic brain injury trial
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Cincinnati

Cincinnati, Ohio, United States, 45267

Actively Recruiting

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Research Team

J

Jed A Hartings, PhD

CONTACT

K

Karmen Herzig

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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