Light Utilization COX-Inhibitory Device for Anoxic Brain Injury
(LUTICA Trial)
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.12345Why 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Application of the LUCID device to deliver therapeutic NIR light to the infant's brain following IHCA
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments at discharge, 3 months, 1 year, and 2 years
Long-term Follow-up
Continued monitoring of neurological and overall health outcomes at 1 year and 2 years post-intervention
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?
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Treatment groups
Experimental Treatment
The study population is infants greater than 48 hours and less than 1 year of age, with acquired or congenital heart disease, who experience IHCA (In Hospital Cardiac Arrest) for two minutes or longer with ROC (Return of Circulation). Because the LUCID device needs to be applied to the infant's head as close to the time of ROC as possible and within 2 hours of ROC, parents/guardians will need to have provided their consent for study participation prior to the infant's IHCA event. Infants will be screened and parents/guardians approached for consent (1) at the infant's pre-operative clinic visit with the cardiovascular surgeon or cardiologist, or (2) after admission to the hospital but prior to the cardiac arrest event.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mitovation, Inc
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
National Institutes of Health (NIH)
Collaborator
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 ...
5.
frontiersin.org
frontiersin.org/journals/synaptic-neuroscience/articles/10.3389/fnsyn.2021.709301/fullCurrent 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- ...
6.
ctv.veeva.com
ctv.veeva.com/study/light-utilization-cox-inhibitory-device-therapy-for-infant-cardiac-arrest-lutica-study-the-lucidLight 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 ...
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