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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-injury

Awards & highlights

INDICT Trial 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.

INDICT Trial 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

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

INDICT 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor

428 Previous Clinical Trials

634,322 Total Patients Enrolled

University of New MexicoOTHER

372 Previous Clinical Trials

3,528,717 Total Patients Enrolled

University of PennsylvaniaOTHER

2,005 Previous Clinical Trials

42,882,137 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Full-band Electrocorticography for clinical use?

"Our experts at Power judged that Full-band Electrocorticography has a relative safety score of 2. This is because while there are studies showing its security, none have proven efficacy yet."

Answered by AI

Is recruitment for this experiment still in progress?

"According to clinicaltrials.gov, this medical trial is closed for recruitment at the moment; it was initially advertised on September 1st 2022 and last updated on July 7th 2022. Although participant intake has ended, 311 other research projects have open positions available right now."

Answered by AI

Does this research endeavor allow persons below the age of 35 to participate?

"According to the criteria, only individuals between 18 and 80 years of age can qualify. Moreover, there are 61 studies designed for minors while 225 trials have been tailored to serve seniors."

Answered by AI

Am I eligible to participate in this clinical examination?

"To qualify for the clinical trial, individuals must have been diagnosed with traumatic brain injury (TBI) and be aged 18 to 80. The researchers aim to enrol a cohort of 72 patients in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)

Jed Hartings 2022. "Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05337618.