Journal Article

Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol

de Andrade, Almir Ferreira, Poiani, Guilherme da Cruz Ribeiro, Salgado, Afonso Shiguemi Inoue, Teixeira, Manoel Jacobsen, Carneiro, Ana Maria Costa, Zangaro, Renato Amaro, Paiva, Wellingson Silva, Zaninotto, Ana Luiza, Parreira, Rodolfo Borges

2018

Overview

Background Photobiomodulation using low-level laser therapy (LLLT) has been tested as a new technique to optimize recovery of patients with traumatic brain injury (TBI). The aim of this study is to evaluate inhibitory attentional control after 18 sessions of active LLLT and compare with the placebo group (sham LLLT). Our exploratory analysis will evaluate the efficacy of the active LLLT on verbal and visuospatial episodic memory, executive functions (working memory, verbal and visuospatial fluency, attentional processes), and anxiety and depressive symptoms compared to the sham group. Methods/Design A randomized double-blinded trial will be made in 36 patients with moderate and severe TBI. The active LLLT will use an optical device composed of LEDs emitting 632 nm of radiation at the site with full potency of 830 mW. The cranial region with an area of 400 cm 2 will be irradiated for 30 min, giving a total dose per session of 3.74 J/cm 2 . The sham LLLT group contains only an LED device with power < 1 mW, only serving to simulate the irradiation. Each patient will be irradiated three times per week for six weeks, totaling 18 sessions. Neuropsychological assessments will be held one week before the beginning of the sessions, after one week, and three months after the end of LLLT sessions. Memory domain, attention, executive functioning, and visual construction will be evaluated, in addition to symptoms of depression, anxiety, and social demographics. Discussion LLLT has been demonstrated as a safe and effective technique in significantly improving the memory, attention, and mood performance in healthy and neurologic patients. We expect that our trial can complement previous finds, as an effective low-cost therapy to improve cognitive sequel after TBI. Trial registration ClinicalTrials.gov, NCT02393079 . Registered on 20 February 2015.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / Adult / Affect - radiation effects / Animal cognition / Anxiety / Anxiety - diagnosis / Anxiety - physiopathology / Anxiety - psychology / Anxiety - therapy / Attention - radiation effects / Biomedicine / Brain / Brain - radiation effects / Brain Injuries, Traumatic - diagnosis / Brain Injuries, Traumatic - physiopathology / Brain Injuries, Traumatic - psychology / Brain Injuries, Traumatic - radiotherapy / Brain Injury, Chronic - diagnosis / Brain Injury, Chronic - physiopathology / Brain Injury, Chronic - psychology / Brain Injury, Chronic - radiotherapy / Brazil / Care and treatment / Clinical trials / Cognition / Consent / Depression / Depression - diagnosis / Depression - physiopathology / Depression - psychology / Depression - therapy / Disability / Double-Blind Method / Emergency medical care / Executive Function - radiation effects / Female / Health Sciences / Helmets / Hematoma / Humans / Injuries / Intervention / Laser therapy / Light therapy / Low-Level Light Therapy - adverse effects / Low-Level Light Therapy - methods / Male / Medicine / Medicine & Public Health / Memory / Memory, Episodic / Mental depression / Mental illness / Methods / Middle Aged / Multicenter Studies as Topic / Neuropsychological Tests / Outpatient care facilities / Patients / Photobiomodulation / Prospective Studies / Radiation Dosage / Randomized Controlled Trials as Topic / Risk factors / Statistics for Life Sciences / Stroke / Study Protocol / Time Factors / Transcription factors / Trauma / Traumatic brain injury / Treatment Outcome / Young Adult