Abstract
BackgroundPhotobiomodulation describes the use of red or near-infrared light to stimulate or regenerate tissue. It was discovered that near-infrared wavelengths (800–900 nm) and red (600 nm) light-emitting diodes (LED) are able to penetrate through the scalp and skull and have the potential to improve the subnormal cellular activity of compromised brain tissue. Different experimental and clinical studies were performed to test LED therapy for traumatic brain injury (TBI) with promising results. One of the proposals of this present study is to develop different approaches to maximize the positive effects of this therapy and improve the quality of life of TBI patients.Methods/designThis is a double-blinded, randomized, controlled trial of patients with diffuse axonal injury (DAI) due to a severe TBI in an acute stage (less than 8 h). Thirty two patients will be randomized to active coil helmet and inactive coil (sham) groups in a 1:1 ratio. The protocol includes 18 sessions of transcranial LED stimulation (627 nm, 70 mW/cm2, 10 J/cm2) at four points of the frontal and parietal regions for 30 s each, totaling 120 s, three times per week for 6 weeks, lasting 30 min. Patients will be evaluated with the Glasgow Outcome Scale Extended (GOSE) before stimulation and 1, 3, and 6 months after the first stimulation. The study hypotheses are as follows: (1) transcranial LED therapy (TCLT) will improve the cognitive function of DAI patients and (2) TCLT will promote beneficial hemodynamic changes in cerebral circulation.DiscussionThis study evaluates early and delayed effects of TCLT on the cognitive rehabilitation for DAI following severe acute TBI. There is a paucity of studies regarding the use of this therapy for cognitive improvement in TBI. There are some experimental studies and case series presenting interesting results for TBI cognitive improvement but no clinical trials.Trial registrationClinicalTrials.gov, NCT03281759. Registered on 13 September 2017.
Highlights
Photobiomodulation describes the use of red or near-infrared light to stimulate or regenerate tissue
This study evaluates early and delayed effects of transcranial LED therapy (TCLT) on the cognitive rehabilitation for diffuse axonal injury (DAI) following severe acute traumatic brain injury (TBI)
Outcome variables Primary scale [60], the Adams grading scale [58], and Gennarelli’s clinical severity scale [44] for diffuse axonal injury. – Hemodynamic improvement effect of TCLT measured by transcranial Doppler (systolic and diastolic velocities of the middle cerebral (MCA) and basilar arteries (BA) and the pulsatility index and resistance index values) [44]
Summary
Photobiomodulation describes the use of red or near-infrared light to stimulate or regenerate tissue. It was discovered that near-infrared wavelengths (800–900 nm) and red (600 nm) light-emitting diodes (LED) are able to penetrate through the scalp and skull and have the potential to improve the subnormal cellular activity of compromised brain tissue. Different experimental and clinical studies were performed to test LED therapy for traumatic brain injury (TBI) with promising results. It is relevant to mention that these data are likely underestimated, as the data published are solely from hospitalizations only. They probably do not include TBI patients treated in other settings or for whom treatment was not sought [3]
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