None listed
Conditions
Brief summary
Cognitive ability, including memory and problem solving, declines with normal aging. For some people, this decline is more rapid, resulting in a condition known as mild cognitive impairment (MCI). MCI is a precursor for neurological conditions including dementia and Alzheimer’s disease. Despite considerable biotechnology and pharmaceutical investment, current pharmacological treatments for these conditions only temporarily alleviate symptoms with some 50% of people diagnosed showing no benefit with treatment. A growing body of research suggests alternative therapies such as photobiomodulation (PBM) and hyperbaric oxygen therapy (HBOT) may offer benefits to both the symptoms and progression of neurodegenerative diseases. This research will assess whether PBM, also called red light therapy, is an effective treatment for mild to moderate cognitive impairment and whether this effect is heightened by the combined treatment of HBOT. Treatment involves PBM therapy either alone or with HBOT for 8 or 16 weeks depending on treatment arm. Trial participants will undergo MRIs, cognitive tests and a series of blood tests at various time points over a 6-month period to assess immediate and long-term effects of PBM and HBOT on brain structure, function, and cognition. This study is exploratory and will provide important insights for future studies.
Interventions
There will be 3 treatment arms.
All participants will receive:
Photobiomodulation (PBM) will be applied using the WellRed Duo Coronet. This helmet-like device is made of aluminium and has light emitting diodes (LEDs) positioned at regular intervals to cover the entire head. It contains LEDs in two wavelengths of red and near infrared light – 670nm and 810nm. Both wavelengths are pulsed at 40Hz at a voltage of 12V DC, with the 2 wavelengths being automatically switched. Each participant will rece
There will be 3 treatment arms. All participants will receive: Photobiomodulation (PBM) will be applied using the WellRed Duo Coronet. This helmet-like device is made of aluminium and has light emitting diodes (LEDs) positioned at regular intervals to cover the entire head. It contains LEDs in two wavelengths of red and near infrared light – 670nm and 810nm. Both wavelengths are pulsed at 40Hz at a voltage of 12V DC, with the 2 wavelengths being automatically switched. Each participant will receive their own Duo Coronet to self-administer at home twice daily for either 8 weeks (groups 1 & 2) or 16 weeks (group 3). Each session lasts 24 minutes (2x12 minutes consecutively at each wavelength). One treatment arm (group 2) will also receive Hyperbaric Oxygen Therapy (HBOT) at the National Institute of Integrative Medicine (NIIM) clinic twice weekly for 8 weeks in addition to twice daily PBM treatment. Each HBOT session will involve breathing 100% oxygen at atmopheric pressure of 2 Atmospheric Absolute Pressure (ATA) for 60 minutes in NIIM’s Perry Baromedical monoplace HBOT chamber. HBOT sessions will be conducted by a certified nurse and operator. Adherence to daily sessions will be monitored by participant diaries.
Sponsors
Dr Karin Ried
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults with mild to moderate cognitive impairment according to screening test (Telephone Interview for Cognitive Status score <24) Confident/comfortable talking on the phone to conduct screening and schedule appointments. Normal blood test results - Specifically Vit B12
Exclusion criteria
Not able to provide consent Pacemaker Metal/electronic implants or other condition/s making them ineligible for MRI scans Taking potentially photosensitising medication (some types of antidepressants, antibiotics etc.) Poor comprehension of written or spoken English Unable to perform pen and paper or computerized cognitive tests Colour blind
Outcome results
None listed