None listed
Conditions
Brief summary
This study is an open-label trial investigating the safety, feasibility, and tolerability of photo-biomodulation Therapy (PBMT) on healthy participants aged 50 to 70 years. Photo-biomodulation (PBMT) employs red or near-infrared (NIR) light (600-1100nm) to stimulate healing, protect tissue from dying, increase mitochondrial function, improve blood flow, and tissue oxygenation (Dompe et al., 2020; Hamblin, 2018). PBMT can also act to reduce swelling, increase antioxidant defence, decrease inflammation, protect against apoptosis, and modulate microglial activation states (de Freitas & Hamblin, 2016; Hamblin, 2017). All these mechanisms of action strongly suggest that PBMT delivered to the head could be beneficial in cases of mild cognitive impairment and dementia (Hamblin, 2016; Hennessy & Hamblin, 2016). The study will also determine the relevant parameters of PBMT that will be used to design a larger randomised blinded trial. We hypothesize that the (1) PBMT intervention will be safe and tolerable for an older adult population and (2) the treatment will result in discernible changes in MRI measures and these will be correlated to improvements on neuropsychological assessment outcomes on the CANTAB that reflect decision making and working memory constructs, as well as EEG measures of attention and working memory. The 12-week intervention will include participants undergoing pre-treatment assessments (week 0), 12 weeks of PBMT (week 1-12), and post-treatment assessments (week 12). The PBMT trial will be evaluated against baseline verse follow up cognitive, psychological, and neuroanatomical changes, along with participant safety and tolerability (number and severity of adverse events) and program completion (actual treatment completed).
Interventions
An open label pilot study of photo-biomodulation therapy (PBMT).
The main goal of the study is to examine the safety and tolerability of transcranial PBMT with a helmet style of device for healthy participants aged 50-70 years. Participants will be on their “treatment as usual” regimen which implies that they will continue to take all their regular medications. The PBMT treatment will be adjunctive.
The proposed open-label trial will comprise of a single treatment arm, whereby healthy partici
An open label pilot study of photo-biomodulation therapy (PBMT). The main goal of the study is to examine the safety and tolerability of transcranial PBMT with a helmet style of device for healthy participants aged 50-70 years. Participants will be on their “treatment as usual” regimen which implies that they will continue to take all their regular medications. The PBMT treatment will be adjunctive. The proposed open-label trial will comprise of a single treatment arm, whereby healthy participants aged 50 to 70 years (N=30) will receive PBMT treatment twice per week for 12 weeks. For each session, the participant will be instructed to sit upright in a chair with their eyes open whilst wearing the helmet device to receive 20 minutes (exposure time) of photo-biomodulation treatment with pulse mode setting, square wave time 20Hz/min and light intensity of 20%. PBMT treatments will occur twice a week with at least 2 days apart in between at the Thompson Institute. The PBMT session will be performed by trained PBMT technicians and researchers. All participants will be informed that they will receive PBMT treatment. Neuropsychological and self-report assessments along with Magnetic Resonance Imaging (MRI) and Electroencephalogram (EEG) will occur at entry into the study (week 0) and after the treatment period (week 12). If a participant is unable to attend or misses a treatment session, details of the deviation, including reason for failure to attend, will be recorded in the source documentation. If participants miss more than two weeks of PBMT treatment, they will be excluded from the study.
Sponsors
The University of the Sunshine Coast
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
- Persons aged 50-70 years. - Participants must be able to understand Research Project Information Sheet (RPIS) and provide written informed consent on the Participant Informed Consent Form (PICF). - Participants must be able to undergo MRI, undertake neuropsychological and EEG assessments, and tolerate the PMBT therapy.
Exclusion criteria
- Diagnosed dementia and mild cognitive impairment - Significant psychiatric history including psychosis, bipolar disorder, major depressive disorder including suicidality. - Any unstable medical (e.g., severe/uncontrolled hypertension) or neurological condition (e.g., Parkinson’s Disease) - Severe cardiovascular disease, history of stroke, recent myocardial infarction - Any contraindication to MRI or PBMT therapy - Development of serious, adverse, or unexpected events/reactions during the trial - Previous reaction to PBMT therapy
Outcome results
None listed