Light Therapy for Intraventricular Hemorrhage
(EFIL Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
OF
Overseen byOnajovwe Fofah, Medical
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rutgers, The State University of New Jersey
Disqualifiers: Older than 1 month, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The primary purpose of this study is to serve as a pilot study of the EFIL device treatment feasibility of IVH grades 3,4 to guide development of a larger trial. Primary outcomes will assess the following: safety of intervention, recruitment and consent process, acceptability of intervention by parents, retention rates, selection of most appropriate outcome measures, provide sample size estimates for a larger trial, increase the researchers\' experience with the study intervention. A complete list of objectives and aims are listed under "Objectives". This study hopes to treat 12-24 neonates using 650nm light of irradiance 10mW/cm2 for 5 minutes twice a day each day for 12 days. We will also call the parents at 6 months and 12 months to track developmental milestones.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
Is light therapy generally safe for humans?
How does low-level laser therapy differ from other treatments for intraventricular hemorrhage?
Low-level laser therapy (LLLT) is unique because it uses light to stimulate biological processes, potentially improving blood flow and tissue repair, unlike traditional treatments that may rely on medication or surgery. This non-invasive approach has shown benefits in other conditions like stroke and heart issues, suggesting it might offer a novel way to support recovery in intraventricular hemorrhage.23678
Research Team
OF
Onajovwe Fofah, Medical
Principal Investigator
Rutgers, The State University of New Jersey
Eligibility Criteria
This trial is for newborns with severe brain bleeding, known as Intraventricular Hemorrhage (IVH) grades 3 and 4. It aims to include about 12-24 infants who will receive a new light therapy treatment. Parents must consent to the study and agree to follow-up calls at 6 and 12 months for developmental tracking.Inclusion Criteria
My newborn has a severe brain bleed and is under 1 month old.
Exclusion Criteria
My baby does not have severe brain bleeding and is older than 1 month.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
Treatment
Participants receive 650nm light therapy with irradiance of 10mW/cm2 for 5 minutes twice a day for 12 days
12 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including head circumference and neurodevelopmental outcomes
4 months
Weekly head ultrasounds, phone surveys at 6 and 12 months
Treatment Details
Interventions
- Low Level Laser Therapy (Light Therapy)
Trial OverviewThe trial tests a Low Level Laser Therapy device called EFIL, which uses a specific red light on the babies' heads. The goal is to see if it's safe and feasible as a treatment option. Each baby gets this non-invasive treatment twice daily for twelve days.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Non-blinded, open label experimental armExperimental Treatment1 Intervention
The experimental arm will be administered treated with the study device. It will be 10 mW/cm\^2 of 650nm laser through use of a novel laser device given for 5 minutes twice daily for 12 days.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Newark Beth Israel Medical CenterNewark, NJ
Rutgers - New Jersey Medical School / University HospitalNewark, NJ
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Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
Trials
471
Patients Recruited
81,700+
References
Photostimulation of brain lymphatics in male newborn and adult rodents for therapy of intraventricular hemorrhage. [2023]Intraventricular hemorrhage is one of the most fatal forms of brain injury that is a common complication of premature infants. However, the therapy of this type of hemorrhage is limited, and new strategies are needed to reduce hematoma expansion. Here we show that the meningeal lymphatics is a pathway to remove red blood cells from the brain's ventricular system of male human, adult and newborn rodents and is a target for non-invasive transcranial near infrared photobiomodulation. Our results uncover the clinical significance of phototherapy of intraventricular hemorrhage in 4-day old male rat pups that have the brain similar to a preterm human brain. The course of phototherapy in newborn rats provides fast recovery after intraventricular hemorrhage due to photo-improvements of lymphatic drainage and clearing functions. These findings shed light on the mechanisms of phototherapy of intraventricular hemorrhage that can be a clinically relevant technology for treatment of neonatal intracerebral bleedings.
Low-level laser therapy applied transcranially to rats after induction of stroke significantly reduces long-term neurological deficits. [2022]Low-level laser therapy (LLLT) modulates various biological processes. In the present study, we assessed the hypothesis that LLLT after induction of stroke may have a beneficial effect on ischemic brain tissue.
