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

Autor: Poiani GDCR; Division of Neurosurgery, University of Sao Paulo Medical School, Av. Dr. Arnaldo, 455 - Cerqueira César, 01246-903, Sao Paulo, SP, Brazil. comporta.saude@gmail.com., Zaninotto AL; Division of Psychology at Hospital of Clinics, University of Sao Paulo Medical School, Sao Paulo, Brazil.; Division of Neurosurgery, University of Sao Paulo Medical School, Av. Dr. Arnaldo, 455 - Cerqueira César, 01246-903, Sao Paulo, SP, Brazil., Carneiro AMC; Institute of Biomedical Engineering, Anhembi Morumbi University, Sao Jose dos Campos, Sao Paulo, Brazil., Zangaro RA; Institute of Biomedical Engineering, Anhembi Morumbi University, Sao Jose dos Campos, Sao Paulo, Brazil.; Center for Innovation, Technology and Education - CTE, Sao Jose dos Campos, Sao Paulo, Brazil., Salgado ASI; Salgado Institute of Integral Health; School of Postural and Manual Therapy, Londrina, Parana, Brazil., Parreira RB; Salgado Institute of Integral Health; School of Postural and Manual Therapy, Londrina, Parana, Brazil., de Andrade AF; Division of Neurosurgery, University of Sao Paulo Medical School, Av. Dr. Arnaldo, 455 - Cerqueira César, 01246-903, Sao Paulo, SP, Brazil., Teixeira MJ; Division of Neurosurgery, University of Sao Paulo Medical School, Av. Dr. Arnaldo, 455 - Cerqueira César, 01246-903, Sao Paulo, SP, Brazil., Paiva WS; Division of Neurosurgery, University of Sao Paulo Medical School, Av. Dr. Arnaldo, 455 - Cerqueira César, 01246-903, Sao Paulo, SP, Brazil.
Jazyk: angličtina
Zdroj: Trials [Trials] 2018 Jan 08; Vol. 19 (1), pp. 17. Date of Electronic Publication: 2018 Jan 08.
DOI: 10.1186/s13063-017-2414-5
Abstrakt: 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.
Databáze: MEDLINE
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