Transcranial Photobiomodulation for Cognitive Decline

Overseen By Alison Mancera, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Arlington

Disqualifiers: Brain injuries, Epilepsy, Pacemakers, others

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called transcranial photobiomodulation, which uses a special helmet to shine low-level laser light on the head. This method aims to potentially boost brain function and improve blood flow. Researchers seek to determine if it can help individuals experiencing cognitive decline, such as memory or thinking difficulties. Participants will either receive the light therapy or wear the helmet without the light for comparison. This trial may suit adults who have noticed ongoing issues with memory or thinking. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to new ways to support cognitive health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that transcranial photobiomodulation (tPBM) is generally safe for people. One study using a 1064 nm laser for tPBM found no harm to the brain or impact on thinking skills. Another study confirmed the therapy's safety and its noticeable effects on the brain.

tPBM is a non-invasive method, meaning it doesn't involve surgery or entering the body. It uses low-level laser therapy to enhance brain activity. Tested on both animals and humans, this method is considered safe and cost-effective for improving thinking abilities.

Overall, evidence suggests that tPBM is well-tolerated, with no major side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial photobiomodulation (tPBM) for cognitive decline because it offers a non-invasive way to potentially boost brain function. Unlike standard treatments that might involve medication or lifestyle changes, tPBM uses a helmet to deliver low-level laser therapy directly to the brain. This approach aims to enhance mitochondrial activity and improve cerebral blood flow, which could lead to better cognitive function. The novelty lies in its mechanism of activating the brain’s cellular pathways without drugs, which might offer a fresh avenue for treating cognitive decline.

What evidence suggests that transcranial photobiomodulation could be an effective treatment for cognitive decline?

Research has shown that transcranial photobiomodulation (tPBM), which participants in this trial may receive, can enhance brain function and thinking skills. This treatment uses low-level laser therapy to improve memory and decision-making abilities. It boosts blood flow in the brain and increases energy production in brain cells, both crucial for brain health. Studies with animals and some human trials have demonstrated improved thinking skills with this treatment. Importantly, researchers have found no negative effects on brain structure or function. Overall, the evidence suggests that tPBM is a promising method to support brain health and cognitive function. ^{1 3 4 5 6}

Who Is on the Research Team?

Robert M Brothers, PhD

Principal Investigator

University of Texas at Arlington

Are You a Good Fit for This Trial?

This trial is for individuals with vascular disease, cognitive decline, or Alzheimer's. It includes those with peripheral arterial or vascular disease who are interested in a non-invasive treatment aimed at improving brain health and cognition.

Exclusion Criteria

Abnormal results from the blood screening will not impact eligibility for the study.

I have not donated more than 550 ml of blood in the last 8 weeks.

Individuals with brain injuries/surgeries in a year before the study and individuals who cannot provide consent on their own will be excluded from participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial photobiomodulation (tPBM) therapy up to 8 times over a 4-week period

4 weeks

Up to 8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Photobiomodulation
• Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) with no light administered

Trial Overview The study tests the effects of a Transcranial Photobiomodulation helmet (Neuradiant 1070 Plus) on brain blood flow and mental function. Some participants will receive no light as a comparison group.

How Is the Trial Designed?

Group I: Transcranial Photobiomodulation Experimental Treatment 1 Intervention

Transcranial Photobiomodulation (tPBM) is a novel and non-invasive strategy that utilizes a helmet that delivers low-level laser therapy to activate intracellular enzymatic pathways leading to an increase in mitochondrial activity, cerebral oxygenation, and thus neural and overall brain function. Importantly, this approach improves cognitive function in various animal models and limited human populations. Furthermore, there is limited evidence to suggest that these neurocognitive improvements are in-part related to increases in cerebral blood flow and cerebral vascular function/health.

Group II: Sham condition Placebo Group 1 Intervention

In this condition the participants will wear the Transcranial Photobiomodulation (tPBM) headgear; however, no light will be delivered.

Transcranial Photobiomodulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Photobiomodulation for:

• Not approved for any indication; under investigation for Alzheimer's Disease and Mild Cognitive Impairment

Approved in European Union as Transcranial Photobiomodulation for:

• Not approved for any indication; under investigation for Alzheimer's Disease and Mild Cognitive Impairment

Who Is Running the Clinical Trial?

