Not yet recruitingNAINTERVENTIONAL

Physiological Effect of Non-invasive Photobiomodulation on Cognition and Mood in Older Adults With Subjective Cognitive Impairment

This study is investigating a new approach called photobiomodulation (PBM) for older adults who notice their memory or thinking skills aren't as sharp as they used to be, even if doctors don't find a problem. This feeling is sometimes linked to changes in mood. PBM involves using specific types of light, often near-infrared, that can be shone on the head or in the nose. Previous research suggests this light might help brain cells work better, improve blood flow, and reduce inflammation. This study will give participants a device to use at home and will observe if PBM can improve mood and brain function. It's a first step to see if this light therapy could be a helpful treatment for memory and thinking problems in the future.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Baycrest

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Jul 2028

Subjective Cognitive Decline (SCD)Subjective Cognitive Impairment

What is this study about?

This study is exploring a new way to help older adults who've noticed their memory or thinking skills aren't quite what they used to be. Sometimes, people feel their cognitive abilities are declining even when medical tests don't show a clear problem. This is called 'subjective cognitive impairment' (SCI), and it can often go hand-in-hand with changes in mood.

The main treatment being tested is called photobiomodulation (PBM). This sounds complex, but it simply means using special forms of light, specifically near-infrared light. This light is non-invasive, meaning it doesn't involve surgery or needles. We know that this kind of light therapy has shown some promise in other areas, like helping brain cells work better, improving blood flow, and reducing swelling (inflammation) in the brain. It's even been looked at in people with memory problems like dementia or mood conditions like depression.

In this study, we want to see if using PBM on the forehead, inside the nose, or on the neck can improve mood and thinking skills in people with SCI. This research is a really important first step to understand if PBM could become a recognised therapy for cognitive decline in the future. We're hoping to gather 'proof of concept' – evidence that the idea works – which could then lead to larger studies.

Key takeaways

This study explores light therapy (PBM) for self-reported memory decline.
It aims to improve mood and thinking skills in older adults.
Participation involves using a home device daily for 5 weeks.
Assessments include brain scans (EEG, MRI) and cognitive tests.
It helps us understand if PBM could be a future brain health treatment.

Who may be eligible?

This study is looking for people aged between 50 and 75 years old.

You might be suitable to take part if you've noticed your memory is getting worse and you're worried about it. This is a key part of what the study is looking for.

However, there are some reasons why you might not be able to join. For example, if you've been diagnosed with dementia, mild cognitive impairment, depression, or certain other mental health conditions, this study won't be right for you. We also can't include people who have had significant brain injuries, strokes, seizures, or certain other serious medical or neurological illnesses. If you're currently taking medications that thin your blood, or if you can't have an MRI scan for medical reasons, you also wouldn't be able to participate. It's also important that you're not involved in another study that involves an intervention or treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 50 and 75 years old?
Do you feel your memory is getting worse, and are you concerned about it?
Have you NOT been diagnosed with dementia or other serious mental health conditions?
Do you NOT have serious brain injuries, strokes, or currently take blood thinners?
Are you NOT involved in any other medical intervention studies right now?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in the study for a total of 5 weeks. We'll ask about 80 people to join.

Here’s what your participation would involve:

Before you start, and after the 5 weeks, you'll have a few assessments. These include an EEG (which measures brain activity), an MRI scan (a special type of scan that looks at your brain), some tests to check your thinking and memory, and a small sample taken from your nose to look at bacteria (called a nasal microbiome assessment).

You'll be given a special device called Neuro 5T to use at home. This device looks a bit like a headset and has small lights (LEDs) that shine light on your forehead, inside your nose, and on your neck. You will be asked to use this device twice a day, every day, for the full 5 weeks. You might be given a device that delivers the special light therapy, or a 'sham' device that looks exactly the same but doesn't deliver the active light, so we can compare the effects fairly.

Potential risks and benefits

Participating in this study might offer some potential benefits, though these are not guaranteed. You might experience improvements in your mood or thinking skills, or you might find comfort in contributing to research that could help others in the future. As with any study, there are potential risks, such as minor discomfort from the device or during assessments like the MRI. The study team will explain all potential side effects of the light device and assessments in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Rotman Research Institute
Verified postcode
Toronto, Canada

Common questions

What is photobiomodulation (PBM)?

PBM is a treatment that uses special light, often near-infrared, to help brain cells work better, improve blood flow, and reduce swelling in the brain. It's non-invasive, meaning no surgery or needles are involved.

What is 'subjective cognitive impairment'?

This is when you feel your memory or thinking skills are declining, even if doctors don't find a problem during standard tests. It's a personal feeling of decline.

Will I know if I'm getting the real treatment or a 'sham' device?

No, you won't know during the study. This is common in research to make sure the results are fair and not influenced by what people expect. Sometimes, you might be told at the end of the study.

How long will I be in the study, and how often do I use the device?

Your participation will last for 5 weeks. You'll need to use the light device at home twice a day, every day, for those 5 weeks.

Are there any strong side effects from the light therapy?

The research team will discuss all possible side effects, but generally, mild irritation or discomfort during use might occur. The therapy is considered non-invasive.

How to find out more

Principal Investigator

jean.chen@utoronto.ca 416-785-2500 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.