Photobiomodulation for Memory Loss

PI
Overseen ByPrincipal Investigator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether photobiomodulation (PBM) can assist individuals who feel their memory is declining, despite no medical diagnosis. PBM involves using special lights worn on the head, inserted in the nose, or placed on the neck to potentially improve mood and memory. The study will test three methods of using the lights and a sham version for comparison. Individuals concerned about memory decline, without a clinical diagnosis of dementia or other serious mental health conditions, may be suitable for this trial. Participants will use the device at home twice daily for five weeks. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for memory concerns.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently using anti-coagulants or have had certain treatments like electroconvulsive therapy or ketamine recently.

What prior data suggests that this photobiomodulation device is safe for use in individuals with subjective cognitive impairment?

Previous studies have shown that light therapy, known as photobiomodulation (PBM), is safe and easy to tolerate. Research indicates that using PBM on the head (transcranial PBM or tPBM) is practical and safe, even for daily home use. Participants reported no serious side effects and often experienced improvements in thinking and memory.

Using PBM through the nose (intranasal PBM or iPBM) also appears promising as a safe treatment. Studies found it improved memory and thinking skills in people with Alzheimer's disease, with no severe side effects noted.

For PBM targeting the vagus nerve (vagus nerve PBM or vPBM), studies suggest it is a safe and innovative way to enhance brain function and mood. No major negative effects were reported.

Overall, current research indicates that PBM treatments are safe. They are non-invasive and seem to be well-tolerated by patients.12345

Why are researchers excited about this trial?

Researchers are excited about photobiomodulation (PBM) for memory loss because it offers a novel, non-invasive approach to potentially enhance cognitive function. Unlike traditional treatments for memory loss, which often involve medications targeting neurotransmitter activity, PBM uses light therapy applied to specific areas like the forehead, nasal passages, or vagus nerve. This method aims to stimulate cellular processes and improve brain health through light exposure, offering a different mechanism of action. The intrigue lies in its potential to provide benefits without the need for pharmaceuticals, reducing the risk of side effects commonly associated with medication.

What evidence suggests that this trial's treatments could be effective for memory loss?

Research has shown that light therapy, known as photobiomodulation (PBM), can improve brain function. This trial will explore different PBM applications: transcranial PBM (tPBM) on the forehead, intranasal PBM (iPBM), and vagal PBM (vPBM) targeting the vagus nerve. Studies have found that tPBM can enhance memory and overall brain performance in older adults. Specifically, iPBM has been linked to significant improvements in people with mild memory problems. Meanwhile, vPBM has shown positive effects on mood and thinking skills. These findings suggest that PBM might help improve memory and mood, making it a promising treatment for those experiencing mild cognitive issues.12456

Are You a Good Fit for This Trial?

This trial is for older adults who feel their memory is getting worse and are concerned about it, but do not have a clinical diagnosis of dementia or other psychiatric or neurological disorders. People with recent substance use issues, certain medical conditions, or those unable to undergo MRI scans cannot participate.

Inclusion Criteria

I feel my memory is getting worse and I am concerned about it.

Exclusion Criteria

I have had a brain injury, stroke, seizures, or brain surgery in the past.
A positive urine toxicology screen for non-prescribed substance use
History of substance-use disorder in the past 12 months
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants use PBM devices at home, 2 times a day, 7 days a week, for 5 weeks

5 weeks
In-home usage

Follow-up

Participants are monitored for safety and effectiveness after treatment, including EEG, MRI, cognitive, and nasal microbiome assessments

2 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Photobiomodulation

Trial Overview

The study tests whether using a non-invasive light therapy device (photobiomodulation) on the forehead, nose, and neck can improve mood and thinking in people worried about memory loss. Participants will use either an active device or a sham (inactive) device at home twice daily for 5 weeks.

How Is the Trial Designed?

4

Treatment groups

Active Control

Placebo Group

Group I: tPBM (forehead PBM)Active Control1 Intervention
Group II: iPBM (intranasal PBM)Active Control1 Intervention
Group III: vPBM (vagus PBM)Active Control1 Intervention
Group IV: ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baycrest

Lead Sponsor

Trials
46
Recruited
6,900+

Citations

Significant Improvement in Cognition in Mild to Moderately ...

This is the first completed PBM case series to report significant, cognitive improvement in mild to moderately severe dementia and possible AD cases.

Photobiomodulation for cognitive dysfunction (Brain Fog) in ...

No effective treatments exist for PCC-related cognitive impairment. Photobiomodulation (PBM), a non-invasive therapy delivering near-infrared light, enhances ...

Photobiomodulation effects on cognitive function — a ...

This systematic review summarizes the effectiveness of photobiomodulation in improving cognitive function across various populations.

Therapeutic potential of intranasal photobiomodulation ... - PMC

In a recent case series (Saltmarche et al., 2017), they have shown that 3-months of transcranial plus intranasal PBMT significantly enhanced cognitive ...

A randomized sham-controlled trial of transcranial and ...

Photobiomodulation (PBM) is a novel strategy for cognitive enhancement by improving brain metabolism and blood flow. It is potentially beneficial for patients ...

Photobiomodulation for Improving Brain Function in ...

The first aim of this trial is to replicate Saltmarche et al' s findings that the effects of 12-weeks of PBM treatment can improve cognitive function in older ...