The University of Texas at Arlington

Lead Sponsor

Trials

48

Recruited

7,300+

Published Research Related to This Trial

In a pilot study involving healthy individuals over 45 years old, near-infrared transcranial photobiomodulation therapy (PBM-T) significantly improved motor function, memory performance, and processing speed compared to a placebo group.

The therapy was administered safely at home using a specialized helmet device, with no reported adverse effects, suggesting that PBM-T could be a promising method for enhancing cognitive abilities in middle-aged individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Transcranial Near-Infrared Light 1068 nm Upon Memory Performance in Aging Healthy Individuals: A Pilot Study. Dougal, G., Ennaceur, A., Chazot, PL.[2021]

Photobiomodulation (PBM) uses red or near-infrared light to potentially heal and protect brain tissue affected by various disorders, including traumatic injuries, degenerative diseases, and psychiatric conditions.

Recent advancements, such as affordable LED light-emitting helmets, have made it easier to apply PBM to the brain, showing promise for cognitive enhancement and treatment of brain disorders based on pre-clinical and clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shining light on the head: Photobiomodulation for brain disorders. Hamblin, MR.[2020]

This study is a double-blinded, randomized controlled trial involving 32 patients with diffuse axonal injury from severe traumatic brain injury, testing the effects of transcranial LED therapy on cognitive function and cerebral circulation.

The therapy involves 18 sessions of LED stimulation over 6 weeks, and aims to improve cognitive outcomes and promote beneficial changes in blood flow to the brain, addressing a gap in clinical trials for TBI cognitive rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial. Santos, JGRPD., Zaninotto, ALC., Zângaro, RA., et al.[2023]

Near-infrared laser therapy (NIRLT) is being studied as a potential treatment for acute ischemic stroke patients in a pivotal phase III trial (NEST-3), focusing on its neuroreparatory and neuroprotective effects.

The review discusses the theoretical background and experimental studies supporting NIRLT, indicating its promise in clinical applications for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Near-infrared laser treatment of acute stroke: from bench to bedside]. Schellinger, PD., Köhrmann, M.[2021]

Transcranial photobiomodulation (PBM) using NIR light has shown promising results in treating traumatic brain injury (TBI) in mice, leading to improved memory and learning, as well as increased neuroprogenitor cells and synaptogenesis in the brain.

The mechanism of action involves photon absorption in mitochondria, which activates signaling pathways that enhance protective gene expression, suggesting that PBM could have broader applications for various neurological conditions beyond TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation and the brain: a new paradigm. Hennessy, M., Hamblin, MR.[2020]

Photobiomodulation is a promising and safe treatment for psychological disorders, particularly effective for depression and cognitive enhancement, based on a systematic review of studies up to 2019.

The optimal treatment parameters include using wavelengths of 810 nm for depression and 1064 nm for cognitive enhancement, with specific irradiance and yield settings, applied weekly to the prefrontal area for sustained effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation as a promising new tool in the management of psychological disorders: A systematic review. Gutiérrez-Menéndez, A., Marcos-Nistal, M., Méndez, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5180077/

Transcranial Low-Level Laser (Light) Therapy for Brain Injury Low-level laser therapy (LLLT) has been investigated as an alternative treatment for stroke, and LLLT has been shown to have a neuroprotective effect,38,39 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X24001955

Transcranial low-level laser stimulation in the near-infrared ... Our data indicate that 1064 nm laser tPBM does not induce adverse effects on brain structure or function, nor does it impair cognitive abilities.

3. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-023-03988-w

Advances in photobiomodulation for cognitive improvement by ... In the field of cognition-related disorders, studies have shown that transcranial photobiomodulation improves executive performance, memory, ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2770551

Effect of Transcranial Low-Level Light Therapy vs Sham ... The results of this clinical trial show that transcranial LLLT is feasible, safe, and affects the brain in a measurable manner.

5. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2019.01129/full

Cognitive Enhancement by Transcranial ... A laser-fNIRS combination may be useful to stimulate and monitor cerebrovascular oxygenation associated with neurocognitive enhancement.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10840571/

Transcranial photobiomodulation for brain diseases: review of ... Transcranial photobiomodulation (tPBM) is a promising technology for treating brain diseases, due to its effectiveness, non-invasiveness, and affordability.