Transcranial application of low-energy laser irradiation improves neurological deficits in rats following acute stroke. [2015]Low-level laser therapy (LLLT) has been shown to have beneficial effects on ischemic skeletal and heart muscles tissues. The aim of the present study was to approve the effectiveness of LLLT treatment at different locations on the brain in acute stroked rats.
The nuts and bolts of low-level laser (light) therapy. [2022]Soon after the discovery of lasers in the 1960s it was realized that laser therapy had the potential to improve wound healing and reduce pain, inflammation and swelling. In recent years the field sometimes known as photobiomodulation has broadened to include light-emitting diodes and other light sources, and the range of wavelengths used now includes many in the red and near infrared. The term "low level laser therapy" or LLLT has become widely recognized and implies the existence of the biphasic dose response or the Arndt-Schulz curve. This review will cover the mechanisms of action of LLLT at a cellular and at a tissular level and will summarize the various light sources and principles of dosimetry that are employed in clinical practice. The range of diseases, injuries, and conditions that can be benefited by LLLT will be summarized with an emphasis on those that have reported randomized controlled clinical trials. Serious life-threatening diseases such as stroke, heart attack, spinal cord injury, and traumatic brain injury may soon be amenable to LLLT therapy.
Low-level laser therapy for protection against skeletal muscle damage after ischemia-reperfusion injury in rat hindlimbs. [2015]Despite numerous hypotheses regarding the action of laser light, the use of low-level laser therapy (LLLT) in ischemic reperfusion (I/R) injury is still being verified. The present study investigates the effects of low-level laser irradiation (LLLI) on I/R injury of the musculus gracilis in rats.
[The intracardiac laser irradiation of the blood in correcting left ventricular dysfunction in progressive stenocardia]. [2016]The authors studied the effect of intracardiac irradiation of blood with a low intensity Helium-Neon laser on the pumping function of left ventricle in 73 patients with progressive angina pectoris. 47 patients underwent a course of laser hemotherapy while being given medicamentous therapy, the remaining 26 received nitrates, calcium antagonists and analgesics. Employment of laser light irradiation was associated with more satisfactory clinical effect than that in patients who had not had the procedure. It has also been established that intracardiac laser light irradiation of blood makes for the improvement of the characteristics of the intracardiac haemodynamics by diminishing the volumes and augmenting the left ventricular (LV) ejection fraction. Beneficial effect of laser hemotherapy on the intracardiac haemodynamics characteristics results from the stabilizing influence the method exerts on LV regional contractility and appear to be associated with its anti-ischemic effect.
[Changes in the oxygen balance of the body in the acute period of hemorrhagic shock and after resuscitation under the effect of intravascular helium-neon laser irradiation of the blood]. [2013]The effect of intravascular laser irradiation of the blood (ILIB) on the oxygen budget of the body and blood acid-base balance in the acute period of hemorrhagic shock and after resuscitation was studied in experiments on dogs. Duration of hypotension was 2 h. Laser therapy was started from the 5th-8th min of hypotension and lasted for 45 min; it was performed with a He-Ne laser (ALOK-1, 1 mWt power at the tip of the light guide, wavelength 633 nm) introduced in the right jugular vein. Exposure to ILIB in the acute period of hemorrhagic shock was conducive to creation of favorable conditions for realization of the compensatory mechanisms aimed at improvement of circulation and gas exchange in the lungs, at provision of delivery of oxygen to tissues and its utilization, and, hence, promoted the survival of animals by triggering the regulatory mechanisms of redistribution of the regional bloodflow, improvement of tissue perfusion, and possibly, of oxyhemoglobin dissociation processes in red cells.
Intravascular laser irradiation of blood as novel migraine treatment: an observational study. [2023]Migraine is one of four major chronic diseases that cause disability. Decreases in regional cerebral blood flow (rCBF) occur during migraine attacks. Laser therapy is extensively employed in treating other vascular diseases; nevertheless, its effectiveness in migraine management remains largely unknown. Therefore, we evaluated the effect of low-level intravascular laser irradiation of blood (ILIB) therapy in patients with migraine.