None listed
Conditions
Brief summary
The purpose of this study is to evaluate the safety and to explore the effect of a photobiomodulation technique on fatigue severity in individuals with a diagnosis of chronic fatigue. This study will involve photobiomodulation applied to the whole brain in individuals with chronic fatigue. The results obtained from this study will help us to develop new treatments for improving fatigue severity in individuals with chronic fatigue. We hypothesise that, compared to a placebo treatment, tPBM will improve fatigue, energy levels, and thinking skills in people with chronic fatigue. We also predict improvements in brain function linked to better overall health outcomes.
Interventions
Transcranial photobiomodulation (tPBM) will be administered five times per week (20 minutes/session) for a total of three weeks (i.e., a total of 15 sessions) using the Neuradient 1070 light-emitting diodes helmet (Neuronic Devices Ltd, Ireland).
The active groups will receive either continuous (glow) or 40Hz pulsed tPBM at a wavelength of 1070±50nm.
Participants will be seated in a comfortable chair for the duration of the tPBm sessions.
Sessions will take place at an urban public hospital and
Transcranial photobiomodulation (tPBM) will be administered five times per week (20 minutes/session) for a total of three weeks (i.e., a total of 15 sessions) using the Neuradient 1070 light-emitting diodes helmet (Neuronic Devices Ltd, Ireland). The active groups will receive either continuous (glow) or 40Hz pulsed tPBM at a wavelength of 1070±50nm. Participants will be seated in a comfortable chair for the duration of the tPBm sessions. Sessions will take place at an urban public hospital and be carried out by trained clinical and/or academic staff. Allocation to an active or placebo group will be done by random code. Adherence to intervention will be assessed by attendance at sessions.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Participants with a chronic fatigue, irrespective of the cause, will be eligible to participate. Participants will need to: - have fatigue that occurs every day for at least 6 months, - have a score of at least 36 on the fatigue severity scale in the past 7 days, - be capable of understanding and signing an informed consent form. - aged between 18 to 70 years on the day of the consent.
Exclusion criteria
Participants who meet any of the following conditions will be excluded: - Cognitive (e.g. Alzheimer’s disease, dementia) and psychiatric disorders - Underwent any surgery requiring general anaesthetic in the past six months. - Broken/fractured/torn any bones or ligaments within the past six months. - Altered medications in the past one month. - Made major dietary alterations in the past one month. - History of epilepsy, seizures, substance abuse disorders - Electronic implants (e.g. pacemaker) or other metal objects in the brain - Any proliferative disease (e.g. cancer) - Any surface bacterial/fungal infection (e.g. blepharitis) - Any acute or uncontrolled medical conditions - Pregnant or six-months post-partum
Outcome results
None listed