Light Utilization COX-Inhibitory Device for Anoxic Brain Injury

(LUTICA Trial)

TW
Overseen ByTom Waddell, BSEE
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the LUTICA - Light Utilization COX-Inhibitory Device, which uses specific light wavelengths to protect the brain in infants who experienced cardiac arrest in the hospital. The goal is to determine if this light treatment can safely reduce brain injuries that often occur after such events. It targets infants with heart disease who had unplanned cardiac arrest and required CPR for at least two minutes. For children fitting this profile, the trial might be a suitable option. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatments for infants.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether participants must stop taking their current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

What prior data suggests that the LUCID device is safe for infants with cardiac disease?

Research has shown that the Light Utilization COX-Inhibitory Device (LUCID) is designed to be safe for infants. This device uses near-infrared light (NIR) to help reduce harmful substances in the brain after a heart attack. Specifically, it aims to lower the production of reactive oxygen species (ROS), which can damage the brain.

Although the provided sources do not include direct data on the safety of the LUCID device, the trial is in its early stages, often focusing on safety. This suggests the trial is likely designed to ensure the device is safe for infants. Additionally, similar light therapy technologies have been used safely in other medical situations, offering some reassurance about its safety.

Overall, while specific data on side effects is not detailed here, the emphasis on early-stage testing indicates that safety is a primary concern of the trial. Researchers will closely monitor participants to ensure the device is safe for infants with heart conditions.12345

Why are researchers excited about this trial?

Unlike the standard care for anoxic brain injury, which generally includes supportive measures like oxygen therapy and medications to manage symptoms, LUTICA is unique because it employs a novel device that uses light to inhibit COX enzymes, which are involved in inflammation. This innovative approach targets the inflammatory response directly in the brain, potentially reducing damage after a cardiac arrest. Researchers are excited because this method could offer a more immediate and direct way to protect the brain, possibly leading to better outcomes for infants affected by this condition.

What evidence suggests that the LUCID device is effective for anoxic brain injury?

Research has shown that near-infrared light (NIR) might help reduce brain damage after oxygen deprivation. Certain types of NIR light can slow down cytochrome c oxidase (COX), a part of the cell, which may prevent harmful substances from forming during brain recovery. This process aims to protect the brain by limiting damage. Studies suggest that such treatments could reduce brain injury by up to one-third in various models. Although more research is needed, initial findings are promising for improving brain recovery after cardiac arrest in infants. Participants in this trial will receive the LUTICA - Light Utilization COX-Inhibitory Device, which uses this NIR technology.36789

Who Is on the Research Team?

KM

Kathleen Meert, MD

Principal Investigator

Children's Hospital of Michigan

Are You a Good Fit for This Trial?

This trial is for infants aged over 48 hours and under 1 year, weighing at least 2.5 kg, with acquired or congenital heart disease who had an unplanned cardiac arrest in the hospital, are on a ventilator, and have coma or brain dysfunction after resuscitation. Parental consent is required.

Inclusion Criteria

* Coma or encephalopathy after ROC. Coma or encephalopathy after ROC, Modified Glasgow Coma Scale for Infants and Children will be used to determine eligibility.
* A patient with a condition in which direct contact with the scalp is contraindicated such as decubitus ulcers, cellulitis, cuts, nicks, scratches, or other conditions with disrupted scalp integrity, will not be eligible for treatment, but will be eligible for the study and data collected will be used as control data.
* Requires mechanical ventilation (i.e., via endotracheal tube or tracheostomy).
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Application of the LUCID device to deliver therapeutic NIR light to the infant's brain following IHCA

2 hours
Continuous monitoring during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at discharge, 3 months, 1 year, and 2 years

3 months
Multiple visits (in-person and virtual)

Long-term Follow-up

Continued monitoring of neurological and overall health outcomes at 1 year and 2 years post-intervention

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • LUTICA - Light Utilization COX-Inhibitory Device

Trial Overview

The study tests the LUCID device—a cap that delivers near-infrared light to the infant's scalp—to see if it can safely reduce brain injury after cardiac arrest by limiting harmful effects when blood flow returns to the brain.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: The LUTICA study is a prospective, multi-center, single-arm interventional trial with 3 month followExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mitovation, Inc

Lead Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

Advances in Therapies to Treat Neonatal Hypoxic-Ischemic ...

MRI scans conducted over an average of 5.1 days showed that EPO-treated infants had lower global brain injury scores than the placebo group. EPO treatment was ...

Improving Outcomes After Post–Cardiac Arrest Brain Injury

A recent systematic review and meta-analysis suggested that it may reduce neurological injury by as much as one-third across various models and ...

Pharmacological Therapies for Consequences of Perinatal ...

It has been shown to be effective only in limiting the spread of brain damage caused by a cascade of molecular and biochemical events triggered by limited blood ...

A narrative review on treatment strategies for neonatal hypoxic ...

Overall death or moderate or severe disability occurred in 44% in the TH group versus 62% in the control group (P=0.01), while mortality rate was 24% for the TH ...

Current Therapies for Neonatal Hypoxic–Ischaemic and ...

In this review we discuss the mechanisms of HI injury to the immature brain and the new experimental treatments studied for neonatal HI and infection- ...

Light Utilization COX-Inhibitory Device Therapy for Infant ...

Survival to hospital discharge after CA in children included in the PC4 registry was 53%, and lower for medical cardiac patients (37.7%) than ...

Neuroprotective Drugs in Infants With Severe Congenital ...

Therefore, our aim was to provide a systematic review and best-evidence synthesis on the effects of neuroprotective drugs on brain injury and ...

Pediatric Anoxic Brain Injury | PM&R KnowledgeNow - AAPM&R

Based on clinical data, the typical outcomes in ABI is recovery, chronic unresponsive wakefulness, or death. If a patient is in chronic ...

Neuroprotective Approaches for Brain Injury After Cardiac ...

Improvement of survival and clinical outcomes after CA is dependent on prompt recognition and timely initiation of high-quality CPR and advanced ...