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NCT05337618 · ClinicalTrials.gov registry record · Phase 2
Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)
A Phase 2 study of Traumatic Brain Injury, sponsored by University of Cincinnati.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT05337618: Recruiting Phase 2 study of Traumatic Brain Injury, sponsored by University of Cincinnati.
NCT05337618 is a Phase 2 study of Traumatic Brain Injury that is actively recruiting participants, run by University of Cincinnati. The registered enrollment target is 72 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05337618, a Phase 2 study of Traumatic Brain Injury, is actively recruiting participants, sponsored by University of Cincinnati.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a randomized Phase 2 trial to determine the feasibility of real-time electrocorticographic monitoring of spreading depolarizations (SD) to guide implementation of a tier-based protocol of intensive care therapies, aimed at SD suppression, for the management of patients who have undergone acute operative treatment of severe traumatic brain injury.
Primary Outcome
Spreading depolarization events will be scored based on review of electrocorticographic recordings. The number of depolarizations per recording day over the period of monitoring will serve as the measure of total burden. The burdens computed for patients will be compared between the two randomization arms.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Full-band Electrocorticography
- COMBINATION_PRODUCT Treatment Algorithm
Study Locations (1)
Ohio
- University of Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2022-12-16 |
| Est. Completion | 2027-03-20 |
| Phase | Phase 2 |
What NCT05337618 shows while recruiting
NCT05337618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Full-band Electrocorticography is the first listed.
NCT05337618 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05337618 about?
NCT05337618 is a clinical study titled "Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)". This study is a randomized Phase 2 trial to determine the feasibility of real-time electrocorticographic monitoring of spreading depolarizations (SD) to guide implementation of a tier-based protocol of intensive care therapies, aimed at SD suppression, for the management of patients who have undergo...
What is the current status of trial NCT05337618?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2022-12-16. Estimated completion is 2027-03-20.
What conditions does trial NCT05337618 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT05337618?
The interventions under investigation include: Full-band Electrocorticography (DIAGNOSTIC_TEST), Treatment Algorithm (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05337618?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05337618 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05337618's enrollment target sits among peer trials
72 94th of 171 higher than 77 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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