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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall research objective of this proposal is to determine the acute and chronic impact of transcranial photobiomodulation on indices of cerebral vascular health and neurocognitive function.

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.

What data supports the effectiveness of the treatment Transcranial Photobiomodulation for Cognitive Decline?

Research shows that transcranial photobiomodulation (using red or near-infrared light) can improve memory, motor function, and processing speed in healthy middle-aged individuals. It has also shown promising results in treating brain disorders like traumatic brain injury, stroke, and Alzheimer's disease, suggesting potential benefits for cognitive decline. ^{1 2 3 4 5}

Is transcranial photobiomodulation generally safe for humans?

Research on transcranial photobiomodulation (PBM), also known as low-level light therapy, shows it is generally safe for humans. Studies, including those on healthy individuals and various brain disorders, report no adverse effects, suggesting it is a promising and safe approach for brain health. ^{1 2 3 4 5}

How does the treatment Transcranial Photobiomodulation differ from other treatments for cognitive decline?

Transcranial Photobiomodulation is unique because it uses red or near-infrared light to stimulate and protect brain cells, potentially improving memory and cognitive function. Unlike traditional treatments, it involves wearing a helmet that emits light, which is non-invasive and has shown promise in enhancing brain function without adverse effects. ^{1 2 3 4 6}

Research Team

Robert M Brothers, PhD

Principal Investigator

University of Texas at Arlington

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 80 years old.

Exclusion Criteria

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Photobiomodulation and the brain: a new paradigm. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

[Near-infrared laser treatment of acute stroke: from bench to bedside]. [2021]

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

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

5. England 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. [2023]

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

Photobiomodulation as a promising new tool in the management of psychological disorders: A systematic review. [2021]