Poiani Guilherme da Cruz Ribeiro, Zaninotto Ana Luiza, Carneiro Ana Maria Costa, Zangaro Renato Amaro, Salgado Afonso Shiguemi Inoue, Parreira Rodolfo Borges, de Andrade Almir Ferreira, Teixeira Manoel Jacobsen, Paiva Wellingson Silva
Division of Neurosurgery, University of Sao Paulo Medical School, Av. Dr. Arnaldo, 455 - Cerqueira César, 01246-903, Sao Paulo, SP, Brazil.
Division of Psychology at Hospital of Clinics, University of Sao Paulo Medical School, Sao Paulo, Brazil.
Trials. 2018 Jan 8;19(1):17. doi: 10.1186/s13063-017-2414-5.
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 will be irradiated for 30 min, giving a total dose per session of 3.74 J/cm. 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.
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.
ClinicalTrials.gov, NCT02393079 . Registered on 20 February 2015.
使用低强度激光疗法（LLLT）的光生物调节已作为一种优化创伤性脑损伤（TBI）患者恢复的新技术进行了测试。本研究的目的是评估18次主动LLLT治疗后的抑制性注意力控制，并与安慰剂组（假LLLT）进行比较。我们的探索性分析将评估主动LLLT与假手术组相比，对言语和视觉空间情景记忆、执行功能（工作记忆、言语和视觉空间流畅性、注意力过程）以及焦虑和抑郁症状的疗效。
方法/设计：将对36例中重度TBI患者进行随机双盲试验。主动LLLT将使用一种光学装置，该装置由发射632nm辐射的发光二极管组成，在该部位的最大强度为830mW。将对面积为400平方厘米的颅骨区域照射30分钟，每次照射的总剂量为3.74J/cm。假LLLT组仅包含一个功率小于1mW的发光二极管装置，仅用于模拟照射。每位患者每周接受三次照射，持续六周，共18次。在治疗开始前一周、治疗一周后以及LLLT治疗结束后三个月进行神经心理学评估。除了抑郁、焦虑症状和社会人口统计学特征外，还将评估记忆领域、注意力、执行功能和视觉构建能力。
LLLT已被证明是一种安全有效的技术，可显著改善健康和神经系统疾病患者的记忆、注意力和情绪表现。我们期望我们的试验能够补充先前的研究结果，作为一种有效的低成本疗法来改善TBI后的认知后遗症。
ClinicalTrials.gov，NCT02393079。于2015年2月20日注册。
