Photobiomodulation (PBM) uses characteristics of artificial light or sunlight, including infrared, ultraviolet, visible light, and laser to modulate biological activity. Efforts in the past decades have however focused on the physiological effects of red light and near-infrared radiation. PBM with infrared light penetrates the tissue to stimulate mitochondria, thereby increasing cellular respiration and adenosine triphosphate (ATP) production. Specifically, it has been suggested that PBM up-regulates complex IV of the respiratory chain to modulate cytochrome c oxidase (CCO) leading to increased ATP formation (Hennessy 2017). This increased availability of energy in the form of ATP leads to cellular growth and repair (Tsai 2017, Salehpour 2018, Dompe 2020). More active mitochondria support higher oxygen / glucose consumption supporting increased cerebral blood flow (Tian 2016, Urquhart 2020).
Using a laser diode to deliver PBM provides the benefit of high energy density, good directivity (directional radiation and small divergence angle), pure monochromaticity (the purest light color and single light wave frequency), and good coherence (Konishi 2007). When delivered to the brain, transcranial PBM (tPBM) with low-level laser in the near-infrared range can penetrate the skin and skull and have neurostimulation effects. There is encouraging evidence that tPBM can have beneficial effects on traumatic events (stroke, traumatic brain injury, and global ischemia), degenerative diseases (dementia, Alzheimer's and Parkinson's), psychiatric disorders (depression, anxiety, post traumatic stress disorder) (Hamblin 2016, Cassano 2018, Iosifescu 2022), and lead to cognitive enhancement (Spera 2021). tPBM is also appealing because it has a good safety profile and is easy to administer (Askalsky 2019).
Many factors influence its effect, such as treatment timing, pulsing, and wavelength (Tsai 2017). To accommodate for this, NeuroThera’s device can deliver a range of wavelengths, irradiances, and exposure times to ensure the best treatment options.
Clinical studies of tPBM reliably and reproducibly show it to be safe, but they are inconsistent in demonstrating efficacy due to different doses used.
As opposed to using LED sources that have “un-controlled” irradiance profiles, the NeuroThera solution uses fiber-coupled laser sources delivering light through a beam homogenizer. This ensures uniform irradiance distribution and provides the flexibility of delivering light anywhere in the head. Further, our default solution delivers stimulation to at least 12 cm2 of the intended targeted region. Finally, we provide the highest power option in the industry.
The purpose of this research study is to determine if application of near infrared energy to the forehead can change blood flow in the brains of people with depression. This research study will compare near infrared exposure with a placebo or sham procedure. The sham procedure will look and feel just like the near infrared procedure but won't include near infrared exposure. This study will compare the effect of three tPBM doses (high, middle, and low irradiance) to sham tPBM on PFC CBF as assessed with fMRI (BOLD) in this multi-center, phase I, double-blinded, dose-ranging, controlled, crossover study of 30 subjects with MDD. All eligible participants will undergo four sessions of tPBM during fMRI so that they experience irradiances of 50, 300 and 700 mW/cm2 as well as sham. The order of dose administration will be randomized.
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This study will be the first to evaluate the dose-dependent effects of tPBM in amnestic Mild Cognitive Impairment (aMCI) (CDR of 0.5-1, FAST 1-3; age 65-85) in a randomized clinical trial of 8 weeks of tPBM vs. sham. At screening, all subjects will complete initial neuropsychological testing. To elucidate mechanisms of action of tPBM, prior to treatment, subjects will undergo neuroimaging related to critical features of AD: tau 18F MK-6240 load (PET), measures of brain bioenergetics (31P-MRS), and functional connectivity (rs-fMRI). Subjects will also undergo an open label tPBM session performed during fMRI to detect BOLD changes with t-PBM. Subjects will then be randomized to t-PBM/sham and complete treatments in two participating centers (NYU/NKI acting as a single center, and MGH), ~10 min per day, 3 days per week, for 8 weeks. tPBM will be administered via pulsed, 808nm wavelength laser delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3).
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