A Feasibility Study Assessing the Acceptability, Adherence, and Safety of Photobiomodulation (PBM) Therapy and Objective Assessment Measures in Myalgic Encephalomyelitis (ME)

The prevailing theory regarding mechanism of action of PBM is that by activating cytochrome c oxidase (CCO) it boosts mitochondrial ATP production, which, in turn, enhances the metabolic activity of the cell. This occurs simultaneously with the regulation of the reduction/oxidation (redox) state of the intracellular microenvironment favouring expression of genes associated with tissue regeneration and repair. Immune modulation and dampening or attenuation of pro-inflammatory responses ensures a coordinated regenerative effort. An alternate mechanism of action, independent of the absorption of red and near infrared light by CCO, proposes that by reducing the viscosity of interfacial water layers in the predominantly hydrophilic intramitochondrial space PBM increases the speed of rotation and activity of the mitochondrial rotary motor (ATP synthase) that results in increased ATP production. Irrespective of the exact biochemical mechanism of action, crucially, these processes take place in the absence of inciting tissue injury, photothermal effects, or photoacoustic effects.

While the underlying causes of ME/CFS are not know a consistent finding from metabolism-based studies is mitochondrial dysfunction and compromised energy metabolism characterised by high levels of oxidative stress and limited ATP production. Loss of mitochondrial function and compromised ATP production is therefore a plausible explanation for the debilitating chronic fatigue that defines ME/CFS. Based upon prior human studies demonstrating restored ATP production and function investigators hypothesise that PBM and 670nm red light exposure will, by increasing mitochondrial function in ME/CFS patients, improve their physical capacity and cognitive function.

The device that will be used to evaluate red light therapy in ME/CFS patients is an LED lamp that emits a spectrum of light in the red spectrum of visible light, peaking at 670 nm. This lamp was purchased from Planet Lighting Ltd, London, UK; LBT-PAR38-40. This lamp has the following specifications: 1) 40W output, 2) 60o beam angle, 3) 220-240V 50Hz input, 4) E27 base, 5) has a UK Conformity Assessed (UKCA) marking, 6) has CE certification, 7) is Restriction of Hazardous Substances Directive (RoHS) compliant, 8) has a 3 years warranty. It is important to note that this is not a medical device and will be marketed by Planet Lighting as an aid to general health wellbeing lamp for the general population. The Planet Lighting website advertising this product is currently being developed. The director from Planet Lighting has confirmed this in a letter.

Participants will be identified through the UK charity Invest in ME Research. Potential participants are those who have subscribed to the charity. The charity will email subscribers the study flyer and the participant invitation letter. The study flyer and participant invitation letter will include a link to the study specific website on Mantal. The homepage of the study website will contain a summary of the study and a link to the full participant information sheet which ME patients can either download and print or read online.

At the end of the full participant information sheet participants will be instructed on how to provide their informed consent if they wish to participate. Participants will be asked to click on the "register now" button on the homepage of the study website. When participants click on the register now button they will be taken through a series of statements for their consent. If participants consent to all of the statements they will then be taken to a sign up page where participants are able to register for the study with their first and last name and email address. They will be asked to provide a password for their account.