An Early Phase 1 interventional study of Omnilux in Disease Type and/or Category Not Applicable, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Other
Aim: Investigate whether transcranial photobiomodulation (tPBM) using near-infrared light exposure to the head, can improve frontal lobe executive function, working memory and overall mood in normal volunteer participants.
Hypothesis: The investigators predict that tPBM will increase cognitive functioning, as measured by Cambridge Cognition cognitive testing in study subjects.
Photobiomodulation (PBM), also called low-level light therapy (LLLT), uses optical power densities less than 100 mW/cm², and usually in the red (600-700 nm) or near infrared (NIR) 780-1000 nm wavelength range. Different light sources (coherent lasers or non-coherent LEDs) used for PBM have been shown to produce beneficial cellular effects and to be responsible for preservation and recovery of tissue function in controlled trials in a wide range of disorders typified by stress injury or degeneration. During PBM, absorption of red or near-infrared photons by cytochrome c oxidase in the mitochondrial respiratory chain causes an increase in cellular respiration that continues for much longer than the light is present when delivered at appropriate fluence and exposure durations.
Primary cellular effects include increases in mitochondrial activity and ATP levels, production of low levels of reactive oxygen species, induction of transcription factors (including the pro- survival NF-kB), and inhibition of apoptosis.
Over the past decade several studies have reported that a single, transcranial PBM treatment at 810 nm delivered to the head had significant, beneficial effect when used to treat acute ischemic stroke in several different animal models and also in human clinical trials. A similar approach was used to treat acute traumatic brain injury (TBI) in mice and in humans. Pathological examination of the mouse brains demonstrated up- regulation of brain-derived neurotrophic factor (BDNF) and stimulated neurogenesis in the hippocampus and increased synaptogenesis in the cortex.
A clinical trial is currently in progress at MGH to treat persons with acute moderate TBI. Several studies have shown improvement of cognitive function in persons with chronic TBI. Studies have also been conducted in animal models and in persons with Alzheimer's disease, Parkinson's disease, depression and anxiety.
Only a very limited number of studies have so far been carried out to test NIR photobiomodulation in normal experimental rodents and in normal human volunteers.
In this study, an LED array light source will be used that has been cleared by the FDA for other human uses.
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
An Omnilux device will be used to put NIR light on the head and forehead of the subject age 18-25 or 65-85. The device is a low risk device as determined by the IRB. Thirty (30) subjects will receive this light at 6 visits over 16 weeks. An automated interactive software self-test will be used at baseline and at three subsequent visits to quantify subject cognitive functions.
Device: Omnilux
An Omnilux Device will be used at a safe wavelength not associated with photobiomodulation, putting sham light on the head and forehead of the subject age 18-25 or 65-85. The device is a low risk device as determined by the IRB. Thirty (30) subjects will receive this light at 6 visits over 16 weeks. An automated interactive software self-test will be used at baseline and at three subsequent visits to quantify subject cognitive functions.
Device: Omnilux
The Omnilux LED array sources can be changed to emit different wavelength.
ERT: Emotional Recognition Task
The median latency from stimulus onset to the subject's response button touch (i.e. emotion chosen) for all problems during assessment blocks.
Time frame: 16 weeks
PAL: Paired Associates Learning
The number of times the subject chose the incorrect box for a stimulus on assessment problems, plus an adjustment for the estimated number of errors they would have made on any problems, attempts and recalls they did not reach
Time frame: 16 weeks
RTI: Reaction Time
The mean duration between the onset of the stimulus and the release of the button. Calculated for correct, assessed trials where the stimulus could appear in any one of five locations.
Time frame: 16 weeks
RVP: Rapid Visual Information Processing
A' (A prime) is the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range is 0.00 to 1.00; bad to good). In essence, this metric is a measure of how good the subject is at detecting target sequences.
Time frame: 16 weeks
SST: Stop Signal Task
The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials.
Time frame: 16 weeks
SWM: Spatial Working Memory
Between errors are defined as times the subject revisits a box in which a token has previously been found. This is calculated for trials of four, six and eight tokens.
Time frame: 16 weeks
Plan to share: Yes — Data will only be shared within the study staff member on the approved Institutional Review Board MGH protocol and to the sponsor, the AFOSR
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital