Light Therapy for Intraventricular Hemorrhage

(EFIL Trial)

Recruiting at 1 trial location

Overseen By Garrett Gianneschi, Medical

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Older than 1 month, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 days

24 Participants Needed

Trial Summary

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?

Low-level laser therapy (LLLT), also known as photobiomodulation, has been studied for various conditions and is generally considered safe. It has been used to improve wound healing and reduce pain, inflammation, and swelling, with no major safety concerns reported in the studies reviewed. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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\&#39; 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.

Research Team

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.

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

Trial Overview The 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

Group I: Non-blinded, open label experimental arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Findings from Research

Meningeal lymphatics play a crucial role in removing red blood cells from the brain's ventricular system, which is significant for treating intraventricular hemorrhage, especially in premature infants.

Transcranial near infrared photobiomodulation therapy in 4-day old rat pups showed promising results, enhancing lymphatic drainage and leading to faster recovery from intraventricular hemorrhage, suggesting a potential new treatment strategy for neonatal brain injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photostimulation of brain lymphatics in male newborn and adult rodents for therapy of intraventricular hemorrhage. Li, D., Liu, S., Yu, T., et al.[2023]

Low-level laser therapy (LLLT) applied 24 hours after stroke in rats significantly reduced neurological deficits, suggesting it may improve recovery in ischemic brain tissue.

The mechanism behind this benefit may involve the induction of neurogenesis, as evidenced by an increase in newly formed neuronal cells in the brain after LLLT treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy applied transcranially to rats after induction of stroke significantly reduces long-term neurological deficits. Oron, A., Oron, U., Chen, J., et al.[2022]

Low-level laser therapy (LLLT) significantly improved neurological function in acute stroked rats, as observed in three laser-treated groups compared to a control group over 28 days.

The study involved 169 rats and demonstrated that LLLT applied at various locations on the brain can effectively enhance recovery from stroke-related deficits, suggesting its potential as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial application of low-energy laser irradiation improves neurological deficits in rats following acute stroke. Detaboada, L., Ilic, S., Leichliter-Martha, S., et al.[2015]

Low Level Laser Therapy (LLLT) has shown potential in improving wound healing and reducing pain, inflammation, and swelling, with mechanisms of action observed at both cellular and tissue levels.

LLLT may soon be applicable to serious conditions like stroke and traumatic brain injury, as the field expands to include various light sources and wavelengths, supported by randomized controlled clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nuts and bolts of low-level laser (light) therapy. Chung, H., Dai, T., Sharma, SK., et al.[2022]

Low-level laser therapy (LLLT) significantly reduces markers of muscle damage, such as lactate dehydrogenase (LD) and creatine kinase (CK), in rats with ischemic reperfusion injury, indicating its efficacy in protecting muscle tissue.

LLLT also promotes healing by decreasing muscle necrosis and atrophy while enhancing neovascularization, suggesting it could be a beneficial treatment for muscle injuries caused by ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy for protection against skeletal muscle damage after ischemia-reperfusion injury in rat hindlimbs. Lakyová, L., Toporcer, T., Tomečková, V., et al.[2015]

In a study of 73 patients with progressive angina pectoris, intracardiac irradiation of blood using a low-intensity Helium-Neon laser improved left ventricular pumping function compared to standard medication alone.

The laser treatment led to better intracardiac hemodynamics, including reduced blood volumes and increased left ventricular ejection fraction, likely due to its stabilizing effect on heart muscle contractility and its anti-ischemic properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The intracardiac laser irradiation of the blood in correcting left ventricular dysfunction in progressive stenocardia]. Sychev, OS., Tashchuk, VK., Luk'ianova, IS., et al.[2016]

Intravascular laser irradiation of the blood (ILIB) applied during the acute phase of hemorrhagic shock in dogs improved circulation and gas exchange, enhancing oxygen delivery to tissues and promoting survival.

The laser therapy, initiated shortly after the onset of hypotension, activated compensatory mechanisms that improved blood flow and tissue perfusion, suggesting a potential therapeutic role for ILIB in managing hemorrhagic shock.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]. Kirsanova, AK., Novoderzhkina, IS., Kozhura, VL., et al.[2013]

In a study of 24 migraine patients, those receiving low-level intravascular laser irradiation of blood (ILIB) showed significant improvements in pain, cognitive function, and insomnia symptoms compared to a traditional rehabilitation group.

SPECT imaging revealed a notable increase in regional cerebral blood flow (rCBF) in the ILIB group, suggesting that this therapy may enhance vascular function and could be a promising treatment option for managing migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravascular laser irradiation of blood as novel migraine treatment: an observational study. Chen, HH., Lin, CY., Chen, SJ., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Photostimulation of brain lymphatics in male newborn and adult rodents for therapy of intraventricular hemorrhage. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Low-level laser therapy applied transcranially to rats after induction of stroke significantly reduces long-term neurological deficits. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Transcranial application of low-energy laser irradiation improves neurological deficits in rats following acute stroke. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

The nuts and bolts of low-level laser (light) therapy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Low-level laser therapy for protection against skeletal muscle damage after ischemia-reperfusion injury in rat hindlimbs. [2015]

6. Ukraine pubmed.ncbi.nlm.nih.gov

[The intracardiac laser irradiation of the blood in correcting left ventricular dysfunction in progressive stenocardia]. [2016]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[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]

8. England pubmed.ncbi.nlm.nih.gov

Intravascular laser irradiation of blood as novel migraine treatment: an observational study. [2023]