Using real-time brain monitoring to improve treatment for severe traumatic brain injury
Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT): a Phase 2 Randomized, Feasibility Trial
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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05337618 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients requiring emergency craniotomy for acute traumatic brain injury within 72 hours of trauma.
Not a fit: Patients with non-survivable injuries or those undergoing decompressive craniectomy for refractory intracranial pressure will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cincinnati, Ohio
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Jed A Hartings, PhD
- Email: jed.hartings@uc.edu
- Phone: 513-295-2370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.