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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 80

Using real-time brain monitoring to improve treatment for severe traumatic brain injury

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

Run by University of Cincinnati · NCT05337618 · Data updated 2026-11-12

This study is testing if real-time brain monitoring can help doctors provide better care for patients recovering from severe traumatic brain injuries by identifying specific brain issues that need targeted treatment.

More Traumatic Brain Injury trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment72 (estimated)
SponsorUniversity of Cincinnati
Academic / other
Locations1 site (Cincinnati, Ohio)
StatusRecruiting
StartedDecember 16, 2022
Main results expectedSeptember 1, 2026
Study endsMarch 20, 2027
Registry record updatedDecember 22, 2025
Trial IDNCT05337618 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients requiring emergency craniotomy for acute traumatic brain injury within 72 hours of trauma.

Probably not a fit

Patients with non-survivable injuries or those undergoing decompressive craniectomy for refractory intracranial pressure will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial aims to assess the feasibility of using real-time electrocorticographic monitoring to identify spreading depolarizations (SD) in patients who have undergone surgery for severe traumatic brain injury (TBI). By monitoring SD, which is linked to worse neurological outcomes, the study seeks to implement a tier-based protocol of intensive care therapies specifically targeting patients who may benefit from SD suppression. The goal is to improve patient outcomes by tailoring intensive care management based on individual pathophysiological mechanisms. This innovative approach could lead to more effective treatment strategies for TBI patients.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients with severe traumatic brain injury.

How similar studies have gone: While the approach of monitoring spreading depolarizations is well-researched in animal models, this specific application in human TBI management is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • University of Cincinnati
    Cincinnati, Ohio, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.