Effectiveness of Light for Enhancement of Cognition by Transcranial Repeated Application (ELECTRA)
Condition: Disease Type and/or Category Not Applicable
MeSH terms: Disease
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Omnilux
Intervention type(s): Device
Intervention description(s): The Omnilux LED array sources can be changed to emit different wavelength.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: no keywords for disease type and/or category