An open label pilot study of photo-biomodulation therapy

UniSC’s Thompson Institute is exploring the safety, feasibility and tolerability of photo-biomodulation therapy (PBMT) on healthy participants aged 50 to 70 years. During the 12-weeks PBMT treatment, the participants will be assessed using cognitive test and by magnetic resonance imaging (MRI).

Why is this study so important?

Cognitive decline and dementias are a significant problem in the public health system due to its magnitude and clinical and social consequences. Alzheimer’s disease is a common, chronic expensive debilitating neurodegenerative disease with no current treatments to prevent the physical deterioration of the brain and the consequent cognitive deficits.

PBMT is a growing approach to many different brain disorders that may be classified as sudden onset (stroke, TBI, global ischemia), neurodegenerative (Alzheimer's, Parkinson's, dementia), or psychiatric (depression, anxiety, posttraumatic stress disorder). PBMT is a safe, non-invasive, and non-thermal modality that is based on a strong body of research dating back to the 1980s. Also known as low-level laser (or light) therapy, it uses either visible red or near infrared light to stimulate, heal, and repair damaged or dying tissue cells.

Eligibility criteria

• 50-70 years old
• Not diagnosed with any neurodegenerative diseases (e.g., dementia, mild cognitive impairment)
• Does not have any significant psychiatric history (e.g., psychosis, bipolar disorder, depression)
• Does not have any unstable medical (e.g., severe hypertension) or neurological condition
• Does not have any severe cardiovascular disease, history of stroke, recent myocardial infraction
• Willing to undergo MRI scanning and PBMT therapy and undertake cognitive assessment

What participation involves

As a participant in the trial for PBMT therapy, you will undergo 12-weeks of PBMT therapy, twice weekly, and a range of assessments, as outlined below.

These assessments are very important in helping us to better understand the cognitive effects of the PBMT therapy and its safety, feasibility and tolerability as a treatment method.

These treatments will take place at the UniSC’s Thompson Institute twice weekly for 12 weeks – i.e., 24 times (30-60 minutes each) in total. The assessments will be conducted two times throughout the trial – before the treatment period, at week 0, and after the last treatment, at week 12.

One assessment will include self-report questionnaires (45 minutes), cognitive assessment (30 minutes), an MRI scan (60 minutes), and an electroencephalography EEG task. If you feel uncomfortable answering these questions or undergoing an MRI or EEG, we have experienced staff members who can offer support and assistance.

Photo-biomodulation therapy:

PBMT is a safe and non-invasive modality which uses either visible red or near infrared light to stimulate, heal, and repair damaged or dying tissue cells. It is a growing approach to multiple different brain disorders which include neurodegenerative diseases (e.g., Alzheimer’s disease, Parkinson’s disease, dementia).

Self-report questionnaires:

The self-report questionnaires will ask about your mental health, overall wellbeing, day-to-day functioning, alcohol consumption, and sleep quality. Other demographic information, such as your employment status, education level, and medical history.

Cognitive assessments:

Cambridge Automated Neuropsychological Test Assessment Battery (CANTAB) is a fully automated, self administered neuropsychological test battery presented on an iPad. Once the participant details have been entered, all instructions and practice trials are delivered by CANTAB and the participant responds as instructed by the CANTAB. Researcher involvement is rarely required, and predominantly only to pause a test protocol should a participant require a rest break. The tests will cover cognitive domains such as memory, information processing and speed as well as executive functioning.

Brain imaging:

Magnetic resonance imaging (MRI) is a non-invasive form of brain imaging which utilises the natural magnetic properties of water molecules to generate signal and therefore build up a 3D map of all the different tissues within the body. These scans can assess structural, functional, and chemical changes in the brain. As part of this protocol, you will be asked to complete a cognitive task in the MRI. EEG Recording: Electroencephalography (EEG) is a non-invasive method for measuring brain activity using electrodes placed on the scalp. It captures real-time fluctuations in electrical voltage to monitor different brain states and cognitive processes. As part of this protocol, you'll be asked to perform a cognitive task while connected to an EEG machine.