Active not recruitingNAINTERVENTIONAL

Effect of Transcranial Near InfraRed Light on Cerebral Function in Young and Healthy Older Subjects: a FMRI Study (TIROC)

Doctors are studying a new treatment called transcranial photobiomodulation (tPBM), which involves shining a special near-infrared light on the head. We want to see if this light can improve how the brain works in healthy people. The study will compare two groups: healthy younger adults (18-40) and healthy older adults (60-85). Participants will either receive the active light treatment or a dummy (sham) treatment. We will use a special brain scan called fMRI to measure brain activity during a simple finger-tapping task before and after the treatment. The researchers believe this light therapy might boost brain function, especially in older individuals.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

Start

01 Sep 2023

Estimated completion

15 May 2026

Healthy Volunteers

What is this study about?

This study is exploring a gentle and non-invasive technique called transcranial photobiomodulation (tPBM), which involves directing a special kind of light, similar to red light, onto the head. Scientists have observed in many studies, including those on animals, that this type of light may have a positive effect on how the brain works and could even protect brain cells. What we don't fully understand yet is exactly how it works in humans, especially in different age groups.

The main goal of this particular study is to see if tPBM can improve brain function in healthy people. We're especially interested in whether this effect is more noticeable in older adults compared to younger adults. To find this out, participants will undergo special brain scans called fMRI (functional Magnetic Resonance Imaging). These scans allow us to see which parts of the brain are active when someone performs a task, such as tapping their fingers. We'll do these scans before and after a session of either the active light treatment or a dummy treatment, called a sham, to see if there's a difference.

In simple terms, the light is thought to help the tiny powerhouses within our brain cells, called mitochondria, work more efficiently. This could lead to more energy for brain cells, potentially improving their function. This treatment is appealing because it doesn't involve medicines or surgery, and so far, no serious side effects have been reported. While early findings are promising for various conditions, this study aims to provide clearer answers about how this light therapy affects the healthy human brain, particularly as we age.

Key takeaways

Exploring light therapy (tPBM) on the brain.
Compares younger and older healthy adults.
Uses fMRI scans to measure brain activity.
Investigates if light improves brain function, especially in older people.
No drugs or surgery involved, treatment is non-invasive.
Participation helps future understanding of brain health.

Who may be eligible?

To join this study, you must be either a man or a woman. In terms of age, you need to be in one of two groups: either between 18 and 40 years old (the younger group) or between 60 and 85 years old (the older group). It's important that you are right-handed. You also shouldn't be taking certain medications like strong mood-altering drugs or antidepressants. Your vision should be normal or corrected with glasses or contact lenses.

There are some reasons why you might not be able to take part. For example, if you have memory problems, a brain/nerve condition, a mental health illness, or a physical problem that makes it hard to move your hands, you wouldn't be eligible. You also can't participate if you have any metal in your body (like some implants or pacemakers) that would prevent you from having an MRI scan, or if you have extreme claustrophobia. Your score on a quick memory test called the MoCA also needs to be 26 or higher.

Also, certain groups are not allowed to participate in biomedical research according to UK law, including pregnant or breastfeeding women, people in prison, those receiving mental health care against their will, minors (under 18), and individuals under legal protection (like guardianship). You also can't be currently participating in another clinical study or already have received a lot of money (over 4500 Euros or roughly £3800) from other research studies in the past year.

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 18-40 or 60-85 years old?
Are you right-handed?
Do you have good overall health, without serious memory or nerve problems?
Are you able to have an MRI scan (no metal implants or severe claustrophobia)?
Are you not currently taking strong mood-altering medications?
Are you not pregnant, breastfeeding, or under specific legal protections?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study centre for your appointments. During these visits, you'll have a special brain scan called an fMRI, which helps us look at your brain activity. You'll also do a simple finger-tapping task. After these initial checks, you'll receive either the active light treatment or a dummy (sham) treatment for about 24 minutes. You won't know which one you're getting, and neither will the researchers, to keep the study fair. After the treatment, you'll have another fMRI scan and repeat the finger-tapping task. There are no medications involved in this study. The total time for your participation will be spread across a few visits, and we expect the whole process to be completed within a relatively short period for each participant.

Potential risks and benefits

The potential benefits of participating aren't guaranteed, but your involvement could help us understand more about how this light therapy affects the brain, which might lead to new treatments in the future. For you personally, there's a chance the active light treatment could temporarily improve brain function, though this isn't certain. The main risks are generally low; the fMRI scan involves strong magnets but no radiation, and the light treatment hasn't shown serious side effects. However, minor discomfort or anxiety from being in the scanner could occur. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Clinatec Cea/Chuga
Verified postcode
Grenoble, France

Common questions

What is transcranial photobiomodulation (tPBM)?

It's a treatment where a special, safe light (near-infrared) is shined onto your head, thought to help your brain cells work better.

What is a 'sham' treatment?

It's like a dummy treatment that looks and feels like the real thing, but without the active light. This helps us fairly compare the effects.

What is an fMRI scan?

It's a special type of scan that uses strong magnets to look at your brain activity, showing which parts of your brain are working when you do tasks.

Will I know if I'm getting the real treatment or the dummy one?

No, neither you nor the study staff will know, to make sure the results are as unbiased as possible.

Is this light treatment safe?

So far, similar light devices have been approved for other uses, and this treatment hasn't shown any serious side effects in studies.