← Back to Search

Combination Therapy

Brain Wave Monitoring for Traumatic Brain Injury (INDICT Trial)

Phase 2
Recruiting
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Decompressive craniectomy to treat refractory ICP subsequent to diffuse injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-injury
Awards & highlights

Summary

This trial will test whether using a brain wave monitor can help guide treatment for people who have had severe brain injuries from trauma.

Who is the study for?
This trial is for individuals who need emergency surgery (craniotomy) to treat severe traumatic brain injury within 72 hours after the injury. It's not for those with non-survivable injuries, those who've had a certain type of skull surgery due to swelling, are in another TBI study, or are pregnant.Check my eligibility
What is being tested?
The INDICT study tests if monitoring brain activity with electrocorticography can help guide intensive care treatments aimed at stopping spreading depolarizations—a harmful pattern seen after brain injuries—in patients post-surgery.See study design
What are the potential side effects?
Since this trial focuses on treatment algorithms and monitoring techniques rather than new medications, side effects may be related to the standard intensive care therapies used and the monitoring process itself.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I had surgery to relieve pressure inside my skull due to a severe brain injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-injury
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-injury for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Burden of spreading depolarizations
Secondary outcome measures
Brain Hypoxia
Burden of elevated intracranial pressure
Cerebral Perfusion Pressure
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SD-Guided CareExperimental Treatment2 Interventions
In this arm, ECoG data will be reviewed for SDs in real-time using the bedside clinical CNS monitor. As a secondary measure, recognition of SDs will be facilitated by custom software on a laptop that receives data from the CNS monitor. Data on SD occurrence will be used to guide treatment in a tier-based therapeutic escalation and de-escalation protocol with the goal of SD suppression. Therapies to be used among the tiers include adjusted targets for MAP, CPP, PaCO2, plasma glucose, temperature, as well as ketamine pharmacotherapy. Changes between tiers are determined by the success or failure of SD suppression at the given treatment level.
Group II: Standard ICU CareActive Control1 Intervention
Management in the Standard ICU Care arm will follow published national guidelines consisting of common ICU-based targets for physiologic intervention that are thought to mitigate the development of secondary brain injuries. Continuous ECoG monitoring will be performed for seizure monitoring, but information on the course of SDs in these patients will not be used to guide care. To enforce blinding to SD-related ECoG data, the ECoG bedside software will be locked with password protection to prevent displays with frequency filtering and time/amplitude scales that are necessary to identify SDs.

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
431 Previous Clinical Trials
634,474 Total Patients Enrolled
University of New MexicoOTHER
376 Previous Clinical Trials
3,528,585 Total Patients Enrolled
University of PennsylvaniaOTHER
2,027 Previous Clinical Trials
42,885,639 Total Patients Enrolled

Media Library

Treatment Algorithm (Combination Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05337618 — Phase 2
Traumatic Brain Injury Research Study Groups: SD-Guided Care, Standard ICU Care
Traumatic Brain Injury Clinical Trial 2023: Treatment Algorithm Highlights & Side Effects. Trial Name: NCT05337618 — Phase 2
Treatment Algorithm (Combination Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05337618 — Phase 2
~37 spots leftby Apr 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top