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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-injury

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Burden of spreading depolarizations

Secondary study objectives

Brain Hypoxia

Burden of elevated intracranial pressure

Cerebral Perfusion Pressure

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met